Medicines that matter: Biohaven’s Nurtec™ drug development journey Case Study Medicines that matter: Biohaven’s Nurtec™ drug development journey In February 2020, Biohaven Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved…CertaraAugust 15, 2024
Comparative pharmacokinetics of a single oral dose of meloxicam in the California sea lion (Zalophus californianus) and Pacific harbor seal (Phoca vitulina richardii) Publication Comparative pharmacokinetics of a single oral dose of meloxicam in the California sea lion (Zalophus californianus) and Pacific harbor seal (Phoca vitulina richardii) Explore how both pinniped species show long meloxicam half‑lives, suggesting dosing interval reconsideration, modelled using…CertaraJuly 14, 2024
Effect of Nutrition on Drug-Induced Liver Injury: Insights from a High-Fat Diet Mouse Model Publication Effect of Nutrition on Drug-Induced Liver Injury: Insights from a High-Fat Diet Mouse Model Discover how high‑fat diet reduces acetaminophen liver injury and increases clearance in mice, analysed using…CertaraJuly 12, 2024
Comparative pharmacokinetics of phenylbutazone in healthy young-adult and geriatric horses Publication Comparative pharmacokinetics of phenylbutazone in healthy young-adult and geriatric horses See how young and geriatric horses show similar phenylbutazone PK profiles, indicating no dose adjustment…CertaraJune 28, 2024
Ziprasidone population pharmacokinetics and co‑medication effects in Chinese patients Publication Ziprasidone population pharmacokinetics and co‑medication effects in Chinese patients Learn how lorazepam and valproate significantly affect ziprasidone clearance; PopPK modelling supports personalized dosing using…CertaraJune 25, 2024
Population pharmacokinetics of fluconazole for prevention or treatment of invasive candidiasis in Chinese young infants. Publication Population pharmacokinetics of fluconazole for prevention or treatment of invasive candidiasis in Chinese young infants. Find out how gestational and postnatal age drive fluconazole PK variability; PopPK modelling supports tailored…CertaraJune 8, 2024
Clinical Pharmacology & Model-Informed Drug Development Insights for Targeted Radiation Therapies On-Demand Webinar Clinical Pharmacology & Model-Informed Drug Development Insights for Targeted Radiation Therapies Targeted radiation therapies (TRT) deliver cytotoxic radiation selectively to tumors. In recent years, oncology drug…CertaraMay 22, 2024
Reflections on the new FDA clinical pharmacology guidance for antibody-drug conjugates Blog Reflections on the new FDA clinical pharmacology guidance for antibody-drug conjugates In recent years, oncology drug developers have invested in antibody-drug conjugates (ADCs). These targeted therapies…CertaraMay 10, 2024
Comparative Bioequivalence and Food Effect of Two Formulations of 30-mg Nifedipine Controlled-Release Tablets in Healthy Chinese Adults Publication Comparative Bioequivalence and Food Effect of Two Formulations of 30-mg Nifedipine Controlled-Release Tablets in Healthy Chinese Adults Explore how nifedipine CR formulations are bioequivalent; food reduces exposure modestly, analysed using Phoenix WinNonlin.CertaraMarch 13, 2024