8,612 results match your criteria Journal of Bioequivalence & Bioavailability [Journal]


Gene expression profiles of human granulosa cells treated with bioequivalent doses of corifollitropin alfa (CFA) or recombinant human follicle-stimulating hormone (recFSH).

Gynecol Endocrinol 2019 Feb 20:1-5. Epub 2019 Feb 20.

a Department of Medical and Surgical Sciences for Children and Adults , University of Modena and Reggio Emilia , Modena , Italy.

Using recombinant DNA technologies, a chimeric gene containing the coding sequences of follicle stimulating hormone (FSH) β-subunit and C-terminal peptide of the human chorionic gonadotrophin (hCG) β-subunit have been designed to generate a new gonadotrophin named corifollitropin alfa (CFA). CFA has longer elimination half-life and slower rate of absorption compared with FSH, which makes CFA a long-acting hormone employed as a substitute of the recombinant FSH (recFSH) in the controlled ovarian stimulation (COS). The purpose of this study is to compare the gene expression profiles elicited by bioequivalent doses of CFA or recFSH in primary cultures of human granulosa cells (hGCs). Read More

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http://dx.doi.org/10.1080/09513590.2019.1576611DOI Listing
February 2019

Comparison of false-positive rates of 2 hypothesis-test approaches in relation to laboratory toxicity test performance.

Environ Toxicol Chem 2019 Feb 18. Epub 2019 Feb 18.

US Environmental Protection Agency, Region 9, San Francisco, California.

We compared 2 statistical hypothesis-test approaches (no-observed-effect concentration [NOEC] and test of significant toxicity [TST]) to determine the influence of laboratory test performance on the false-positive error rate using the US Environmental Protection Agency's Ceriodaphnia dubia reproduction whole-effluent toxicity (WET) test endpoint. Simulation and power calculations were used to determine error rates based on observed control coefficients of variation (CV) for 8 laboratories over a range of effect levels. Average C. Read More

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http://doi.wiley.com/10.1002/etc.4347
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http://dx.doi.org/10.1002/etc.4347DOI Listing
February 2019
1 Read

A semiphysiological population pharmacokinetic model of agomelatine and its metabolites in Chinese healthy volunteers.

Br J Clin Pharmacol 2019 Feb 14. Epub 2019 Feb 14.

Research Institute of Drug Metabolism and Pharmacokinetics, Xiangya School of Pharmaceutical Sciences, Central South University, Changsha, China.

Aims: Agomelatine is an antidepressant for major depressive disorders. It undergoes extensive first-pass hepatic metabolism, and displays irregular absorption profiles and large interindividual variability (IIV) and interoccasion variability (IOV) of pharmacokinetics. The objective of this study was to characterize the complex pharmacokinetics of agomelatine and its metabolites in healthy subjects. Read More

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http://dx.doi.org/10.1111/bcp.13902DOI Listing
February 2019

Dissolution and Translational Modeling Strategies Toward Establishing an In Vitro-In Vivo Link-a Workshop Summary Report.

AAPS J 2019 Feb 11;21(2):29. Epub 2019 Feb 11.

Pharmaceutical Sciences, Merck & Co., Inc., 770 Sumneytown Pike, WP75B-210, West Point, Pennsylvania, 19486-0004, USA.

This publication summarizes the proceedings of day 2 of a 3-day workshop on "Dissolution and Translational Modeling Strategies Enabling Patient-Centric Product Development." Patient-centric drug product development from a drug product quality perspective necessitates the establishment of clinically relevant drug product specifications via an in vitro-in vivo link. Modeling and simulation offer a path to establish this link; in this regard, physiologically based modeling has been implemented successfully to support regulatory decision-making and drug product labeling. Read More

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http://dx.doi.org/10.1208/s12248-019-0298-xDOI Listing
February 2019

Randomized, Open-Label, Crossover Studies Evaluating the Effect of Food and Liquid Formulation on the Pharmacokinetics of the Novel Focal Adhesion Kinase (FAK) Inhibitor BI 853520.

Target Oncol 2019 Feb 11. Epub 2019 Feb 11.

Department of Medical Oncology, Erasmus MC Cancer Institute, Groene Hilledijk 301, 3075 EA, Rotterdam, The Netherlands.

Background: BI 853520 is a potent inhibitor of focal adhesion kinase and is currently under clinical development for the treatment of non-hematological malignancies.

Objective: The objective of this study was to evaluate the effect of food and liquid dispersion on the pharmacokinetics of BI 853520 in two open-label, crossover substudies.

Patients And Methods: Sixteen patients with advanced solid tumors were enrolled in each substudy. Read More

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http://dx.doi.org/10.1007/s11523-018-00618-0DOI Listing
February 2019
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No clinically relevant interactions of St. John's wort extract Ze 117 low in hyperforin with cytochrome P450 enzymes and P-glycoprotein.

Clin Pharmacol Ther 2019 Feb 10. Epub 2019 Feb 10.

Max Zeller Soehne AG, Romanshorn, Switzerland.

Hypericum perforatum L. (St. John's wort) is used to treat mild-to-moderate depression. Read More

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http://dx.doi.org/10.1002/cpt.1392DOI Listing
February 2019
1 Read

Switching medication products during the treatment of psychiatric illness.

Int J Psychiatry Clin Pract 2019 Feb 8:1-12. Epub 2019 Feb 8.

d Department of Pharmacology & Therapeutics , McGill University, McIntyre Medical Science Building , Montréal , QC , Canada.

Background: The common practice of switching between branded (reference) medications and their corresponding generic products, between generic products, or even from a generic product to a branded medication during the treatment of central nervous system (CNS) disorders may compromise efficacy and/or tolerability.

Methods: We assessed the published literature from March 1, 2010 through June 30, 2017 via PubMed using the MeSH term 'generics, drugs' alone and in combination with class-specific terms (e.g. Read More

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http://dx.doi.org/10.1080/13651501.2018.1508724DOI Listing
February 2019
1 Read

Sex-by-formulation interaction in bioequivalence trials with transdermal patches.

Eur J Clin Pharmacol 2019 Feb 6. Epub 2019 Feb 6.

Service on Pharmacokinetics and Generics, Division of Pharmacology and Clinical Evaluation, Department of Human Use Medicines, Spanish Agency for Medicines and Health Care Products (AEMPS), C/ Campezo 1, Edificio 8, Planta 2 A, 28022, Madrid, Spain.

Purpose: The existence of a sex-by-formulation interaction in bioequivalence studies implies that the bioequivalence results (i.e., the test/reference ratio of the pharmacokinetic parameters) obtained in one sex are not similar to those obtained in the other sex. Read More

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http://link.springer.com/10.1007/s00228-019-02632-1
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http://dx.doi.org/10.1007/s00228-019-02632-1DOI Listing
February 2019
2 Reads

Functional equivalency in human somatic cell nuclear transfer - derived endothelial cells.

Stem Cells 2019 Feb 5. Epub 2019 Feb 5.

Department of Stem Cell Biology, Konkuk University, School of Medicine, Seoul, Republic of Korea.

The derivation of human embryonic stem cells (hESCs) by somatic cell nuclear transfer (SCNT) has prompted a re-emerging interest in utilizing such cells for therapeutic cloning. Despite recent advancements in derivation protocols, the functional potential of CHA-NT4 derived cells is yet to be elucidated. For this reason, this study sought to differentiate CHA-NT4 cells toward an endothelial lineage in order to evaluate in vitro and in vivo functionality. Read More

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http://dx.doi.org/10.1002/stem.2986DOI Listing
February 2019

Use of roller compaction and fines recycling process in the preparation of erlotinib hydrochloride tablets.

Eur J Pharm Sci 2019 Feb 2;131:99-110. Epub 2019 Feb 2.

School of Pharmacy, Sungkyunkwan University, Suwon 16419, Republic of Korea. Electronic address:

This study focuses on improving the manufacturing process for a generic immediate-release tablet containing erlotinib hydrochloride by adding a fines recycling process during roller compaction. Due to the large fraction of small-sized API particles, the starting powder mixture was inconsistently fed into the roller compactor. Consequently, poorly flowing granules with a high ratio of fines were produced. Read More

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http://dx.doi.org/10.1016/j.ejps.2019.01.036DOI Listing
February 2019
1 Read

Is Bioequivalence Established Based on the Reference-Scaled Average Bioequivalence Approach Relevant to Chronic Administration of Phenytoin? Perspectives Based on Population Pharmacokinetic Modeling and Simulations.

J Clin Pharmacol 2019 Feb 4. Epub 2019 Feb 4.

Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.

Phenytoin demonstrates time-dependent and nonlinear pharmacokinetics (PK) within the therapeutic range of 10 to 20 μg/mL. There are discussions on the relevance of bioequivalence (BE) demonstrated in a single-dose BE study in healthy subjects to exposure under chronic use conditions in patients, particularly given that phenytoin has a narrow therapeutic index. The objective of this study was to quantitatively evaluate the appropriateness of single-dose PK BE through simulations for the phenytoin extended-capsule products. Read More

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https://onlinelibrary.wiley.com/doi/abs/10.1002/jcph.1380
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http://dx.doi.org/10.1002/jcph.1380DOI Listing
February 2019
2 Reads

Development and Validation of Simple LC-MS-MS Assay for the Quantitative Determination of Ticagrelor in Human Plasma: its Application to a Bioequivalence Study.

J Chromatogr Sci 2019 Jan 31. Epub 2019 Jan 31.

Department of Pharmaceutical Biochemistry, College of Pharmacy, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, Republic of Korea.

A sensitive, rapid, reproducible and reliable high-performance liquid chromatography-electrospray ionization tandem mass spectrometric method has been developed and fully validated for the determination of ticagrelor in human plasma using ticagrelor-d7 as an internal standard (IS) after one-step liquid-liquid extraction with ethyl acetate. Ticagrelor and IS were detected in the multiple reaction monitoring mode at m/z transition 523.4 > 127. Read More

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http://dx.doi.org/10.1093/chromsci/bmz001DOI Listing
January 2019
1 Read

A Quantitative Comparison Approach for Methylphenidate Drug Regimens in Attention-Deficit/Hyperactivity Disorder Treatment.

J Child Adolesc Psychopharmacol 2019 Feb 4. Epub 2019 Feb 4.

1 Department of Pharmacy, Faculty of Pharmacy, University of Montréal , Montréal, Canada .

Objective: Different methylphenidate (MPH) formulations, immediate release (IR) or extended release (ER), have been developed to treat Attention-Deficit/Hyperactivity Disorder (ADHD). A better use of these formulations, with a proper choice of their timing, dosage, and combination, can help to attain optimal therapeutic effect while maintaining a good quality of life. In this study, we aim at presenting a quantitative comparison approach to help identify drug regimens that provide best therapeutic performances and respect patients' specific needs. Read More

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http://dx.doi.org/10.1089/cap.2018.0093DOI Listing
February 2019
1 Read
2.933 Impact Factor

Systemic Bioequivalence Is Unlikely to Equal Target Site Bioequivalence for Nanotechnology Oncologic Products.

AAPS J 2019 Feb 1;21(2):24. Epub 2019 Feb 1.

Institute of Quantitative Systems Pharmacology, 1815 Aston Avenue, suite 107, Carlsbad, California, 92008, USA.

Approval of generic drugs by the US Food and Drug Administration (FDA) requires the product to be pharmaceutically equivalent to the reference listed drug (RLD) and demonstrate bioequivalence (BE) in effectiveness when administered to patients under the conditions in the RLD product labeling. Effectiveness is determined by drug exposure at the target sites. However, since such measurement is usually unavailable, systemic exposure is assumed to equal target site exposure and systemic BE to equal target site BE. Read More

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http://dx.doi.org/10.1208/s12248-019-0296-zDOI Listing
February 2019
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A pharmacokinetic study of radiprodil oral suspension in healthy adults comparing conventional venous blood sampling with two microsampling techniques.

Pharmacol Res Perspect 2019 02 28;7(1):e00459. Epub 2019 Jan 28.

PRA Health Sciences - Early Development Services (PRA-EDS) Groningen The Netherlands.

In this phase I, single-center, open-label study of ten heathy adults (18-45 years; NCT02647697), the PK, safety, and tolerability profile of radiprodil oral suspension in healthy adults were assessed, as well as two PK microsampling techniques. All participants received a single 30 mg radiprodil dose (12 mL oral suspension). Blood was collected at various time points using conventional venous sampling (intravenous catheter or venepuncture), and Mitra™ and Aqua-Cap™ Drummond microsampling (finger-prick and blood taken from venous blood sample tubes). Read More

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http://dx.doi.org/10.1002/prp2.459DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6349788PMC
February 2019
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LC-MS/MS determination of 4-hydroxynimesulide, an active metabolite of nimesulide and application to bioequivalence study in Indian subjects.

Eur J Mass Spectrom (Chichester) 2019 Jan 29:1469066718822621. Epub 2019 Jan 29.

1 Department of Pharmaceutical Technology, Bioequivalence Study Centre, Jadavpur University, Kolkata, India.

A simple and highly sensitive bioanalytical method was developed and validated for simultaneous quantification of nimesulide (NSD) and its active metabolite 4-hydroxy-nimesulide (M1) in human plasma by liquid chromatography-tandem mass spectrometer (LC-MS/MS) and applied in a bioequivalence study performed on Indian subjects. The bioanalytical method was carried out by LC-MS/MS with celecoxib (CXB) as an internal standard (IS) using liquid-liquid extraction technique. The chromatographic separation was performed on a reversed-phase Agilent eclipse plus C18 (75 mm × 4. Read More

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http://dx.doi.org/10.1177/1469066718822621DOI Listing
January 2019
1 Read

Bioequivalence of Tenofovir Component of Tenofovir/Rilpivirine/Emtricitabine in Digital Pills.

AIDS Res Hum Retroviruses 2019 Jan 29. Epub 2019 Jan 29.

Brigham and Women's Hospital, Emergency Medicine, Boston, Massachusetts, United States.

Background: Digital pills, gelatin capsules with radiofrequency transmitters activated by stomach chloride ions, directly measure anti-retroviral therapy (ART) adherence. In individuals with substance use disorders and HIV, real-time nonadherence detected by digital pills creates a platform to deliver substance use and adherence interventions. In this study, we determined the bioequivalence of Tenofovir (TFV), administered as tenofovir disoproxil fumarate (TDF) in healthy human volunteers administered a commercial drug product and a digital pill formulation. Read More

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http://dx.doi.org/10.1089/AID.2018.0073DOI Listing
January 2019
1 Read

On the unphysical hypotheses in pharmacokinetics and oral drug absorption: Time to utilize instantaneous rate coefficients instead of rate constants.

Eur J Pharm Sci 2019 Mar 25;130:137-146. Epub 2019 Jan 25.

School of Pharmacy and Pharmaceutical Sciences, State University of New York at Buffalo, Buffalo, NY, USA; Pharma Informatics Unit, Research Center ATHENA, Athens, Greece; Department of Pharmacy, National and Kapodistrian University of Athens, Athens, Greece. Electronic address:

This work aims to explore the unphysical assumptions associated with i) the homogeneity of the well mixed compartments of pharmacokinetics and ii) the diffusion limited model of drug dissolution. To this end, we i) tested the homogeneity hypothesis using Monte Carlo simulations for a reaction and a diffusional process that take place in Euclidean and fractal media, ii) re-considered the flip-flop kinetics assuming that the absorption rate for a one-compartment model is governed by an instantaneous rate coefficient instead of a rate constant, and, iii) re-considered the extent of drug absorption as a function of dose using an in vivo reaction limited model of drug dissolution with integer and non-integer stoichiometry values. We found that drug diffusional processes and reactions are slowed down in heterogeneous media and the environmental heterogeneity leads to increased fluctuations of the measurable quantities. Read More

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http://dx.doi.org/10.1016/j.ejps.2019.01.027DOI Listing

Iberoamerican Pharmacometrics Network Congress 2018 Report: fostering M&S approaches for drug development, regulatory and clinical applications in Latin America.

CPT Pharmacometrics Syst Pharmacol 2019 Jan 25. Epub 2019 Jan 25.

Pharmacobiology Department, University Center of Exact Sciences and Engineering, University of Guadalajara, Mexico.

This report provides a brief description of the 2018 RedIF Congress that took place in Guadalajara (Mexico), on November 7-9. The meeting aimed to foster modeling & simulation approaches for drug development, regulatory sciences and clinical application in Latin America. Organizations that cosponsored the meeting were: University of Guadalajara, International Society of Pharmacometrics (ISoP), International Pharmaceutical Federation (FIP), Clinic of Chronic Diseases and Special Procedures (CECyPE), Zurich Pharma, Pharmet (Pharmometrica), Lixoft and ICON. Read More

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http://dx.doi.org/10.1002/psp4.12387DOI Listing
January 2019

PBPK Absorption Modeling: Establishing the In Vitro-In Vivo Link-Industry Perspective.

AAPS J 2019 Jan 23;21(2):19. Epub 2019 Jan 23.

Biopharmaceutics and Specialty Dosage Forms, Pharmaceutical Sciences, Merck & Co., Inc., 770 Sumneytown Pike, WP75B-210, West Point, Pennsylvania, 19486-0004, USA.

The establishment of an in vitro-in vivo correlation (IVIVC) is considered the gold standard to establish in vivo relevance of a dissolution method and to utilize dissolution data in the context of regulatory bioequivalence questions, including the development of dissolution specifications. However, several recent publications, including industry surveys and reviews from regulatory agencies, have indicated a low success rate for IVIVCs, especially for immediate-release formulations. In recent years, the use of physiologically based pharmacokinetics (PBPK) and absorption modeling, as a tool to facilitate formulation development, has been attracting increased attention. Read More

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http://dx.doi.org/10.1208/s12248-019-0292-3DOI Listing
January 2019
3 Reads

On Bayesian Analysis and Hypothesis Testing in the Determination of Bioequivalence.

Clin Pharmacol Ther 2019 Feb 21;105(2):304-306. Epub 2019 Jan 21.

Office of Biostatistics, Office of Translational Sciences/Center for Drug Evaluation and Research/US Food and Drug Administration, Silver Spring, Maryland, USA.

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http://doi.wiley.com/10.1002/cpt.1291
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http://dx.doi.org/10.1002/cpt.1291DOI Listing
February 2019
9 Reads

Bayesian Approach to Establish Bioequivalence: Why and How?

Clin Pharmacol Ther 2019 Feb 21;105(2):301-303. Epub 2019 Jan 21.

GCStat Consulting, LLC, Silver Spring, Maryland, USA.

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http://dx.doi.org/10.1002/cpt.1288DOI Listing
February 2019

A phase I, randomized, double-blinded, single-dose study evaluating the pharmacokinetic equivalence of the biosimilar IBI305 and bevacizumab in healthy male subjects
.

Int J Clin Pharmacol Ther 2019 Mar;57(3):167-174

Objective: To compare the pharmacokinetic (PK) profiles, immunogenicity, and safety of the proposed biosimilar IBI305 with those of bevacizumab in healthy male subjects.

Design: A phase I, randomized, double-blinded, two-arm, parallel-group study.

Settings: The study was conducted in The First Hospital of Jilin University, Changchun, China, from March 2017 to November 2017. Read More

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http://dx.doi.org/10.5414/CP203349DOI Listing
March 2019
10 Reads

Assessment of individual bioequivalence using sufficient bootstrap procedure.

Authors:
Ufuk Beyaztas

Pharm Stat 2019 Jan 20. Epub 2019 Jan 20.

Department of Statistics, Bartin University, Bartin, Turkey.

This paper proposes a sufficient bootstrap method, which uses only the unique observations in the resamples, to assess the individual bioequivalence under 2 × 4 randomized crossover design. The finite sample performance of the proposed method is illustrated by extensive Monte Carlo simulations as well as a real-experimental data set, and the results are compared with those obtained by the traditional bootstrap technique. Our records reveal that the proposed method is a good competitor or even better than the classical percentile bootstrap confidence limits. Read More

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http://doi.wiley.com/10.1002/pst.1930
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http://dx.doi.org/10.1002/pst.1930DOI Listing
January 2019
5 Reads

Method development and validation of ursodiol and its major metabolites in human plasma by HPLC-tandem mass spectrometry.

Clin Pharmacol 2019 4;11:1-13. Epub 2019 Jan 4.

Pharmacology Department (UNIFAG), Universidade São Francisco, Bragança Paulista, SP, Brazil,

Background: Ursodeoxycholic acid (UDCA) and its metabolites tauroursodeoxycholic acid (TUDCA) and glycoursodeoxycholic acid (GUDCA) have been the subject of several pharmacological studies. The objective of this study was to develop an innovative method of quantification by HPL-tandem mass spectrometry (LC-MS/MS), with a lower cost and suitable, for application in bioequivalence studies.

Methods: The procedure involved liquid-liquid extraction for quantification of UDCA/GUDCA and precipitation extraction for TUDCA, using deuterated substances as internal standards (ISs) and Phenomenex Luna 250×4. Read More

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http://dx.doi.org/10.2147/CPAA.S187519DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6324612PMC
January 2019

Totally laparoscopic versus open gastrectomy for advanced gastric cancer: a matched retrospective cohort study.

Hong Kong Med J 2019 Feb 18;25(1):30-7. Epub 2019 Jan 18.

Department of Surgery, Queen Elizabeth Hospital, Jordan, Hong Kong.

Introduction: Laparoscopic gastrectomy revolutionised the management of gastric cancer, yet its oncologic equivalency and safety in treating advanced gastric cancer (especially that in smaller centres) has remained controversial because of the extensive lymphadenectomy and learning curve involved. This study aimed to compare outcomes following laparoscopic versus open gastrectomy for advanced gastric cancer at a regional institution in Hong Kong.

Methods: Fifty-four patients who underwent laparoscopic gastrectomy from January 2009 to March 2017 were compared with 167 patients who underwent open gastrectomy during the same period. Read More

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https://www.hkmj.org/earlyrelease/hkmj177150.html
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http://dx.doi.org/10.12809/hkmj177150DOI Listing
February 2019
3 Reads

Batch-to-Batch and Within-Subject Variability: What Do We Know and How Do These Variabilities Affect Clinical Pharmacology and Bioequivalence?

Clin Pharmacol Ther 2019 Feb 16;105(2):326-328. Epub 2019 Jan 16.

Oriel Therapeutics, Inc., Emeryville, California, USA.

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http://dx.doi.org/10.1002/cpt.1294DOI Listing
February 2019

Evaluating Within-Subject Variability for Narrow Therapeutic Index Drugs.

Clin Pharmacol Ther 2019 Feb 16;105(2):411-416. Epub 2019 Jan 16.

Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, San Francisco, California, USA.

The US Food and Drug Administration (FDA) reference-scaled average bioequivalence approach scales the bioequivalence (BE) limits of narrow therapeutic index drugs (NTIDs) to the intrasubject or within-subject variability (WSV) of the reference-listed drug. A clinical study was conducted to evaluate the WSV of warfarin (Coumadin), 10 mg, administered to 10 healthy volunteers exhibiting similar cytochrome P450 2C9 and vitamin K epoxide reductase alleles on 3 study days. Individual intrasubject coefficients of variation for maximum plasma concentration and area under the curve (0-72 hour) ranged from 3. Read More

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http://dx.doi.org/10.1002/cpt.1293DOI Listing
February 2019
1 Read
7.903 Impact Factor

Bioequivalence of two quetiapine extended release tablets in Chinese healthy volunteers under fasting and fed conditions and effects of food on pharmacokinetic profiles.

Drug Des Devel Ther 2019 31;13:255-264. Epub 2018 Dec 31.

Department of National Drug Clinical Trial Research Center, Xiangya Boai Rehabilitation Hospital, Changsha, People's Republic of China,

Objective: The objectives of this study were to evaluate the bioequivalence of Quesero extended release (Quesero XR) tablets and Seroquel extended release (Seroquel XR) tablets under fasting and fed conditions and to determine the effect of food on the pharmacokinetic (PK) properties of Quesero XR or Seroquel XR in Chinese healthy volunteers.

Methods: A single-site, randomized, open-label, two-period crossover design with a 10-day washout period was conducted in 20 subjects under the fed and fasting studies. A single oral dose of 200 mg Quesero XR or Seroquel XR was given to the subjects after an overnight fast of 10 hours. Read More

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http://dx.doi.org/10.2147/DDDT.S182965DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6319427PMC
December 2018

A Kinetic Approach to Determining Drug Distribution in Complex Biphasic Systems.

J Pharm Sci 2019 Jan 11. Epub 2019 Jan 11.

Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20993. Electronic address:

Pharmaceutical emulsions contain multiple components, such as micellar, aqueous, and oil phases, leading to complex drug transfer and equilibrium phenomena. These complex components present challenges for the bioequivalence assessment of the drug products. The objective of the study was to develop a method that can probe the underlying mechanism and process of drug distribution. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S00223549193000
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http://dx.doi.org/10.1016/j.xphs.2019.01.003DOI Listing
January 2019
5 Reads

Swedish patients' trust in the bioequivalence of interchangeable generics. What factors are important for low trust?

Pharm Pract (Granada) 2018 Oct-Dec;16(4):1298. Epub 2018 Dec 14.

Department of Pharmacy, Unit for Social and Clinical Pharmacy, University of Copenhagen. Copenhagen (Denmark).

Background: Generic substitution (GS), is a cost-containment strategy meant to contain pharmaceutical expenditure without compromising health objectives. In order to shape GS into a policy that is both efficient and safe it is crucial to understand which factors are most important for patients' trust in GS.

Objective: To assess Swedish patients' level of trust in the bioequivalence of cheap and expensive generic medicines, and the association between trust and various factors. Read More

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http://dx.doi.org/10.18549/PharmPract.2018.04.1298DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6322990PMC
December 2018
9 Reads

Switchability of Gabapentin formulations: A randomised trial to assess bioequivalence between NEURONTIN and GABASANDOZ on the individual subject level.

Clin Pharmacol Ther 2019 Jan 13. Epub 2019 Jan 13.

Laboratory of Medical Biochemistry and Clinical Analysis, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium.

Generic substitution of anti-epileptic drugs is generally not advised by neurologists. The present study investigated the switchability of gabapentin 800mg tablets (NEURONTIN and GABASANDOZ ) using an individual bioequivalence (IBE) study design with 2 batches of each product, and assessed whether between-batch and between-formulation variability in exposure play a significant role in the within-subject variability. The trial was analysed according to the Food and Drug Administration framework to establish IBE. Read More

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http://dx.doi.org/10.1002/cpt.1353DOI Listing
January 2019
1 Read

An Open-Label, Randomized, Pivotal Bioequivalence Study of Oral Rolapitant.

Clin Pharmacol Drug Dev 2019 Feb 9;8(2):152-159. Epub 2019 Jan 9.

TESARO, Inc., Waltham, MA, USA.

Rolapitant, a selective and long-acting neurokinin-1 receptor antagonist, is approved in an oral formulation for prevention of delayed chemotherapy-induced nausea and vomiting in adults. This pivotal open-label, randomized, single-dose, multicenter, parallel-group study assessed the bioequivalence of a single oral dose of 180 mg of rolapitant administered in tablet (2 × 90-mg tablets) or capsule (4 × 45-mg capsules) form in healthy male and female subjects. Blood samples for pharmacokinetic analysis were collected predose and at times up to 912 hours postdose. Read More

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http://doi.wiley.com/10.1002/cpdd.651
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http://dx.doi.org/10.1002/cpdd.651DOI Listing
February 2019
14 Reads

PBPK Absorption Modeling of Food Effect and Bioequivalence in Fed State for Two Formulations with Crystalline and Amorphous Forms of BCS 2 Class Drug in Generic Drug Development.

AAPS PharmSciTech 2019 Jan 8;20(2):59. Epub 2019 Jan 8.

Faculty of Pharmacy, University of Ljubljana, Aškerčeva cesta 7, 1000, Ljubljana, Slovenia.

Prediction of the effect of food on drug's pharmacokinetics using modeling and simulation could cause difficulties due to complex in vivo processes. A generic formulation with amorphous form of BCS 2 class drug substance was developed and compared in vitro and in vivo to the reference drug product with drug substance in crystalline form. In order to approve generic formulation, some regulatory agencies are requesting to perform bioequivalence (BE) studies also in fed state. Read More

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http://link.springer.com/10.1208/s12249-018-1285-8
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http://dx.doi.org/10.1208/s12249-018-1285-8DOI Listing
January 2019
6 Reads

From bioequivalence to biosimilars: How much do regulators dare?

Authors:
Martina Weise

Z Evid Fortbild Qual Gesundhwes 2019 Jan 6. Epub 2019 Jan 6.

Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn, Germany. Electronic address:

The main advantage of an abbreviated licensing pathway is the possibility of extrapolating efficacy and safety data from an original medicinal product to a subsequent "copy" version, thereby reducing the clinical development programme in particular. For small-molecule chemically synthesized generics, such an abbreviated licensing pathway was established decades ago, whereas it was only more recently implemented for similar biological medicinal products, so-called biosimilars. Clinicians and patients have repeatedly expressed concerns about the efficacy and safety of biosimilars, especially in 'extrapolated' indications for which no own clinical data have been generated. Read More

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http://dx.doi.org/10.1016/j.zefq.2018.12.001DOI Listing
January 2019
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Three-dimensional (3-D) printing technology exploited for the fabrication of drug delivery systems.

Curr Pharm Des 2018 Dec 31. Epub 2018 Dec 31.

School of Pharmacy, Faculty of Health and Medical Science, Taylor's University, Selangor-47500. Malaysia.

Background: The conventional dosage forms cannot be administered to all patients because of inter-individual variability found among people of different race coupled with different metabolism and cultural necessities. Therefore, to address this global issue there is a growing focus on the development of novel drug delivery systems customised to individual needs. Three-dimensional (3-D) printed medicines are transforming the current pharmaceutical market as a potential alternative to conventional medicine. Read More

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http://www.eurekaselect.com/168677/article
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http://dx.doi.org/10.2174/1381612825666190101111525DOI Listing
December 2018
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Scientific Considerations for the Review and Approval of First Generic Mometasone Furoate Nasal Suspension Spray in the United States from the Bioequivalence Perspective.

AAPS J 2019 Jan 7;21(2):14. Epub 2019 Jan 7.

Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

In 2016, the US Food and Drug Administration (FDA) approved the first Abbreviated New Drug Application for Mometasone Furoate Nasal Suspension Spray. To establish the bioequivalence of this generic nasal suspension spray with the reference listed drug product (RLD), Nasonex®, a "weight-of-evidence" approach was utilized by the applicant that included formulation and device similarities, equivalent in vitro performance, equivalent systemic exposure, and equivalent local delivery. In addition to these testing for comprehensive evaluation of the drug product, FDA also considered supportive data generated by a novel in vitro method, Morphologically-Directed Raman Spectroscopy (MDRS), to characterize the particle size distribution (PSD) of active pharmaceutical ingredient (API) in the drug product. Read More

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http://link.springer.com/10.1208/s12248-018-0283-9
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http://dx.doi.org/10.1208/s12248-018-0283-9DOI Listing
January 2019
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A Novel Simulation-Based Approach for Comparing the Population Against Average Bioequivalence Statistical Test for the Evaluation of Nasal Spray Products on Spray Pattern and Droplet Size Distribution Parameters.

AAPS PharmSciTech 2019 Jan 2;20(1):38. Epub 2019 Jan 2.

Faculty of Pharmacy, University of Ljubljana, Aškerčeva cesta 7, 1000, Ljubljana, Slovenia.

The aim of this work is to evaluate average bioequivalence (ABE) and population bioequivalence (PBE) statistical approaches so as to identify which approach is most suitable for in vitro bioequivalence (IVBE) testing of nasal spray products. For droplet size distribution (DSD) and spray pattern (SP), in vitro data were collected using a well-established nasal spray on the market (Nasonex®, manufactured by Merck Sharp & Dohme Limited). Simulations were performed using in vitro data to comparatively investigate ABE and PBE tests. Read More

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http://dx.doi.org/10.1208/s12249-018-1223-9DOI Listing
January 2019
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UPLC-MS metabolome based classification of Lupinus and Lens seeds: A prospect for phyto-equivalency of its different accessions.

Food Res Int 2019 Jan 4;115:379-392. Epub 2018 Nov 4.

Department for Bioarchaeology, Austrian Archaeological Institute (ÖAI), Austrian Academy of Sciences (ÖAW), Austria.

Fabaceae is well-known for its seed nutritious and bioactive composition as exemplified by Lupinus and Lens. Developing efficient analytical approaches for profiling their bioactive matrix is a prerequisite to provide proof for their health benefits or nutritive traits. Eight Lupinus and Lens seed accessions were subjected to liquid chromatography-mass spectrometry (UPLC-MS)-based metabolomic study, which identified 66 metabolites, viz. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S09639969183088
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http://dx.doi.org/10.1016/j.foodres.2018.11.003DOI Listing
January 2019
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A Survey of the Regulatory Requirements for the Acceptance of Foreign Comparator Products by Participating Regulators and Organizations of the International Generic Drug Regulators Programme.

J Pharm Pharm Sci 2019 ;22(1):28-36

Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), C/ Campezo 1. Edificio 8. Madrid, 28022, Spain.

The acceptance of foreign comparator products is the most limiting factor for the development and regulatory assessment of generic medicines marketed globally. Bioequivalence studies have to be repeated with the local comparator products of each jurisdiction because it is unknown if the comparators of the different countries are the same product, with the consequent duplication of efforts by regulators and industry alike. The regulatory requirements on the acceptability of foreign comparator products of oral dosage forms differ between countries participating in the Bioequivalence Working Group for Generics of the International Pharmaceutical Regulators Programme. Read More

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http://dx.doi.org/10.18433/jpps30215DOI Listing
January 2019
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A Phase I, Randomized, Crossover, Open-Label Study of the Pharmacokinetics of Solriamfetol (JZP-110) in Healthy Adult Subjects With and Without Food.

Clin Ther 2018 Dec 28. Epub 2018 Dec 28.

Jazz Pharmaceuticals, Palo Alto, CA, United States.

Purpose: Solriamfetol (JZP-110), a selective dopamine and norepinephrine reuptake inhibitor with robust wake-promoting effects, is currently being evaluated for the reduction of sleepiness and improvement of wakefulness in patients with narcolepsy and obstructive sleep apnea. The purpose of this study was to evaluate the effect of food on the pharmacokinetic (PK) parameters and bioavailability of solriamfetol at the highest intended therapeutic dose in healthy adults and to characterize its renal excretion under fasting conditions.

Methods: In this open-label, randomized, crossover study, healthy adult subjects received a single 300-mg dose of solriamfetol in a fasted condition (10 h) and in a fed condition (30 min after the start of a standardized high-fat, high-calorie breakfast), with at least a 7-day washout period between doses. Read More

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http://dx.doi.org/10.1016/j.clinthera.2018.12.001DOI Listing
December 2018
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Highly sensitive LC-MS/MS method to estimate doxepin and its metabolite nordoxepin in human plasma for a bioequivalence study.

J Pharm Anal 2018 Dec 16;8(6):378-385. Epub 2017 Jun 16.

Bio-Analytical Laboratory, Cliantha Research India Ltd., Bodakdev, Ahmedabad 380054, Gujarat, India.

A selective, sensitive and rugged liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay has been developed for the simultaneous determination of doxepin (Dox) and its pharmacologically active metabolite, nordoxepin (NDox) in human plasma. The analytes and their internal standards (IS) were extracted from 500 µL of human plasma by liquid-liquid extraction using methyl -butyl ether. Chromatographic separation was achieved on Hypurity C column (100 mm × 4. Read More

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http://dx.doi.org/10.1016/j.jpha.2017.06.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6308917PMC
December 2018
7 Reads

Development of multi-criteria decision analysis (MCDA) framework for off-patent pharmaceuticals - an application on improving tender decision making in Indonesia.

BMC Health Serv Res 2018 Dec 29;18(1):1003. Epub 2018 Dec 29.

Syreon Research Institute, Mexikói str. 65/A, Budapest, 1142, Hungary.

Background: Off-patent pharmaceuticals (OPPs) hold vital importance in meeting public health objectives, especially in developing countries where resources are limited. OPPs are comprised of off-patent originals, branded generics and unbranded generics; nonetheless, these products are not identical and often there are differences in their equivalence, manufacturing quality standards and reliability of supply. This necessitates reconsideration of the lowest price policy objective in pharmaceutical decision making. Read More

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http://dx.doi.org/10.1186/s12913-018-3805-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6310978PMC
December 2018
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Scalable Production of AAV Vectors in Orbitally Shaken HEK293 Cells.

Mol Ther Methods Clin Dev 2019 Jun 22;13:14-26. Epub 2018 Nov 22.

Department of Clinical Neurosciences, Laboratory of Neurotherapies and Neuromodulation (LNTM), Lausanne University Hospital (CHUV), 1011 Lausanne, Switzerland.

Adeno-associated virus (AAV) vectors are currently among the most commonly applied for gene therapy approaches. The evaluation of vectors during clinical development requires the production of considerable amounts of highly pure and potent vectors. Here, we set up a scalable process for AAV production, using orbitally shaken bioreactors and a fully characterized suspension-adapted cell line, HEKExpress. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S23290501183011
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http://dx.doi.org/10.1016/j.omtm.2018.11.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6305802PMC
June 2019
4 Reads

Investigation of the properties of the "switching decision rule" described in the Japanese guideline for human bioequivalence studies.

Authors:
Yoichi Ii

Pharm Stat 2018 Dec 26. Epub 2018 Dec 26.

Pfizer Japan, Inc., Tokyo, Japan.

In a human bioequivalence (BE) study, the conclusion of BE is usually based on the ratio of geometric means of pharmacokinetic parameters between a test and a reference products. The "Guideline for Bioequivalence Studies of Generic Products" (2012) issued by the Japanese health authority and other similar guidelines across the world require a 90% confidence interval (CI) of the ratio to fall entirely within the range of 0.8 to 1. Read More

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http://dx.doi.org/10.1002/pst.1922DOI Listing
December 2018
1 Read

Development and validation of liquidchromatographic method for quantitative determination of Loxoprofen in mobilephase and in human plasma.

Pak J Pharm Sci 2018 Nov;31(6 (Supplementary):2629-2633

Faculty of Pharmacy, Federal Urdu University of Arts, Science and Technology, Karachi, Pakistan.

A Simple, sensitive and accurate high-performance liquid chromatographic (HPLC) method for effective and specific analysis of Loxoprofen (LXP) in the mobilephase and human plasma was developed. Effective chromatographic separation was attained on a Mediterranean Sea C18 column (250×4.6mm, 5um) with mobilephase containing acetonitrile and 0. Read More

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November 2018
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Bioavailability of α-tocopherol stereoisomers in lambs depends on dietary doses of all-rac- or RRR-α-tocopheryl acetate.

Animal 2018 Dec 27:1-9. Epub 2018 Dec 27.

1Trouw Nutrition Research and Development,P.O. Box 299,Amersfoort3800-AG,The Netherlands.

When supplementing lamb diets with vitamin E, an equivalence factor of 1.36 is used to discriminate between RRR-α-tocopheryl acetate and all-rac-α-tocopheryl acetate. However, more recent studies suggest a need for new equivalence factors for livestock animals. Read More

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http://dx.doi.org/10.1017/S1751731118003373DOI Listing
December 2018

Genotype-based enrichment study design for minimizing the sample size in bioequivalence studies using tolterodine and CYP2D6 genotype
.

Int J Clin Pharmacol Ther 2019 Feb;57(2):110-116

Objective: The objective of this study was to explore a pharmacogenomic information-based enrichment study design for reducing the sample size in bioequivalence (BE) studies using tolterodine and CYP2D6 genotypes.

Materials And Methods: A BE study of tolterodine was performed in a randomized, open-label, 2×2 cross-over design. A two one-sided test (TOST) was executed for pharmacokinetic (PK) parameters of tolterodine, and their geometric mean ratios (GMRs) with 90% confidence intervals (CIs) were estimated. Read More

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http://dx.doi.org/10.5414/CP203297DOI Listing
February 2019

Pharmacokinetic comparison of gemigliptin 50 mg and metformin 500 mg as a fixed-dose combination and loose combination
.

Int J Clin Pharmacol Ther 2019 Feb;57(2):117-124

Background: Metformin and dipeptidyl peptidase-4 (DPP-IV) inhibitors are commonly combined to treat patients with diabetes mellitus (DM). A new fixed-dose combination (FDC) drug containing gemigliptin, a DPP-IV inhibitor, and sustained-release metformin has been developed. This study aimed to compare the PKs and tolerability of FDC versus loose combination of gemigliptin 50 mg and metformin 500 mg. Read More

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http://dx.doi.org/10.5414/CP203289DOI Listing
February 2019

Bioequivalence studies with anti-TNF biosimilars.

Expert Opin Biol Ther 2018 Dec 21. Epub 2018 Dec 21.

c Departamento de Medicina, Facultad de Medicina. Digestive Diseases Service . Hospital Clínico Universitario "Lozano Blesa" ; IIS Aragón; CIBEREHD , Zaragoza , Spain .

Introduction: Biosimilars, as defined by the European Medicines Agency, have been used in Europe since 2006. The landscape was considerably expanded when the first biosimilar of a monoclonal was approved and introduced in the European market. CT-P13 was developed by Celltrion as an infliximab biosimilar in 2013, not without controversy. Read More

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https://www.tandfonline.com/doi/full/10.1080/14712598.2019.1
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http://dx.doi.org/10.1080/14712598.2019.1561851DOI Listing
December 2018
4 Reads