8,658 results match your criteria Journal of Bioequivalence & Bioavailability [Journal]


A critical review of HPLC-based analytical methods for quantification of Linezolid.

Crit Rev Anal Chem 2019 Apr 24:1-16. Epub 2019 Apr 24.

a Institute of Chemistry, São Paulo State University , Araraquara , Brazil.

Linezolid is a synthetic antimicrobial agent belonging to the oxazolidinone class. Since its approval in the year 2000 until now, linezolid remains the main representative drug for the oxazolidinone class of drugs, which is used in therapy due to its unique mode of action, which involves inhibition of protein synthesis. As linezolid holds great importance in antimicrobial therapy, it is necessary to compile the various analytical methods that have been reported in the literature for its analysis. Read More

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http://dx.doi.org/10.1080/10408347.2019.1605876DOI Listing

Comparative Toxicity Study of Docetaxel and Nanoxel, a Docetaxel-Loaded Micellar Formulation Using Cultured and Blood Cells.

Toxicol Res 2019 Apr 15;35(2):201-207. Epub 2019 Apr 15.

College of Pharmacy, Dongguk University, Goyang, Korea.

Nanoxel-PM (Nanoxel) is a docetaxel-loaded methoxy-poly(ethylene glycol)--poly(D,L-lactide) (mPEG-PDLLA). This newly developed and marketed nanoformulation exhibits an improved pharmacokinetic profile, efficacy, and safety. Although the safety of Nanoxel to docetaxel as well as its bioequivalence must be clinically confirmed, all biological activities have not been examined in or studies. Read More

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http://dx.doi.org/10.5487/TR.2019.35.2.201DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6467357PMC

The Association of Tacrolimus Formulation Switching with Trough Concentration Variability: A Retrospective Cohort Study of Tacrolimus Use Post-Kidney Transplantation Based on National Drug Code (NDC) Numbers.

Adv Ther 2019 Apr 19. Epub 2019 Apr 19.

Formerly Real World Evidence, CTI Clinical Trial and Consulting Services, Raleigh, NC, USA.

Introduction: It was hypothesized that patients experiencing at least one tacrolimus formulation switch may require more frequent therapeutic drug monitoring, subsequent dose adjustments, and a potential for untoward clinical outcomes than patients who remain on a single formulation.

Methods: Eligible patients were adult kidney transplant recipients with stable renal function at month 3 post-transplant and no evidence of acute rejection, receiving an oral, tacrolimus-based regimen. Patients were categorized into two groups (fixed or variable formulation) using the US National Drug Code (NDC) on the basis of tacrolimus formulation usage over the 12-month period. Read More

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http://dx.doi.org/10.1007/s12325-019-00950-5DOI Listing
April 2019
1 Read

Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for Bioanalysis.

Bioanalysis 2019 Apr 17. Epub 2019 Apr 17.

WuXi Apptec, Plainsboro, NJ, USA.

Over the last decade, the use of biomarker data has become integral to drug development. Biomarkers are not only utilized for internal decision-making by sponsors; they are increasingly utilized to make critical decisions for drug safety and efficacy. As the regulatory agencies are routinely making decisions based on biomarker data, there has been significant scrutiny on the validation of biomarker methods. Read More

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http://dx.doi.org/10.4155/bio-2019-0072DOI Listing
April 2019
3.003 Impact Factor

Development and optimization of a supercritical fluid chromatography tandem mass spectrometry method for the high-throughput determination of nimodipine in beagle plasma.

J Sep Sci 2019 Apr 17. Epub 2019 Apr 17.

Wuya College of Innovation, School of Pharmacy, Shenyang Pharmaceutical University, No. 103, Wenhua Road, Shenyang, 110016, PR China.

A simple, sensitive and efficient supercritical fluid chromatography tandem mass spectrometry method was established for the determination of nimodipine in beagle plasma. One-step protein precipitation with acetone was used to extract the analytes from the plasma. Nitrendipine was used as the internal standard. Read More

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http://dx.doi.org/10.1002/jssc.201900134DOI Listing
April 2019
1 Read

Quick and Sensitive UPLC-ESI-MS/MS Method for Simultaneous Estimation of Sofosbuvir and Its Metabolite in Human Plasma.

Molecules 2019 Apr 3;24(7). Epub 2019 Apr 3.

Pharmaceutical and Medicinal Chemistry Department, Pharmaceutical and Drug Industries Research Division, National Research Centre, P.O. Box 12622, Dokki, Giza, Egypt.

A simple, fast and highly sensitive RP-UPLC-MS/MS method was developed and validated for the simultaneous determination of sofosbuvir (SR) and its metabolite GS331007 in human plasma using ketotifen as an internal standard (IS). The separation was achieved on Acquity UPLC BEH C (50 × 2.1 mm, i. Read More

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http://dx.doi.org/10.3390/molecules24071302DOI Listing

Levodopa-carbidopa intestinal gel high concentration formulation is clinically bioequivalent to commercial formulation.

Pharmacol Res Perspect 2019 Apr;7(2):e00473

AbbVie Inc., North Chicago, llinois.

A new levodopa-carbidopa intestinal gel (LCIG) system featuring a higher levodopa/carbidopa (LD/CD) concentration and viscosity, LCIG-HV, is being developed to reduce the intrajejunal volume of LD/CD that is administered as compared to the current commercial formulation, LCIG-LV. This study characterizes the LCIG-HV formulation and compares it to the LCIG-LV formulation via dissolution testing and a clinical pharmacokinetic bioequivalence study. In vitro release profiles of LD/CD were determined using a USP Dissolution Apparatus 2 with 500 mL of phosphate buffer (pH 4. Read More

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http://dx.doi.org/10.1002/prp2.473DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6452870PMC
April 2019
1 Read

Analytical Challenges of Spray Pattern Method Development for Purposes of In Vitro Bioequivalence Testing in the Case of a Nasal Spray Product.

J Aerosol Med Pulm Drug Deliv 2019 Apr 8. Epub 2019 Apr 8.

1 Faculty of Pharmacy, University of Ljubljana, Ljubljana, Slovenia.

Background: A spray pattern (SP) test is one of the most challenging in vitro tests for nasal spray products (NSPs) associated with a high degree of variation. The total results variation observed in such studies should be in major part representative of product performance to assure high confidence when making conclusions based on obtained results. Analytical methods should be developed in a way to minimize variation contribution of random factors. Read More

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http://dx.doi.org/10.1089/jamp.2018.1473DOI Listing
April 2019
1 Read

Ocular biopharmaceutics: impact of modeling and simulation on topical ophthalmic formulation development.

Drug Discov Today 2019 Apr 5. Epub 2019 Apr 5.

Early Pharmaceutical Development, Allergan plc, 2525 Dupont Drive, Irvine, CA, 92612, United States.

The estimation of ocular pharmacokinetics (PK) in various eye tissues is limited because of sampling challenges. Computational modeling and simulation tools underpinning the elucidation of drug access routes and prediction of ocular exposure are essential for the mechanistic assessment of biopharmaceutics in the eye. Therefore, theoretical and experimental evaluation of ocular absorption and transit models is necessary. Read More

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http://dx.doi.org/10.1016/j.drudis.2019.04.002DOI Listing
April 2019
1 Read

Population Pharmacokinetics of Clozapine and Norclozapine and Switchability Assessment between Brands in Uruguayan Patients with Schizophrenia.

Biomed Res Int 2019 6;2019:3163502. Epub 2019 Mar 6.

C Pediatrics Clinics, Pereira Rossell Hospital, Bulevar Gral. Artigas 1550, 11600 Montevideo, Faculty of Medicine, Universidad de la República, Uruguay.

Clozapine (CZP) is an atypical antipsychotic agent commonly used in the treatment of schizophrenia. It is metabolized primarily by CYP1A2 enzyme, yielding a pharmacologically active metabolite, norclozapine (NCZP). Significant intra- and interindividual pharmacokinetic (PK) variability for CZP and NCZP has been observed in routine therapeutic drug monitoring. Read More

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http://dx.doi.org/10.1155/2019/3163502DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6431368PMC

Emergency treatment of adrenal crisis with prednisone suppositories: a bioequivalence study in female patients with Addison's disease.

Endocr Connect 2019 Apr;8(4):425-434

Endocrinology and Diabetes Unit, Department of Medicine I, University Hospital Wuerzburg, Wuerzburg, Germany.

Objective Patients with adrenal insufficiency (AI) need to adapt their glucocorticoid replacement under stressful conditions to prevent adrenal crisis (AC). Prednisone (PN) suppositories are used for emergency treatment. Pharmacokinetics of 100 mg PN suppositories after vaginal or rectal administration was evaluated. Read More

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http://dx.doi.org/10.1530/EC-19-0024DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6454300PMC
April 2019
6 Reads

In vitro modulation of cytochrome P450 isozymes and pharmacokinetics of caffeine by extracts of Hibiscus sabdariffa Linn calyx.

J Basic Clin Physiol Pharmacol 2019 Apr 5. Epub 2019 Apr 5.

Department of Clinical Pharmacy and Pharmacy Administration, Faculty of Pharmacy, University of Ibadan, Ibadan, Nigeria.

Background Hibiscus sabdariffa beverage (HSB) is widely consumed as a medicinal herb and sometimes used concomitantly with drugs. This study evaluated the in vitro inhibitory potential of the aqueous extract of H. sabdariffa calyces (AEHS) on selected cytochrome P450 (CYP) isozymes and the effect of HSB on the pharmacokinetics of caffeine in vivo. Read More

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http://dx.doi.org/10.1515/jbcpp-2018-0206DOI Listing
April 2019
1 Read

Levothyrox New and Old Formulations: Are they Switchable for Millions of Patients?

Clin Pharmacokinet 2019 Apr 4. Epub 2019 Apr 4.

INTHERES, Université de Toulouse, INRA, ENVT, Toulouse, France.

In France, more than 2.5 million patients are currently treated with levothyroxine, mainly as the marketed product Levothyrox. In March 2017, at the request of French authorities, a new formulation of Levothyrox was licensed, with the objective of avoiding stability deficiencies of the old formulation. Read More

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http://dx.doi.org/10.1007/s40262-019-00747-3DOI Listing
April 2019
2 Reads

Pharmacokinetics and tolerability of lefamulin following intravenous and oral dosing.

J Antimicrob Chemother 2019 Apr;74(Supplement_3):iii19-iii26

Nabriva Therapeutics US, Inc., King of Prussia, PA, USA.

Objectives: To explore the pharmacokinetics (PK) of oral and intravenous (iv) lefamulin after single and multiple doses, and the effect of food on bioavailability.

Methods: Lefamulin PK was examined in four studies. In Study 1, PK was assessed in patients with acute bacterial skin and skin structure infections who received repeated iv lefamulin q12h (150 mg). Read More

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http://dx.doi.org/10.1093/jac/dkz087DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6449572PMC
April 2019
1 Read

Nanoliposomes of supercritical carbon dioxide extract of small cardamom seeds redresses type 2 diabetes and hypercholesterolemia.

Recent Pat Biotechnol 2019 Apr 3. Epub 2019 Apr 3.

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

Background & Objectives: In our previous investigation, oral administration of 1,8-cineole-rich supercritical carbon dioxide extract of small cardamom seeds in Wistar albino rats resulted in normal fasting blood glucose levels. The objective of the current study was to further protect the aforesaid extract and to enhance its in vivo therapeutic efficacy in redressing type 2 diabetes and hypercholesterolemia, by encapsulating it as nanoliposomes. Patents related to nanoliposomes have been revised thoroughly. Read More

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http://dx.doi.org/10.2174/1872208313666190404101336DOI Listing
April 2019
1 Read

The impact of patients' real-life environmental temperature and humidity use conditions of tiotropium dry powder inhaler on its aerosol emission characteristics.

Eur J Pharm Sci 2019 May 1;133:137-144. Epub 2019 Apr 1.

ACDIMA Centre for Bioequivalence and Pharmaceutical Studies, Jordan.

Introduction: Many factors can affect dry powder inhalers' (DPIs) aerosol emission and lung deposition. The fluctuation of environmental temperature and relative humidity (RH) that inhalers experience in realistic daily use has not been extensively evaluated. This work aimed to evaluate the delivered dose (DD) and aerodynamic particle size distribution (APSD) of tiotropium Handihaler DPI (H) after exposure to patients' real-life use environments. Read More

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http://dx.doi.org/10.1016/j.ejps.2019.04.002DOI Listing
May 2019
1 Read

Trial Design and Statistical Considerations on the Assessment of Pharmacodynamic Similarity.

AAPS J 2019 Apr 3;21(3):47. Epub 2019 Apr 3.

Janssen Research & Development Inc, Spring House, PA, USA.

Pharmacodynamics (PD) similarity is an important component to support the claim of similarity between two drugs or devices. This article investigates the trial design and statistical considerations in the equivalence test of PD endpoints. Using bone resorption marker CTX as a case study, the relationship between the PD readouts and drug potency was explored to evaluate the sensitivity of the PD endpoint and guide equivalence margin selection. Read More

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http://dx.doi.org/10.1208/s12248-019-0321-2DOI Listing
April 2019
1 Read

Manufacturing of primed mesenchymal stromal cells for therapy.

Nat Biomed Eng 2019 Feb 28;3(2):90-104. Epub 2019 Jan 28.

Roy J. Carver Department of Biomedical Engineering, Fraternal Order of Eagles Diabetes Research Center, The University of Iowa, Iowa City, IA, USA.

Mesenchymal stromal cells (MSCs) for basic research and clinical applications are manufactured and developed as unique cell products by many different manufacturers and laboratories, often under different conditions. The lack of standardization of MSC identity has limited consensus around which MSC properties are relevant for specific outcomes. In this Review, we examine how the choice of media, cell source, culture environment and storage affects the phenotype and clinical utility of MSC-based products, and discuss the techniques better suited to prime MSCs with specific phenotypes of interest and the need for the continued development of standardized assays that provide quality assurance for clinical-grade MSCs. Read More

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http://dx.doi.org/10.1038/s41551-018-0325-8DOI Listing
February 2019
1 Read

Determination of terbinafine in human plasma using UPLC-MS/MS: Application to a bioequivalence study in healthy subjects.

Biomed Chromatogr 2019 Apr 1:e4543. Epub 2019 Apr 1.

Bioanalytical Department, Alkem Laboratories Ltd, Mumbai, India.

A high throughput and sensitive ultra performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method has been developed for the determination of terbinafine in human plasma. The method employed liquid-liquid extraction of terbinafine and terbinafine-d7 (used as internal standard) from 100 μL human plasma with ethyl acetate: n-hexane (80: 20, v/v) solvent mixture. Chromatography was performed on BEH C18 (50 × 2. Read More

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http://dx.doi.org/10.1002/bmc.4543DOI Listing

Panos Macheras: a pioneering scientist in pharmaceutical science.

J Pharmacokinet Pharmacodyn 2019 Mar 28. Epub 2019 Mar 28.

School of Pharmacy and Pharmaceutical Sciences, Computational and Data Enabled Science and Engineering Program, State University of New York at Buffalo, Buffalo, NY, USA.

Professor Panos Macheras is a pioneering scientist in pharmacokinetics, pharmacodynamics and biopharmaceutics. His many important contributions to pharmaceutical science are reviewed. Read More

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http://link.springer.com/10.1007/s10928-019-09628-5
Publisher Site
http://dx.doi.org/10.1007/s10928-019-09628-5DOI Listing
March 2019
3 Reads

Pharmacokinetics of a New Pharmaceutical Form of Vitamin D3 100,000 IU in Soft Capsule.

Nutrients 2019 Mar 26;11(3). Epub 2019 Mar 26.

EA 7517, Centre de Recherche Universitaire en Santé de l'UPJV, site Hôpital Sud, 80 054 Amiens, France.

Vitamin D deficiency is frequent in the general population and both subjects and health professionals could benefit from a broader range of vitamin D3 formulations. We conducted a single-dose, open-label, parallel-group, randomized bioequivalence study to compare a single dose of a newly developed vitamin D3 100,000 IU in a soft capsule (Group 1) with the reference drug vitamin D3 100,000 IU oral solution in ampoule (Group 2) in healthy volunteers over a four-month period. The primary endpoint was the area under the curve (AUC) of serum 25-hydroxyvitamin-D (25(OH)D) concentrations on Day 112. Read More

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http://dx.doi.org/10.3390/nu11030703DOI Listing

Evaluation of the effects of a generic substitution policy implemented in Chile.

BMJ Glob Health 2017 4;2(Suppl 3):e000922. Epub 2019 Mar 4.

Health Division, OECD, Paris, Île-de-France, France.

Introduction: Chile implemented a generic substitution policy in 2014 to improve access to medicines. This study aims to measure if the generic substitution policy had an effect on the sales volume and prices of referent and the branded generic products with demonstrated bioequivalence (BEQ) in the private pharmaceutical market.

Methods: The volume and total private sales of medicines sold at private sector retail outlets between November 2011 and October 2016 were considered in the analysis. Read More

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http://dx.doi.org/10.1136/bmjgh-2018-000922DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6407566PMC

The search for biosimilars and biobetters.

Drug Discov Today 2019 Mar 16. Epub 2019 Mar 16.

Covance Labs, Harrogate, England, UK.

There has been an increasing trend toward the approval of biosimilars in the USA and the EU. The regulatory requirements for demonstration of bioequivalence with comparator and reference products are now better understood. The original goal of legislation to approve biosimilars through a fast-track process that would lead to more competition and price reductions is starting to be realized. Read More

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http://dx.doi.org/10.1016/j.drudis.2019.03.016DOI Listing

Exploring Bioequivalence of Dexketoprofen Trometamol Drug Products with the Gastrointestinal Simulator (GIS) and Precipitation Pathways Analyses.

Pharmaceutics 2019 Mar 15;11(3). Epub 2019 Mar 15.

Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI 48109, USA.

The present work aimed to explain the differences in oral performance in fasted humans who were categorized into groups based on the three different drug product formulations of dexketoprofen trometamol (DKT) salt-Using a combination of in vitro techniques and pharmacokinetic analysis. The non-bioequivalence (non-BE) tablet group achieved higher plasma C and area under the curve (AUC) than the reference and BE tablets groups, with only one difference in tablet composition, which was the presence of calcium monohydrogen phosphate, an alkalinizing excipient, in the tablet core of the non-BE formulation. Concentration profiles determined using a gastrointestinal simulator (GIS) apparatus designed with 0. Read More

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http://dx.doi.org/10.3390/pharmaceutics11030122DOI Listing

Reference Pricing in Germany: Implications for U.S. Pharmaceutical Purchasing.

Issue Brief (Commonw Fund) 2019 Feb 1;2019:1-8. Epub 2019 Feb 1.

German Managed Care Association.

Issue: The German health care system resembles that of the United States in important ways — it is financed by multiple private payers and relies principally on negotiation rather than regulation to establish prices. New drugs that offer minimal benefits compared with existing alternatives within a therapeutic class are subject to reference pricing; those with incremental benefits are subject to price negotiations. Together, the reference and negotiated pricing systems have held German prices substantially below U. Read More

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February 2019
1 Read

81 Bioequivalence of a Manipulation-Resistant Immediate-Release Amphetamine Sulfate Formulation Compared with Reference Standard.

CNS Spectr 2019 Feb;24(1):216

2Director of Clinical Development,Arbor Pharmaceuticals,LLC,Atlanta,GA,USA.

Study ObjectivesWe compared the bioavailability of racemic amphetamine (d-amphetamine and l-amphetamine) from a manipulation-resistant immediate-release (IR) amphetamine sulfate capsule (AR19) versus amphetamine sulfate IR tablets (reference).

Method: In this open-label, randomized, two-period, two-treatment, two-sequence, crossover study, 36 healthy volunteers aged 18-45 received a single dose (20-mg capsule) of AR19 in one period and a single dose (2 x 10-mg tablets) of reference in another period, after a 10-hour overnight fast. Each drug administration was separated by a washout period of at least 6days. Read More

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http://dx.doi.org/10.1017/S1092852919000609DOI Listing
February 2019
2 Reads

Iron Oxide Nanoparticle Formulations for Supplementation.

Authors:
Amy Barton Pai

Met Ions Life Sci 2019 Jan;19

Intravenous (IV) iron is widely used to provide supplementation when oral iron is ineffective or not tolerated. All commercially available intravenous iron formulations are comprised of iron oxyhydroxide cores coated with carbohydrates of varying structure and branch characteristics. The diameter of the iron-carbohydrate complexes ranges from 5-100 nm and meets criteria for nanoparticles. Read More

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http://dx.doi.org/10.1515/9783110527872-012DOI Listing
January 2019
1 Read

A Randomized, Double-Blind Trial Comparing the Pharmacokinetics of CT-P16, a Candidate Bevacizumab Biosimilar, with its Reference Product in Healthy Adult Males.

BioDrugs 2019 Apr;33(2):173-181

Inje University and Inje University Busan Paik Hospital, Busan, Republic of Korea.

Background: CT-P16 is a candidate biosimilar of bevacizumab, a monoclonal antibody targeting vascular endothelial growth factor that is used in the treatment of a range of advanced solid cancers.

Objective: The objective of this study was to demonstrate the pharmacokinetic equivalence of CT-P16 and European Union (EU)-approved bevacizumab (EU-bevacizumab) and US-licensed bevacizumab (US-bevacizumab) reference products.

Methods: In this double-blind, parallel-group phase I trial (ClinicalTrials. Read More

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http://dx.doi.org/10.1007/s40259-019-00340-xDOI Listing
April 2019
1 Read

A new hypothesis to investigate bioequivalence of pharmaceutical inhalation products.

Daru 2019 Mar 7. Epub 2019 Mar 7.

Pharmaceutical Analysis Research Center and Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.

Background: This short communication reports a new hypothesis regarding bioequivalence of inhalation products which can potentially provide a reliable means to compare pharmaceutical aerosol formulations and inhalers.

Methods: Available methods regarding the bioequivalence studies, inhaled drugs and advantages of exhaled breath condensate (EBC) samples were reviewed to develop this hypothesis.

Results: It is postulated that two inhalation products providing the same drug concentrations in airway lining fluid (ALF) could be considered bioequivalent. Read More

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http://dx.doi.org/10.1007/s40199-019-00250-xDOI Listing
March 2019
2 Reads
1.111 Impact Factor

Pharmacometabolomics applied to zonisamide pharmacokinetic parameter prediction.

Metabolomics 2018 May 9;14(5):70. Epub 2018 May 9.

Clinical Pharmacology Department, La Paz University Hospital, School of Medicine, IdiPAZ, Autonomous University of Madrid, Madrid, Spain.

Introduction: Zonisamide is a new-generation anticonvulsant antiepileptic drug metabolized primarily in the liver, with subsequent elimination via the renal route.

Objectives: Our objective was to evaluate the utility of pharmacometabolomics in the detection of zonisamide metabolites that could be related to its disposition and therefore, to its efficacy and toxicity.

Methods: This study was nested to a bioequivalence clinical trial with 28 healthy volunteers. Read More

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http://dx.doi.org/10.1007/s11306-018-1365-5DOI Listing
May 2018
4 Reads

Bioequivalence of 2 Naproxen Sodium Tablet Formulations in Healthy Male and Female Volunteers.

Curr Ther Res Clin Exp 2019 18;90:33-38. Epub 2019 Jan 18.

Simbec Research Ltd, Merthyr Tydfil, United Kingdom.

Background: Naproxen is an established, effective treatment for pain management in acute musculoskeletal disorders and traumatic sports injuries. Reckitt Benckiser Health Limited have developed a naproxen sodium tablet with the same pharmacokinetic and pharmacodynamic properties as existing marketed naproxen products with the intention of increasing the number of naproxen products available for prescribers and pharmacies.

Objective: This study aimed to assess comparative bioavailability between a test medicinal product developed by Reckitt Benckiser Health Limited (RB, 103-105 Bath Rd, Slough, SL1 3UH, United Kingdom; RB naproxen sodium 220 mg tablets), and a reference medicinal product, Aleve naproxen sodium 220 mg (Bayer B. Read More

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http://dx.doi.org/10.1016/j.curtheres.2019.01.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6383175PMC
January 2019
1 Read

Integrating chemical similarity and bioequivalence: A pilot study on quality consistency evaluation of dispensing granule and traditional decoction of Scutellariae Radix by a totality-of-the-evidence approach.

J Pharm Biomed Anal 2019 May 19;169:1-10. Epub 2019 Feb 19.

State Key Laboratory of Natural Medicines, China Pharmaceutical University, No. 24 Tongjia Lane, Nanjing, 210009, China. Electronic address:

There is an increasing focus on the quality consistency evaluation of dispensing granule in traditional Chinese medicines (TCMs). According to the guideline from Chinese Pharmacopoeia Commission, the substantial equivalence of dispensing granule and traditional decoction should be determined, and the chromatographic fingerprint has been recommended as a comprehensive qualitative approach to assess the quality consistency between dispensing granule and traditional decoction. However, a high-degree chemical similarity does not equal a bioequivalence. Read More

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http://dx.doi.org/10.1016/j.jpba.2019.02.030DOI Listing
May 2019
1 Read

Study on Drug-Drug Interactions Between Chiglitazar, a Novel PPAR Pan-Agonist, and Metformin Hydrochloride in Healthy Subjects.

Clin Pharmacol Drug Dev 2019 Feb 27. Epub 2019 Feb 27.

Drug Clinical Trials Institution, The First Affiliated Hospital of Soochow University, Suzhou City, Jiangsu Province, P.R.China.

Chiglitazar (CHI) is a potent and selective peroxisome proliferator-activated receptor potentially for the treatment of patients with type 2 diabetes mellitus (T2DM). An open-label, randomized, 3-period crossover and self-controlled study was conducted to investigate drug-drug interaction potential between CHI and metformin hydrochloride (MET). Eligible subjects received a single oral dose of CHI (48 mg), MET (1000 mg), or a combination in each period, followed by serial blood sampling collected for up to 48 hours postdose, and safety was assessed throughout the trial. Read More

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http://dx.doi.org/10.1002/cpdd.668DOI Listing
February 2019

Simultaneous Determination and Quantitation of Diosmetin and Hesperetin in Human Plasma by Liquid Chromatographic Mass Spectrometry With an Application to Pharmacokinetic Studies.

J Chromatogr Sci 2019 Feb 27. Epub 2019 Feb 27.

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

Among the secondary metabolites which are widely distributed in plants and foods in plant origin flavonoids is important one. Flavonoids have antioxidant activities as free radical scavenging action. They also have anti-inflammatory, antiulcer and anti-carcinogenic activities. Read More

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http://dx.doi.org/10.1093/chromsci/bmz015DOI Listing
February 2019
6 Reads

Heparins Sourced From Bovine and Porcine Mucosa Gain Exclusive Monographs in the Brazilian Pharmacopeia.

Front Med (Lausanne) 2019 5;6:16. Epub 2019 Feb 5.

Laboratório de Tecido Conjuntivo, Hospital Universitário Clementino Fraga Filho and Instituto de Bioquímica Médica Leopoldo de Meis, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.

Most of the unfractionated heparin (UFH) consumed worldwide is manufactured using porcine mucosa as raw material (HPI); however, some countries also employ products sourced from bovine mucosa (HBI) as interchangeable versions of the gold standard HPI. Although accounted as a single UFH, HBI, and HPI have differing anticoagulant activities (~100 and 200 IU mg, respectively) because of their compositional dissimilarities. The concomitant use of HBI and HPI in Brazil had already provoked serious bleeding incidents, which led to the withdrawal of HBI products in 2009. Read More

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http://dx.doi.org/10.3389/fmed.2019.00016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6371698PMC
February 2019
1 Read

Pharmacokinetics and bioequivalence of two fenofibrate choline formulations in healthy subjects under fed and fasted condition
.

Int J Clin Pharmacol Ther 2019 Apr;57(4):217-228

Objective: The objective of this study was to evaluate the pharmacokinetics and bioequivalence of two formulations (the original capsule ("reference") and the new tablet ("test") formulations) of 135-mg choline fenofibrate under fed and fasted conditions.

Materials And Methods: This was an open-label, randomized, single-dose, crossover bioequivalence study in healthy Korean males. A total of 40 individuals were separately enrolled in the high-fat fed and the fasting study, respectively, and were randomized in a 1:1 ratio into two sequences. Read More

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http://dx.doi.org/10.5414/CP203353DOI Listing
April 2019
17 Reads

Bioequivalence for highly variable drugs: regulatory agreements, disagreements, and harmonization.

J Pharmacokinet Pharmacodyn 2019 Feb 23. Epub 2019 Feb 23.

Semmelweis University, Budapest, Hungary.

Regulatory authorities introduced procedures in the last decade for evaluating the bioequivalence (BE) for highly variable drugs. These approaches are similar in principle but differ in details. For example, the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) recommend differing regulatory constants. Read More

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http://dx.doi.org/10.1007/s10928-019-09623-wDOI Listing
February 2019
3 Reads

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 03 18;38(3):511-523. 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
March 2019
6 Reads

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

Br J Clin Pharmacol 2019 May 21;85(5):1003-1014. Epub 2019 Mar 21.

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 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://doi.wiley.com/10.1111/bcp.13902
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http://dx.doi.org/10.1111/bcp.13902DOI Listing
May 2019
2 Reads

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
2 Reads

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;14(1):67-74

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
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6407750PMC
February 2019
4 Reads

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 Mar 8;23(1):2-13. 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
March 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
4 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 using 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
1 Read

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

Eur J Pharm Sci 2019 Apr 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
April 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
5 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 Apr;57(4):331-338

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
April 2019
4 Reads

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

J Child Adolesc Psychopharmacol 2019 Apr 4;29(3):220-234. 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
April 2019
3 Reads
2.933 Impact Factor