Highly Variable Drugs: Observations from Bioequivalence Data Submitted to the FDA for New Generic Drug Applications

Barbara M. Davit, Dale P. Conner, Beth Fabian-Fritsch, +7

The AAPS Journal

BioequivalencePharmacologyBioequivalence Data SubmittedHighly Variable DrugsMedicine +4

Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance

Brian Booth, Mark E. Arnold, Binodh DeSilva, +14

The AAPS Journal

Fda GuidancePreclinical Drug EvaluationMedicineBioanalysisPharmacology +6

2012 White Paper on Recent Issues in Bioanalysis And Alignment of Multiple Guidelines

Binodh DeSilva, Fabio Garofolo, Mario L. Rocci, +36

Bioanalysis

EngineeringWhite PaperMultiple Regulatory AgenciesBiologic AgentBiochemical Taxonomy +24

Evaluation of a Scaling Approach for the Bioequivalence of Highly Variable Drugs

Sam Haidar, Fairouz Makhlouf, Donald J. Schuirmann, +4

The AAPS Journal

Pharmacokinetic ModelingBioequivalenceMedicineBioanalysisScaling Approach +7

Pharmacokinetics, Absolute Bioavailability, and Absorption Characteristics of Lamivudine

Geoffrey J. Yuen, David M. Morris, Patricia K. Mydlow, +3

The Journal of Clinical Pharmacology

2013 White Paper on Recent Issues in Bioanalysis: ‘ <i>Hybrid</i> ’ – The Best of LBA and LCMS

Lauren Stevenson, Fabio Garofolo, Binodh DeSilva, +57

Bioanalysis

White PaperChemical BiologyBioanalysisAnalytical ChemistryClinical Chemistry +17

2015 White Paper on Recent Issues in Bioanalysis: Focus on New Technologies and Biomarkers (Part 3 – Lba, Biomarkers and Immunogenicity)

Lakshmi Amaravadi, An Song, Heather Myler, +46

Bioanalysis

2017 White Paper on Recent Issues in Bioanalysis: A Global Perspective on Immunogenicity Guidelines &amp; Biomarker Assay Performance (Part 3 – Lba: Immunogenicity, Biomarkers and PK Assays)

Shalini Gupta, Susan Richards, Lakshmi Amaravadi, +64

Bioanalysis

ImmunohematologyPk AssaysWhite PaperImmunologyBiological Mass Spectrometry +25

Effect of Common Excipients on the Oral Drug Absorption of Biopharmaceutics Classification System Class 3 Drugs Cimetidine and Acyclovir

Soundarya Vaithianathan, Sam Haidar, Xinyuan Zhang, +9

Journal of Pharmaceutical Sciences

Pharmaceutical ScienceDrugs CimetidinePharmacological StudyExcipientsPharmacology +6

2016 White Paper on Recent Issues in Bioanalysis: Focus on Biomarker Assay Validation (BAV): (Part 3 – Lba, Biomarkers and Immunogenicity)

Susan Richards, Lakshmi Amaravadi, Renuka Pillutla, +50

Bioanalysis

EngineeringWhite PaperImmunologyBiological Mass SpectrometryPathology +31