Model-based meta-analysis (MBMA) helps sponsors to make the wisest, most informed decisions about the next steps in their drug’s development and market positioning.
Biologic drug development is a rapidly evolving sector in the biopharmaceutical industry. Immunogenicity is an inherent challenge with this complex class of drugs. A quantitative systems pharmacology approach can be used to predict and better manage immunogenicity, and as a tool to guide clinical and regulatory decision-making in biologics drug development.
In this webinar, Dr. Adam Darwich, Certara Lecturer in Precision Dosing at the Manchester Pharmacy School at The University of Manchester, presented several case studies that illustrate how PBPK models have been used to predict drug-drug interactions, extrapolate to special populations, and optimize clinical study design.
Making the right choices in drug development often means the difference between getting a new medication to patients and it ending up in the scrap heap of failed programs. 承認された医薬品および開発中の医薬品の両方に関する公開情報は非常に多く存在します。こうした状況下で、スポンサー企業はどのように臨床試験データに基づいて、開発医薬品の成功への道筋をつける知見を獲得することができるでしょうか？
A small pharma company leveraged Certara’s consulting services to predict the effects of organ impairment on exposure for a new drug formulation.
Certara’s modeling strategy provided a sponsor compelling support for positive efficacy signal of an in-licensing candidate, helping to secure financing.