今日、臨床薬理情報は医薬品添付文書の50％以上を占めています。不完全な臨床薬理学開発プログラムは、審査期間中にスポンサーに重大な問題を引き起こしたり、販売申請の承認可否に影響を与える可能性があります。製造販売承認申請の効率的な臨床薬理学審査には、開発計画の早期かつ思慮深い検討、必要な臨床試験の適時実施、モデルを活かした医薬品開発（MIDD）アプローチによる利用可能な臨床データの最大化、そして全情報の正確な伝達が求められます。
As former FDA and EMA regulators, the Certara Clinical Pharmacology Regulatory Strategy Team has extensive understanding of the requirements for fit-for-purpose clinical pharmacology drug development programs. The objective of this webinar is to review the clinical pharmacology-related regulatory hurdles across regions that may lead to review issues or impact approvability of marketing applications and discuss strategies to mitigate these.
The team will discuss common issues that have impacted or delayed approvability in EU and US applications using illustrative case examples. The issues covered are dose selection, adequate pharmacokinetic (PK) data in target populations, adequate absorption distribution metabolism excretion (ADME) characterization and labeling recommendations for intrinsic and extrinsic factors, formulation changes, QT prolongation issues, and bioanalytics.
How did inadequate information impact regulatory decision-making and review outcomes in each case? What can we learn from others’ experience? In addition, commonly asked questions that arise for global programs with a focus on Japan and China will be presented.
By attending this webinar, you will learn.
- How overly minimalistic clinical pharmacology documentation can jeopardize your drug’s approvability.
- Regulatory perspectives on gaps in clinical pharmacology knowledge and how those impact risk-benefit assessments
- Mitigation strategies to achieve a streamlined clinical pharmacology strategic plan.
