The transition from preclinical to clinical phases of medicinal product development is a critical step in bringing a new pharmaceutical product to the market. Optimizing this step is essential to ensure a smooth and successful progression of your drug candidate.
Before initiating clinical trials, you should be confident that your preclinical data is thorough and robust. This data should provide a strong scientific basis for moving forward, including evidence of safety and efficacy. The transition from preclinical to clinical phases of drug development is regulated by various guidelines and regulatory frameworks in different regions. Especially, particular attention should be paid to ICH M3(R2) “Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals” and EMA guideline “Strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products”. Depending on the therapeutic area of the medicinal product, disease-specific guidelines or initiatives may also provide additional guidance.
A good strategy that helps to optimize this critical phase of drug development is a meeting with regulatory authorities. Early and ongoing dialogue with regulatory experts and regulatory agencies, such as FDA or EMA, or EU Member State national Competent authorities can strengthen and optimize your development plan and ensure a smooth transition from preclinical to clinical phases while complying with all regulatory requirements.
STARoDuB team can support you in navigating this complex process effectively. Don’t hesitate tocontact us.
