Machine Learning for PK/PD Modeling in Drug Development
Pharmacometricians can use machine learning for PK/PD modeling to help them characterize the safety and…
Danielle Pillsbury2025年3月4日
How the US FDA MIDD paired pilot program helps sponsors
2025年2月28日 For the past couple of decades, leading American institutions, pharmaceutical and biotechnology…
Danielle Pillsbury2025年2月28日
Measuring metabolites in index clinical DDI studies
2025年2月7日A key drug development safety consideration is whether the drug candidate will interact…
Danielle Pillsbury2025年2月7日
Why FDA’s omaveloxolone approval for Friedreich’s ataxia matters
2025年1月10日 Friedreich’s Ataxia (FA) is a rare, genetic, and progressive neurodegenerative disorder. A…
Danielle Pillsbury2025年1月10日
Key development considerations for cell therapies
2024年12月5日 What is a “cell therapy”? Nearly every recent oncology clinical conference has…
Becca Bucci2024年12月5日
De-risking Drug Development: Key Chemistry, Manufacturing, and Controls (CMC) and Physiologically Based Pharmacokinetic (PBPK) Approaches in Early Development
2024年11月22日 In drug development, early strategic planning is crucial to minimizing risks, optimizing…
Danielle Pillsbury2024年11月22日
Shining a spotlight on Clinical Study Software at the 2024 Pinnacle 21 Enterprise User Group Meeting
Shining a spotlight on Clinical Study Software at the 2024 Pinnacle 21 Enterprise User Group Meeting
On 2024年10月30日, we hosted our Pinnacle 21 Enterprise (P21E) User Group Meeting (UGM)…
Danielle Pillsbury2024年11月12日
Why Clinical Pharmacology & Pharmacometrics Should Collaborate
A symbiosis between a modeler and a trialist is often required to develop a model-informed…
Danielle Pillsbury2024年11月8日
