What is a global risk mitigation plan & how can you use it to ensure a successful drug launch? Blog What is a global risk mitigation plan & how can you use it to ensure a successful drug launch? A Global Risk Mitigation Plan (GRMP) is a critical step in drug development as it…CertaraMay 4, 2023
FDA’s Project Optimus Guidance: Highlights and Tips for Success for Oncology Drug Developers Press Coverage FDA’s Project Optimus Guidance: Highlights and Tips for Success for Oncology Drug Developers 2023 guidance from FDA on dosages in oncology provides further context on expectations with Project…CertaraMay 3, 2023
Innovating sales & marketing digital engagement for pharma and med tech Blog Innovating sales & marketing digital engagement for pharma and med tech The regulatory environment for Pharma and Med Tech creates business challenges for digital engagement. Many…CertaraApril 21, 2023
Transforming Trial Success: AI’s Role in Clinical Trial Meta-Analysis On-Demand Webinar Transforming Trial Success: AI’s Role in Clinical Trial Meta-Analysis Published research and literature-based content holds valuable insight that can inform clinical trial execution and…CertaraApril 19, 2023
Antibody-drug Conjugates in the Clinic: Key Considerations & the Role of Modeling in Expediting Development On-Demand Webinar Antibody-drug Conjugates in the Clinic: Key Considerations & the Role of Modeling in Expediting Development Antibody-Drug Conjugates (ADCs) can be an ideal drug treatment for cancer because they deliver a…CertaraApril 17, 2023
Considerations for pricing & formulary access for DRG-funded hospital drugs Blog Considerations for pricing & formulary access for DRG-funded hospital drugs In the United States, treatments or medical services that require the patient be admitted into…CertaraApril 6, 2023
Using Quantitative Systems Pharmacology Modelling to Accelerate Drug Development Press Coverage Using Quantitative Systems Pharmacology Modelling to Accelerate Drug Development Model informed drug development (in silico modelling) continues to be a game changer in accelerating…CertaraMarch 29, 2023
Model-Informed Drug Development (MIDD) – EMA’s Advancement Press Coverage Model-Informed Drug Development (MIDD) – EMA’s Advancement Modelling and simulation (M&S) plays a crucial role in drug development. It allows information from…CertaraMarch 29, 2023
Advancing Biopharmaceutics & Drug Formulation Using In Silico Modeling White Paper Advancing Biopharmaceutics & Drug Formulation Using In Silico Modeling Model-Informed Formulation Development (MIFD) Increases Speed and Certainty for New and Generic DrugsCertaraMarch 22, 2023