C-QTc and C-QT Analysis: Replacing TQT Studies and Accelerating Cardiovascular Safety Decisions White Paper C-QTc and C-QT Analysis: Replacing TQT Studies and Accelerating Cardiovascular Safety Decisions Replace or waive TQT studies with validated C-QT analysis strategies accepted by FDA, EMA, PMDA.…CertaraOctober 3, 2025
Certara & Dizal Partner to Fast-Track FDA Approval of Sunvozertinib for Lung Cancer Case Study Certara & Dizal Partner to Fast-Track FDA Approval of Sunvozertinib for Lung Cancer Certara’s support enabled fast-track FDA oncology approval 2025 for Sunvozertinib, a breakthrough NSCLC therapy targeting…CertaraOctober 2, 2025
Pharmacokinetics, Bioequivalence, and Safety of Bromocriptine Mesylate Tablets in Healthy Chinese Subjects Publication Pharmacokinetics, Bioequivalence, and Safety of Bromocriptine Mesylate Tablets in Healthy Chinese Subjects Explore how fed‑condition crossover study confirms bromocriptine mesylate bioequivalence and safety, analysed using Phoenix WinNonlin.CertaraSeptember 29, 2025
Pharmacokinetics, Relative Bioavailability, and Safety of the SHR0302 Oral Solution and Tablets: A Single-Center, Randomized, Open-Label, Crossover (Two-Formulation, Two-Period) Phase I Trial in Healthy Chinese Volunteers Publication Pharmacokinetics, Relative Bioavailability, and Safety of the SHR0302 Oral Solution and Tablets: A Single-Center, Randomized, Open-Label, Crossover (Two-Formulation, Two-Period) Phase I Trial in Healthy Chinese Volunteers Discover how oral solution and tablet formulations of SHR0302 show comparable bioavailability and safety in…CertaraSeptember 26, 2025
ADPO: automatic-differentiation-assisted parametric optimization Publication ADPO: automatic-differentiation-assisted parametric optimization See how Automatic differentiation reduces PK/PD model runtime by up to 95% while preserving accuracy,…CertaraSeptember 22, 2025
Best practices in clinical pharmacology gap analysis Blog Best practices in clinical pharmacology gap analysis September 19, 2025 Submitting your New Drug Application (NDA) to the FDA is the ultimate…CertaraSeptember 19, 2025
Certara Launches Libra™: AI-Powered Drug-Induced Liver Injury Prediction Tool Announcement Certara Launches Libra™: AI-Powered Drug-Induced Liver Injury Prediction Tool RADNOR, Pa. – September 17, 2025 – Certara, Inc. (Nasdaq: CERT), a global leader in…CertaraSeptember 17, 2025
Redefining Every Stage of Investment (RESI) Seed to Exit Conference Redefining Every Stage of Investment (RESI) Seed to Exit –CertaraSeptember 5, 2025
The Pharmacometrics Africa Conference 2025 (PMXAC-2025) Conference The Pharmacometrics Africa Conference 2025 (PMXAC-2025) CertaraSeptember 4, 2025
Certara Biotech Forum: Workshop on Developing Investor-Ready Strategies Live Events Certara Biotech Forum: Workshop on Developing Investor-Ready Strategies – London, UKCertaraSeptember 4, 2025