Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies

Vinod P. Shah, Kamal K. Midha, Shrikant V. Dighe, +43

International Journal of Pharmaceutics

Analytical Methods ValidationMedicineBioanalysisPharmacologyPharmacokinetics

2010 White Paper on Recent Issues in Regulated Bioanalysis & Global Harmonization of Bioanalytical Guidance

Natasha Savoie, Fabio Garofolo, Peter van Amsterdam, +19

Bioanalysis

EngineeringWhite PaperValidation Group WorkshopBioanalysisAnalytical Chemistry +19

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

The 2nd Calibration and Validation Group Workshop on Recent Issues in Good Laboratory Practice Bioanalysis

Natasha Savoie, Brian Booth, T Hyman Bradley, +12

Bioanalysis

EngineeringMeasurementBioanalytical DataValidation Group WorkshopAnalytical Instrumentation +24

2011 White Paper on Recent Issues in Bioanalysis and Regulatory Findings from Audits and Inspections

Fabio Garofolo, Mario L. Rocci, Isabelle Dumont, +28

Bioanalysis

Continuous AuditingWhite PaperAuditingInvestigative StudyBioanalysis +22

Short-term pathological and proliferative effects of butylated hydroxyanisole and other phenolic anti-oxidants in the forestomach of Fischer 344 rats

E.A. Nera, E. Lok, F. Iverson, +3

Toxicology

Butylated HydroxyanisoleMedicineLipid PeroxidationPhytochemistryOther Phenolic Anti-oxidants +7

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

Evidence that amikacin ototoxicity is related to total perilymph area under the concentration-time curve regardless of concentration

A R Beaubien, Eric Ormsby, Aaron Bayne, +5

Antimicrobial Agents and Chemotherapy

Amikacin OtotoxicityPharmacotherapyTotal Perilymph AreaDrug ResistancePharmacological Study +14

Logarithmic Transformation in Bioequivalence: Application with Two Formulations of Perphenazine

K.K. Midha, Eric Ormsby, John W. Hubbard, +4

Journal of Pharmaceutical Sciences

Pharmaceutical ScienceLogarithmic TransformationChemical TransformationBiochemistryBioequivalence +5

Incidence of amikacin ototoxicity: A sigmoid function of total drug exposure independent of plasma levels

A R Beaubien, Suzanne Desjardins, Eric Ormsby, +7

American Journal of Otolaryngology

AllergyAmikacin OtotoxicityPlasma LevelsMedicineToxicology +8