Drug Reasonably Safe for FIH Trials

The topic of preclinical assessment of a clinical candidate has been reviewed in Chapter 29. The topic is mentioned here because the decision as to whether it is safe to take a candidate drug into humans is ultimately a medical judgment that can only be made by individuals responsible for clinical drug development. Preclinical safety assessments are designed to provide the knowledge needed to decide whether it is reasonably safe to study a drug candidate in humans. The term reasonably safe is used in this context because that is what an FDA reviewer must answer when reviewing an IND application. 

Two simple questions can be asked to help decide if a candidate drug is ready to be studied in Phase I FIH trials  

Based on the preclinical data we have, would I be willing to roll up my sleeve and be the first to receive this drug  

If the answer is yes to both questions the development team is ready to prepare an IND or a CTA (Clinical Trial Application) application the European equivalent of an IND to request permission to begin a clinical trial program. 

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