Drug Development

After the lengthy process of drug discovery (identifying a target and validating a drug candidate), the process of drug development is still far from complete. Drug development includes the safety, efficacy, formulation and manufacture of the drug. Typically, safety testing begins with a series of experiments called preclinical studies. If these studies predict the drug candidate to be safe, testing begins in humans in a series of studies called clinical trials.

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BIOFACT:
A crucial component of initiating a clinical trial is recruiting study subjects who agree to participate and sign a document called informed consent. Potential subjects must be informed about all aspects of the study before they decide to participate. Participants can withdraw their informed consent at any time.