Category: ホワイトペーパー
The Importance of Collecting Race/Ethnicity Information in Clinical Trials for Biologics – A Clinical Pharmacology Perspective
Using Real-world Evidence to Advance Market Access for New Therapeutics
FDAのデジタル変革の旅
臨床的にバリデーション済みのIn Silicoモデリング & シミュレーション (M&S) による免疫原性の予測と投与量の最適化
Simcyp Simulator™を使用した仮想生物学的同等性（VBE）の証明
Demonstrating bioequivalence (BE) remains the key regulatory hurdle for genericdrug approval. As a result, some branded drugs remain on the market well pastthe originator’s patent expiration, without cost-effective generic alternatives thatcould benefit patients. Model-informed drug development (MIDD), specificallyphysiologically-based pharmacokinetics (PBPK) leveraging in vitro data, is a proven,cost-effective option to consider in lieu of running an … Continued
Health Canada Regulatory Modernization: Yesterday, Today, And Tomorrow
Advancing Pediatric Drug Development Using Simcyp PBPK
Leveraging Biosimulation to Inform Optimal Use of COVID-19 Vaccines
By: Dr. Piet van der Graaf, SVP
“Where do I start?”: Strategies for selecting the first dose for human clinical trials
This guide to dose selection for first-in-human studies explains the conceptual framework, methods, and tools for extrapolating in vitro and animal study data to humans.
