医薬品開発が進むにつれ、規制当局は、製品が体内でどのように代謝されるのか、また、重要な臓器に残留する可能性のある化合物に関連するリスクを明確に示すよう義務付けています。
Renal impairment studies are a challenging area to recruit, especially for moderate and severe subjects. Therefore, making informed decisions about the design of protocols is key, as overly complex protocols can quickly narrow the patient population.
This webinar will drawer on experiences from both the site and CRO perspectives to inform sponsors to how protocols might be better written to maximize patient enrollment opportunities, balancing the practicalities of achieving study goals whilst also satisfying the needs of regulatory bodies around the world.
The webinar will discuss observations from the presenters’ collective history of working with regulators in this area to help guide design decision making to successfully enroll patients and keep your drug development on track.
Learnings:
Understand design considerations around mild, moderate and/or severe populations, and the resulting implications for recruitment
Challenge thinking on what a "typical" patient looks like? From GFR estimates to cholecystectomies - how to avoid assumptions that inadvertently limit patient populations
Avoid mistakes on protocol inclusion and exclusion criteria
Learn from the presenters collective experience of what regulators are looking for when conducting impairment studies
Reflect on some of the key points in the FDA Draft Guidance “Guidance for Industry Pharmacokinetics in Patients with Impaired Renal Function- Study Design , Data Analysis, and Impact on Dosing”
