Are In Vitro Metabolism and DDI Studies Critical for an Investigational New Drug Application?

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Drug metabolism and drug-drug interaction (DDI) studies often take a back seat to toxicity studies when preparing for an IND. Cross-species metabolite identification and plasma protein binding are typically considered sufficient for an IND. However, benefits to drug development efficiency and expense along with modern regulatory expectations are causing many to look deeper earlier.

Metabolism studies, often referred to as ADME (Absorption, Distribution, Metabolism, Excretion), can help bridge in vivo data to clinical outcomes. Furthermore, guidance documents from regulatory bodies indicate that DDI studies should be done before clinical studies to ensure that drug will not only be effective in the therapeutic manner prescribed, but also be safe and not bring any undo harm to patients. If you are involved in the development of potential new therapeutics, this discussion will help you gain necessary knowledge to inform your drug development decisions.

Key Topics Include:
How drugs are metabolized
Safety testing required to move a drug through IND and into clinical trials
When to conduct ADME studies in pre-clinical species
Common pitfalls and areas of concern: proper design and interpretation