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ICH M10 Guidance: Harmonization and Modification to Bioanalytical Method Variation

Internal Standard (IS) Variation Case Studies: Emerging From Three Common IS Challenges

Metabolite Identification (MetID): A Critical Step in Drug Discovery and Development

Bridging Preclinical and Clinical Assays for Biologics Development –Challenges and Considerations for Phase I Trials

The 2019 FDA Guidance’s Implications for Immunogenicity Assessment

Comparison Between Magnetic Bead and Membrane Immunoaffinity Purification Methods for the Measurement of Monoclonal Antibody in Rat Serum

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Drug Metabolism and Pharmacokinetics


Hot Topics and Challenges in Drug Development

Expediting Biologics Drug Development: Strategies to Accelerate Preclinical Development Timelines

DMPK Strategies for Successful Clinical Translation

DMPK Addressing Safety Testing of Drug Metabolites (MIST) in Drug Development

AAPS – The Unique Bioanalytical Needs of New Modalities