Effective Study Design and Execution of Renal and Hepatic Impairment Trials Webinar скачать в хорошем качестве

Effective Study Design and Execution of Renal and Hepatic Impairment Trials Webinar

Watch this webinar to learn how to effectively manage renal and hepatic impairment trials by leveraging site expertise, enhancing communication and utilizing advanced clinical pharmacology tools. Discover how DVCR supports renal and hepatic impairment clinical trials. Renal: https://drvince.com/cro/early-phase-s... Hepatic: https://drvince.com/cro/early-phase-s... Learn more about DVCR: https://DrVinceCRO.com 0:00 Introduction 3:48 Keys to Successfully Managing Organ Impairment Trials 4:54 Current Challenges 6:15 Key Considerations for CROs 7:15 Site-Centric Model: Key Benefits 8:22 Key Considerations for Success 9:30 How Do We Grow? 9:57 Renal and Hepatic Patients 16:18 Protocol Recommendations 18:02 CRO and Site Requirements 20:07 Renal Insufficiency 21:59 Frequently Encountered Abnormal Labs 26:25 Hepatic Insufficiency 27:16 Liver Function Tests 29:00 Leveraging Clinical Pharmacology to Reduce Patient Burden 30:22 Dedicated Hepatic Impairment Study Considerations 32:26 Reduced and/or Adaptive Design 33:00 Hepatic Impairment Adaptive Design Examples 34:34 Renal Impairment Adaptive Design Examples 35:34 Physiologically-Based Pharmacokinetic (PBPK) Modeling 38:30 Q&A 50:37 Outro