Published 2023
Table of Contents:
“...Absolute bioavailability (ABA) -- Novel study design: duo-tracer for ABA and mass balance in a single-period study -- Conclusions -- References -- 11 -- Conquering low oral bioavailability issues in drug discovery and development -- Introduction -- Characterization of bioavailability -- In vivo approaches -- In vitro approaches -- Solubility and permeability -- First pass metabolism -- Design of molecules for optimizing bioavailability -- Rule-based approaches to design --
Computational modeling -- Formulation strategies to optimize bioavailability -- Conclusion -- References -- 12 -- Case study of OATP1B DDI assessment and challenges in drug discovery and development-real-life examples -- Background -- BMS-919373 -- Estimation of drug interaction potential for BMS-919373 using in vitro data -- Pharmacokinetcs of rosuvastatin and BMS-919373 in cynomolgus monkeys -- (A) BMS-919373 20mg/kg -- (B) BMS-919373 1mg/kg -- Pharmacokinetics of statins and BMS-919373 in human subjects -- Safety -- Discussion -- Conclusion -- References -- 13 -- Investigating the link between drug metabolism and toxicity -- Introduction -- Utility of metabolite-mediated toxicity information in discovery and development -- Discovery studies -- Development studies -- Metabolites in safety
testing considerations -- Species specific metabolism-related toxicology -- Metabolism-related toxicology during clinical development -- Methods to investigate metabolite-mediated toxicology -- Exposure at site of action -- In vitro methods -- In vivo methods -- Examples of metabolite-mediated toxicity -- General -- Amgen PI3K inhibitor
program -- Bristol-Myers Squibb MET kinase inhibitor -- Saxagliptin -- Empagliflozin -- SGX523 -- Conclusions -- Abbreviations -- References -- 14 -- Overcoming nephrotoxicity in rats: the successful development and registration of the HIV-AIDS drug efavirenz....
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