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    Evolution of fit-for-purpose biomarker validations: an LBA perspective.
    Bioanalysis 2018 Jun 20. Epub 2018 Jun 20.
    Senior Research Investigator, Bioanalytical Sciences-Biomarkers, Bristol-Myers Squibb, Route 206 & Province Line Road, Princeton, NJ 08543-4000, USA.
    Biomarker ligand-binding assays need to be validated for use on clinical studies in the drug development process. There is not one single guidance to cover all types of biomarker assays and their intended uses. Therefore, it is up to the scientist to piece together a validation strategy based on published papers and other sources. Read More

    Clinical biomarker validation.
    Bioanalysis 2018 Jun 20. Epub 2018 Jun 20.
    Biomarker Specialist and Consultant, Flatfield Lodge, Hull Road, Howden, DN14 7LP, East Riding of Yorkshire, UK.
    Biomarker assays have brought significant challenges to bioanalytical laboratories that historically have provided pharmacokinetic analytical services to the drug development industry. This has largely been due to two reasons: the lack of regulatory guidance in how to validate biomarker assays and the lack of scientists in bioanalytical laboratories with experience in this clinical arena. Since biomarkers have been measured for many decades in clinical laboratories globally, this article reviews the different types of analytical laboratories and their practices and case studies will demonstrate the potential outcomes of using biomarker assays in drug development when they are not validated correctly. Read More

    Biomarkers in early-phase trials: fundamental issues.
    Bioanalysis 2018 Jun 20. Epub 2018 Jun 20.
    Division of Cancer Treatment & Diagnosis, National Cancer Institute, National Institutes of Health, Rockville, MD, 20850, USA.
    Biomarkers are frequently being included in early phase clinical trials. This article is meant to introduce clinical investigators to the fundamentals of choosing a biomarker test for use in an early phase trial. Steps to consider are briefly outlined including defining the role of the biomarker in the early phase trial; selecting a fit-for-purpose biomarker test and laboratory; describing the test procedures; carrying out analytical validation testing appropriate for the research objectives and the risk involved in the trial; implementing the test in the trial; and planning for the future. Read More

    Concerted application of LC-MS and ligand binding assays to better understand exposure of a large molecule drug.
    Bioanalysis 2018 Jun 20. Epub 2018 Jun 20.
    Bioanalytical Sciences, Translational Sciences, Bristol-Myers Squibb, Princeton, NJ 08543, USA.
    Aim: A ligand-binding assay (LBA) was used to measure exposure of PRM-151, the recombinant form of human pentraxin-2 (PTX-2), a complex pentamer with multiple binding partners. However, the assay showed a lack of dose-dependent exposure in select preclinical species and it could not differentiate the infused PRM-151 from the endogenous PTX-2 in nonhuman primates.

    Materials & Methods: Instead of assessing interference from its multiple binding partners, which could be time consuming and laborious, a LC-MS assay avoid of these interference was implemented to measure 'total' drug without the use of immunoaffinity capture reagents. Read More

    A novel LC-MS/MS assay to quantify dermatan sulfate in cerebrospinal fluid as a biomarker for mucopolysaccharidosis II.
    Bioanalysis 2018 Jun 4;10(11):825-838. Epub 2018 Jun 4.
    Shire, 300 Shire Way, Lexington, MA 02421, USA.
    Aim: The study aimed to develop an LC-MS/MS assay to measure dermatan sulfate (DS) in human cerebrospinal fluid (CSF).

    Methods & Results: DS was quantified by ion pairing LC-MS/MS analysis of the major disaccharides derived from chondroitinase B digestion. Artificial CSF was utilized as a surrogate for calibration curve preparation. Read More

    Novel and rapid LC-MS/MS method for quantitative analysis of methylphenidate in dried blood spots.
    Bioanalysis 2018 Jun 4;10(11):839-850. Epub 2018 Jun 4.
    Office of Clinical Pharmacology, Center for Drugs Evaluation & Research, US Food & Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
    Aim: Development and validation of a novel, sensitive, specific and rapid dried blood spots (DBS)-LC-MS/MS method for methylphenidate (MPH), an attention-deficit hyperactivity disorder drug. Methodology & results: Protein precipitation with acetonitrile was used to extract MPH from the DBS cards. Chromatographic separation was achieved on a Zorbax C18 column using an isocratic mobile phase composed of acetonitrile and 5 mM ammonium formate buffer (20:80, v/v) at a flow rate of 0. Read More

    Determination of a PDE4 inhibitor Hemay005 in human plasma and urine by UPLC-MS/MS and its application to a PK study.
    Bioanalysis 2018 Jun 4;10(11):863-875. Epub 2018 Jun 4.
    Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100730, PR China.
    Aim: Hemay005 is a novel small-molecule inhibitor of phosphodiesterase-4 developed for the treatment of psoriasis. Measurement of Hemay005 in biological samples is critical for evaluation of its pharmacokinetics in clinical studies. Methodology & results: Plasma and urine samples were extracted and then chromatographed on an Acquity UPLC HSS T3 column with a gradient elution. Read More

    LC-HRMS quantitation of intact antibody drug conjugate trastuzumab emtansine from rat plasma.
    Bioanalysis 2018 Jun 4;10(11):851-862. Epub 2018 Jun 4.
    SCIEX, 71 Four Valley Drive, Concord, Ontario, L4K 4V8, Canada.
    Aim: Compared with small molecules, LC-MS quantitation of larger biotherapeutic proteins such as antibodies and antibody-drug conjugates at the intact level presents many challenges in both LC and MS due to their higher molecular weight, bigger size, structural complexity and heterogeneity.

    Results & Conclusion: In this study, quantitation of an intact lysine-linked antibody-drug conjugate, trastuzumab emtansine is presented. Trastuzumab emtansine was extracted from rat plasma using bead-based immunoaffinity capture; after elution from the beads, it was directly analyzed on a LC-HRMS system. Read More

    Simple and robust LC-MS/MS analysis method for therapeutic drug monitoring of micafungin.
    Bioanalysis 2018 Jun 4;10(11):877-886. Epub 2018 Jun 4.
    Universityof Groningen, University Medical Center Groningen, Department of ClinicalPharmacy and Pharmacology, Groningen, The Netherlands.
    Aim: To develop a simple and robust LC-MS/MS method to quantify concentrations of micafungin in human plasma for pharmacokinetic studies and therapeutic drug monitoring.

    Methods: Sample preparation involved protein precipitation with acetonitrile:methanol (83:17% v/v) and [C]-micafungin as internal standard. A rapid and selective method for micafungin was validated across a range of 0. Read More

    LC-MS/MS method for simultaneous determination of famitinib and its major metabolites in human plasma.
    Bioanalysis 2018 Jun 4;10(11):791-801. Epub 2018 Jun 4.
    Department of Pharmacy, Changzheng Hospital, Second Military Medical University, Shanghai, 200003, PR China.
    Aim: To establish and validate an ultra-high-performance liquid chromatography-tandem mass spectrometry method for the rapid and simultaneous determination of famitinib and its metabolites in human plasma.

    Results: All analytes demonstrated good correlation coefficients (R > 0.99), and the LLOQ was 0. Read More

    Capillary blood microsampling to determine serum biopharmaceutical concentration: Mitra microsampler vs dried blood spot.
    Bioanalysis 2018 Jun 4;10(11):815-823. Epub 2018 Jun 4.
    Department of Immunopathology, Sanquin Research & Landsteiner Laboratory Academic Medical Centre, 1006 CX Amsterdam, The Netherlands.
    Aim: For assessment of concentrations of biopharmaceuticals, for example, therapeutic drug monitoring, dried blood sampling of capillary blood is a convenient alternative to traditional venepuncture sampling. We investigated an alternative to dried blood spot collection on filter paper: sampling capillary blood using the Mitra microsampler.

    Materials And Methods:  Therapeutic monoclonal antibodies were spiked in whole blood, sampled using filter paper and Mitra microsampler and concentrations measured using specific ELISAs. Read More

    Development of a rapid UPLC-MS/MS determination of urine sulfocysteine for diagnosis of sulfocysteinuria and molybdenum co-factor deficiencies.
    Bioanalysis 2018 May 18;10(10):747-756. Epub 2018 May 18.
    Division of Biochemical Genetics, Baylor Genetics, Houston, TX 77021, USA.
    Aim: Molybdenum co-factor deficiencies and isolated sulfite oxidase deficiency are rare autosomal recessively inherited diseases characterized by severe psychomotor impairment, intractable seizures, dislocated lens and dysmorphic facial features. The biochemical diagnosis of these diseases requires the determination of urine sulfocysteine.

    Materials & Methods: Urine sulfocysteine was quantified by an ultra-high performance liquid chromatography-MS/MS assay. Read More

    What sample preparation should be chosen for targeted MS monoclonal antibody quantification in human serum?
    Bioanalysis 2018 May 17;10(10):723-735. Epub 2018 May 17.
    University of Montpellier, LBPC- IRMB, CHU Montpellier, 80 rue Augustin Fliche, Montpellier, France.
    Aim: Monoclonal antibody-based treatment of cancer has been established as one of the most successful therapeutic strategies.

    Materials & Methods: In this work, we developed a workflow based on an automated protein-A capture and LC-MS/MS analysis to quantify bevacizumab on patient serum during treatment. This analytical approach was fully validated and compared with a commercially available Monoclonal antibody-based treatment preparation (nanosurface and molecular-orientation limited kit). Read More

    Design of experiment in assessing robustness and for qualification of a cell-based potency assay.
    Bioanalysis 2018 May 17;10(10):737-746. Epub 2018 May 17.
    Piramal Pharma Solutions, Analytical Development, Earls Road, Grangemouth, Stirlingshire FK3 8XG, United Kingdom.
    Aim: This paper describes the salient points in establishing robustness of the cell-based potency assay, with reference to phase-specific qualification.

    Materials & Methods: The methodology was qualified in a thaw for use format utilizing standard parameters. At a later stage, the assay was further developed, and concomitant with requalification the robustness was assessed by fractional factorial design of experiment, the center point data being used for qualification. Read More

    Electromembrane extraction of substances with weakly basic properties: a fundamental study with benzodiazepines.
    Bioanalysis 2018 May 17;10(10):769-781. Epub 2018 May 17.
    Department of Pharmaceutical Chemistry, School of Pharmacy, University of Oslo, P.O. Box 1068, Blindern, 0316 Oslo, Norway.
    Aim: Electromembrane extraction (EME) of weakly basic benzodiazepines was investigated (-1.47 < pKa < 5.01). Read More

    Comparative diagnostics of allergy using quantitative immuno-PCR and ELISA.
    Bioanalysis 2018 May 17;10(10):757-767. Epub 2018 May 17.
    Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry of the Russian Academy of Sciences, 16/10, Miklukho-Maklaya St., 117997, Moscow, Russian Federation.
    Aim: Estimation of specific IgE is essential for the prevention of allergy progression. Quantitative immuno-PCR (qiPCR) can increase the sensitivity of IgE detection. We aimed to develop qiPCR and compare it to the conventional ELISA in identification of IgE to Alt a 1 and Fel d 1 allergens. Read More

    UHPLC-MS/MS bioanalysis of human plasma coproporphyrins as potential biomarkers for organic anion-transporting polypeptide-mediated drug interactions.
    Bioanalysis 2018 May 11;10(9):633-644. Epub 2018 May 11.
    Analytical & Bioanalytical Operations, Bristol-Myers Squibb Company, Princeton, NJ 08543, USA.
    Aim: Coproporphyrins (CP-I and CP-III) have been identified as possible biomarkers to predict human hepatic organic anion-transporting polypeptides-mediated-drug-interactions for a new drug entering clinical development.

    Results: The method is applicable to quantify plasma CP-I and CP-III within 0.078-15. Read More

    LC-MS/MS assay for N-methylnicotinamide in humans, an endogenous probe for renal transporters.
    Bioanalysis 2018 May 11;10(9):673-689. Epub 2018 May 11.
    Department of Pharmacokinetics, Dynamics & Metabolism, Research & Development, Pfizer, Inc., 445 Eastern Point Road, Groton, CT 06340, USA.
    Background: N-methylnicotinamide (1-NMN) has been proposed as a potential clinical biomarker to assess drug-drug interactions involving organic cation transporters (OCT2) and multidrug and toxin extrusion protein transporters.

    Results: A hydrophilic interaction liquid chromatography-MS/MS assay, to quantify 1-NMN, in human plasma and urine is reported.

    Materials & Methods: A hydrophilic interaction chromatography (HILIC)-tandem mass spectrometry (MS/MS) assay to quantify 1-NMN in human plasma and urine is reported. Read More

    A multiplex HRMS assay for quantifying selected human plasma bile acids as candidate OATP biomarkers.
    Bioanalysis 2018 May 11;10(9):645-657. Epub 2018 May 11.
    Pfizer Global Research & Development, Medicinal Sciences, Groton, CT, 06340, USA.
    Aim: Selected bile acids (BAs) in plasma have been proposed as endogenous probes for assessing drug-drug interactions involving hepatic drug transporters such as the organic anion-transporting polypeptides (OATP1B1 and OATP1B3).

    Materials & Methods: Plasma extracts were analyzed for selected BAs using a triple TOF API6600 high-resolution mass spectrometer.

    Results: Glycodeoxycholic acid 3-sulfate, glycochenodeoxycholic acid 3-sulfate, glycodeoxycholic acid 3-O-β-glucuronide and glycochenodeoxycholic acid 3-O-β-glucuronide are presented as potential OATP1B1/3 biomarkers. Read More

    HPLC-high-resolution mass spectrometry with polarity switching for increasing throughput of human in vitro cocktail drug-drug interaction assay.
    Bioanalysis 2018 May 11;10(9):659-671. Epub 2018 May 11.
    STEM Department, Kean University, 1000 Morris Avenue, Union, NJ 07083, USA.
    Aim: Evaluation of HPLC-high-resolution mass spectrometry (HPLC-HRMS) full scan with polarity switching for increasing throughput of human in vitro cocktail drug-drug interaction assay.

    Materials & Methods: Microsomal incubates were analyzed using a high resolution and high mass accuracy Q-Exactive mass spectrometer to collect integrated qualitative and quantitative (qual/quant) data.

    Results: Within assay, positive-to-negative polarity switching HPLC-HRMS method allowed quantification of eight and two probe compounds in the positive and negative ionization modes, respectively, while monitoring for LOR and its metabolites. Read More

    A fully automated and validated human plasma LC-MS/MS assay for endogenous OATP biomarkers coproporphyrin-I and coproporphyrin-III.
    Bioanalysis 2018 May 11;10(9):691-701. Epub 2018 May 11.
    PPD, Bioanalysis, Middleton, WI, USA, 53562.
    Aim: A validated LC-MS/MS assay for the quantitation of coproporphyrin-I and -III (CP-I, CP-III) in human plasma has been developed to understand the utility of both as possible endogenous biomarkers for organic anion-transporting polypeptides (OATP)-mediated drug-drug interactions (DDIs).

    Materials And Methods:  Human plasma extracts were analyzed for CP-I and CP-III using a Sciex API 6500+ mass spectrometer. Results: The assay was utilized for plasma samples from a clinical DDI study involving a new chemical entity that presented as an OATP inhibitor in vitro. Read More

    UPLC/MS-MS assay development for estimation of mozavaptan in plasma and its pharmacokinetic study in rats.
    Bioanalysis 2018 May 10. Epub 2018 May 10.
    Department of Pharmacology & Toxicology, Faculty of Pharmacy (Girls), Al-Azhar University, Cairo, Egypt.
    Aim: Mozavaptan is a nonpeptide vasopressin receptor antagonist approved for the treatment of ectopic antidiuretic hormone secretion syndrome.

    Methods & Results: A simple, rapid and fully validated UPLC/MS-MS method was developed for the quantitation of mozavaptan in rat plasma. The chromatographic separation was conducted on an Acquity UPLC BEH™ C column with an optimum mobile phase of 10 mM ammonium acetate buffer and 0. Read More

    Report on the 18th Annual Land O'Lakes Bioanalytical Conference.
    Bioanalysis 2018 Apr 10;10(7):445-449. Epub 2018 Apr 10.
    Bristol-Myers Squibb, Princeton, NJ 08540, USA.
    The 18th Annual Land O'Lakes Bioanalytical Conference, titled 'Cutting-Edge Bioanalytical Technologies and Concepts - Issues, Solutions and Practical Considerations for Applications in Novel and Emerging Modalities', was held 10-13 July 2017 in Madison, WI, USA. This Land O'Lakes Conference is presented each year by the Division of Pharmacy Professional Development within the School of Pharmacy at the University of Wisconsin-Madison (USA). The purpose of this conference is to provide an educational forum to discuss issues and applications associated with the analysis of xenobiotics, metabolites, biologics and biomarkers in biological matrices. Read More

    Surface plasmon resonance as a tool for ligand-binding assay reagent characterization in bioanalysis of biotherapeutics.
    Bioanalysis 2018 Apr 27;10(8):559-576. Epub 2018 Apr 27.
    Bioanalytical Sciences, Analytical & Bioanalytical Operations, Bristol-Myers Squibb, Princeton, NJ 08543, USA.
    Ligand-binding assay (LBA) performance depends on quality reagents. Strategic reagent screening and characterization is critical to LBA development, optimization and validation. Application of advanced technologies expedites the reagent screening and assay development process. Read More

    11th GCC Closed Forum: cumulative stability; matrix stability; immunogenicity assays; laboratory manuals; biosimilars; chiral methods; hybrid LBA/LCMS assays; fit-for-purpose validation; China Food and Drug Administration bioanalytical method validation.
    Bioanalysis 2018 Apr 27;10(7):433-444. Epub 2018 Apr 27.
    Worldwide Clinical Trials, Austin, TX, USA.
    The 11th Global CRO Council Closed Forum was held in Universal City, CA, USA on 3 April 2017. Representatives from international CRO members offering bioanalytical services were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The second CRO-Pharma Scientific Interchange Meeting was held on 7 April 2017, which included Pharma representatives' sharing perspectives on the topics discussed earlier in the week with the CRO members. Read More

    A validated UPLC-MS/MS method for flibanserin in plasma and its pharmacokinetic interaction with bosentan in rats.
    Bioanalysis 2018 Apr 25. Epub 2018 Apr 25.
    Department of Pharmaceutical Chemistry, College of Pharmacy, King Saud University, PO Box No 2457 Riyadh, Saudi Arabia.
    Aim: The purpose of this study was development, validation and application of ultra-performance liquid chromatography (UPLC)-ESI-MS/MS method for quantitation of flibanserin in plasma samples.

    Method & Results: After extraction of analyte from plasma by diethyl ether, separation was performed on UPLC C column using mobile phase composition of 10 mM ammonium formate-acetonitrile (30:70, v/v) by isocratic elution of 0.3 ml/min. Read More

    Immunogenicity testing of therapeutic antibodies in ocular fluids after intravitreal injection.
    Bioanalysis 2018 Jun 11;10(11):803-814. Epub 2018 Apr 11.
    Pharmaceutical Sciences, Pharma Research & Early Development, Roche Innovation Center Munich, Nonnenwald 2, 82377 Penzberg, Germany.
    Aim: High drug concentrations in ocular fluids after intravitreal administration preclude the use of drug-sensitive immunoassays. A drug-tolerant immunoassay is therefore desirable for immunogenicity testing in ophthalmology.

    Experimental: Immune complex (IC) antidrug antibody (ADA) assays were established for two species. Read More

    Developing novel methods for protein, peptide and metabolite analysis.
    Bioanalysis 2018 Apr 10;10(7):431-432. Epub 2018 Apr 10.
    Analytical Biochemistry, Department of Pharmacy, University of Groningen, Antonius Deusinglaan 1, 9713 AV Groningen, The Netherlands.
    Rainer Bischoff, Professor of Analytical Biochemistry at the University of Groningen (Groningen, The Netherlands), talks to Sankeetha Nadarajah, Managing Commissioning Editor (Bioanalysis), regarding the development of novel methods for protein, peptide and metabolite analysis. Read More

    Validated HPLC-UV detection method for the simultaneous determination of ceftolozane and tazobactam in human plasma.
    Bioanalysis 2018 Apr 10;10(7):461-473. Epub 2018 Apr 10.
    Institute for Health Research (INCLIVA), University Clinical Hospital of Valencia, Valencia, Spain.
    Aim: A simple, rapid, economical and sensitive HPLC-UV method was developed for the simultaneous quantification of ceftolozane and tazobactam in plasma samples.

    Methodology: After deproteinization followed by a liquid-liquid back-extraction, the compounds were separated on a C18 column (150 mm × 4.6 mm, 5 μm) with UV-visible detection at 220 nm. Read More

    Approaches to measure protein binding of enzymatically unstable compounds in plasma.
    Bioanalysis 2018 Apr 10;10(7):451-459. Epub 2018 Apr 10.
    Drug Metabolism & Pharmacokinetics, Vertex Pharmaceuticals, Inc. Boston, MA 02210, USA.
    Aim: To develop approaches to measure plasma protein binding (PPB) of enzymatically unstable compounds.

    Methodology: Bis-para-nitrophenyl phosphate (BNPP) was used to inhibit enzyme activity and stabilize two model compounds (diltiazem and oseltamivir) that are subject to enzyme-catalyzed hydrolysis in plasma. Protein binding of the compounds in BNPP-treated rat plasma was measured using equilibrium dialysis or ultrafiltration. Read More

    Proposal for risk-based scientific approach on full and partial validation for general changes in bioanalytical method.
    Bioanalysis 2018 Apr 10;10(8):577-586. Epub 2018 Apr 10.
    Research Division, Chugai Pharmaceutical Co., Ltd., 1-135 Komakado, Gotemba, Shizuoka 412-8513, Japan.
    The guidance and several guidelines on bioanalytical method validation, which were issued by the US FDA, EMA and Ministry of Health, Labour and Welfare, list the 'full' validation parameters; however, none of these provide any details for 'partial' validation. Japan Bioanalysis Forum approved a total of three annual discussion groups from 2012 to 2014. In the discussion groups, members from pharmaceutical companies and contract research organizations discussed the details of partial validation from a risk assessment viewpoint based on surveys focusing on bioanalysis of small molecules using LC-MS/MS in Japan. Read More

    Validated UHPLC-MS/MS method for quantification of doxycycline in abdominal aortic aneurysm patients.
    Bioanalysis 2018 Apr 10;10(8):527-539. Epub 2018 Apr 10.
    Pharmacokinetics & Biopharmaceutics Lab (PBL), Department of Pharmaceutical Science, School of Pharmacy, University of Maryland, Baltimore, MD 21201, USA.
    Aim: There is a strong evidence that doxycycline can benefit abdominal aortic aneurysms patients because of its ability to inhibit matrix metalloproteinase enzymes. There is a need for a specific quantification method for doxycycline in these patients. We report herein the development and validation of a selective, specific, simple and rapid UHPLC-MS/MS method for doxycycline. Read More

    Targeting human urinary metabolome by LC-MS/MS: a review.
    Bioanalysis 2018 Apr 21;10(7):489-516. Epub 2018 Mar 21.
    Department of Experimental & Health Sciences, Universitat Pompeu Fabra (CEXS-UPF), Doctor Aiguader 88, 08003, Barcelona, Spain.
    Urine is a biological matrix that contains hundreds of metabolic end products which constitute the urinary metabolome. The development and advances on LC-MS/MS have revolutionized the analytical study of biomolecules by enabling their accurate identification and quantification in an unprecedented manner. Nowadays, LC-MS/MS is helping to unveil the complexity of urine metabolome, and the results obtained have multiple biomedical applications. Read More

    Mechanistic study for the simultaneous determination of metformin and teneligliptin in human plasma using hydrophilic interaction liquid chromatography-MS/MS.
    Bioanalysis 2018 Apr 21;10(7):475-488. Epub 2018 Mar 21.
    Chemistry Department, St Xavier's College, Ahmedabad 380009, Gujarat, India.
    Aim: A simple, selective and sensitive hydrophilic interaction liquid chromatography-MS/MS method is developed for the simultaneous determination of metformin (MET) and teneligliptin (TEN) in human plasma using deuterated internal standards. The mechanism of retention of analytes was studied by varying the proportion of organic diluent, buffer strength, pH of the mobile phase and temperature.

    Results: The results showed a mixed-mode mechanism comprising of hydrophilic (partition) and electrostatic interaction (ion exchange) for MET and essentially hydrophilic for TEN. Read More

    Drug exposure during pregnancy: analytical methods and toxicological findings.
    Bioanalysis 2018 Apr 21;10(8):587-606. Epub 2018 Mar 21.
    Institute of Emerging Health Professions, Thomas Jefferson University, Philadelphia, PA 19107, USA.
    Drug use during pregnancy constitutes a major preventable worldwide public health issue. Birth defects, growth retardation and neurodevelopmental disorders are associated with tobacco, alcohol or drugs of abuse exposure during pregnancy. Besides these adverse health effects, drug use during pregnancy also raises legal and social concerns. Read More

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