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
Modeling and simulation in pediatric drug development Press Coverage Modeling and simulation in pediatric drug development Published: December 21, 2023 This is the article written in German, published on pharmind. Children's…CertaraDecember 21, 2023
American College of Toxicology 2025 Annual Meeting Conference American College of Toxicology 2025 Annual Meeting – – BoothCertaraMay 24, 2023
Translational Pharmacology Consulting Supports Combination Therapy for Treating Pulmonary Mycobacterium Avium Complex Disease Case Study Translational Pharmacology Consulting Supports Combination Therapy for Treating Pulmonary Mycobacterium Avium Complex Disease RedHill Biopharma Ltd., a specialty biopharmaceutical company, developed RHB-204, a treatment for MAC, and needed…CertaraMay 9, 2023
Therapeutic Proteins’ Drug-Drug Interactions: Updates & Challenges On-Demand Webinar Therapeutic Proteins’ Drug-Drug Interactions: Updates & Challenges Therapeutic proteins (TP) - and more specifically monoclonal antibodies - are part of the therapeutic…CertaraDecember 5, 2022
Why you should select your drug formulation before starting clinical studies Blog Why you should select your drug formulation before starting clinical studies Drug developers often rush through the discovery process to get into human testing. Most are…CertaraOctober 28, 2022
3 Takeaways from the FDA Oligo Guidance You Need to Know Blog 3 Takeaways from the FDA Oligo Guidance You Need to Know In June 2022, the FDA published their first oligonucleotide clinical pharmacology specific guidance . This…CertaraSeptember 23, 2022
The Essential Components of Your Drug’s Biomarker Strategy White Paper The Essential Components of Your Drug’s Biomarker Strategy CertaraJanuary 14, 2022