Physiologically- based pharmacokinetic modeling to support bioequivalence and approval of generic products: A case for diclofenac sodium topical gel, 1% Publication Physiologically- based pharmacokinetic modeling to support bioequivalence and approval of generic products: A case for diclofenac sodium topical gel, 1% CertaraMarch 16, 2021
IQ WG Evaluation of PBPK Models for Organ-Impaired Populations On-Demand Webinar IQ WG Evaluation of PBPK Models for Organ-Impaired Populations • The predictive performance of physiologically based pharmacokinetic(s) (PBPK) models for PK in renal impairment…CertaraMarch 10, 2021
Advancing Pediatric Drug Development Using Simcyp PBPK White Paper Advancing Pediatric Drug Development Using Simcyp PBPK CertaraMarch 4, 2021
Simcyp™ PBPK Simulator Brochure Simcyp™ PBPK Simulator Streamlines drug development by using PBPK modeling to predict drug behavior in virtual populations, optimize…CertaraJanuary 22, 2021
Liquid Biopsy Enables Quantification of the Abundance and Interindividual Variability of Hepatic Enzymes and Transporters Publication Liquid Biopsy Enables Quantification of the Abundance and Interindividual Variability of Hepatic Enzymes and Transporters CertaraNovember 13, 2020
How PBPK Modeling Can Replace Drug-Drug Interaction Studies Press Coverage How PBPK Modeling Can Replace Drug-Drug Interaction Studies Patients often take more than one drug at a time, especially elderly patients and those…CertaraNovember 12, 2020
Galderma Achieves FDA Approval of AKLIEF® (trifarotene) Case Study Galderma Achieves FDA Approval of AKLIEF® (trifarotene) In October 2019, Galderma announced that the U.S. FDA approved AKLIEF® (trifarotene) Cream, 0.005% for the…CertaraNovember 9, 2020
Danazol oral absorption modelling in the fasted dog: An example of mechanistic understanding of formulation effects on drug pharmacokinetics Publication Danazol oral absorption modelling in the fasted dog: An example of mechanistic understanding of formulation effects on drug pharmacokinetics CertaraOctober 30, 2020
PBPK modeling supports approval of breakthrough cancer drug Video PBPK modeling supports approval of breakthrough cancer drug Pharmacyclics’ (now AbbVie) Imbruvica (ibrutinib) is an anticancer drug targeting B-cell malignancies. Leveraging the US…CertaraOctober 23, 2020