Identification and Quantification of Drugs, Metabolites, Drug Metabolizing Enzymes, and Transporters

Part I: Techniques for Identifying and Quantifying Drugs and Metabolites1. Bioanalysis of Small and Large Molecule Drugs, Metabolites, and Biomarkers by LC-MS2. Recent advances in mass spectrometric and other analytical techniques for the identification of drug metabolites 3. High-resolution mass spectrometry-based data acquisition and data mining technologies for detecting and characterizing drug metabolites and herbal medicine components4. Metabolite Generation and Metabolite Characterization by NMR5. Application of SFC for bioanalysis6. AMS in drug development: Exploring the current utility of AMS and future opportunities for Absolute Bioavailability and ADME investigations Part II: Drug Metabolism Enzymes, Transporters and Drug-Drug Interaction7. Using in vitro methods to determine P450s responsible for metabolism and discrimination from other oxidative pathways8. Evaluation of the clearance mechanism of non-CYP enzymes mediated drug metabolism and DDI as a victim drug 9. In vitro Characterization and In Vitro to In Vivo Predictions of Drug-Drug Interactions10. Role of Transporters in drug disposition and Drug-drug Interactions11. Mechanisms and Clinical Relevance of Pharmacokinetic-based Clinical Drug-drug Interactions for Drugs Recently Approved by the U.S. Food and Drug Administration 12. Quantifying drug metabolism enzymes and transporters by LC-MS/MS proteomics 13. Protein Drug-Drug Interactions for Disease Modifying Modalities Part III: Strategy Related to Drug Metabolism and Safety14. Metabolites in safety testing (MIST)15. The Use of Stable Isotopes in Drug Metabolism Studies 16. Assessment of Stereoselectivity in Pharmacology, Toxicology and Drug Metabolism 17. Progress of De-Risking Strategies for Drug-Induced Liver Injury (DILI) In the Last Two Decades18. Predictive and Translational Models for Renal Drug Safety Evaluation19. Immunogenicity: An Introduction to Its Role in the Safety and Efficacy of Biotherapeutics Part IV: Translational Sciences20. Application of Genetically-Modified Rodent Models in Drug Discovery and Development for Translation of Clinical ADME Properties21. Advances in CRISPR Technologies Enable Novel in vitro Tools for ADME Studies22. In vitro-In vivo Extrapolation of Human Hepatic and Renal Clearance23 The Role of Mathematical Modeling in Translational Science 24. PK/PD Driven Starting and Effective Human Dose Determination for Immuno-Oncology Drugs