What is the Origin of Preclinical Evaluation?

The concept is foundational to modern drug regulation, formalized after historical incidents demonstrated the need for rigorous safety testing prior to human exposure. The term 'preclinical' literally means "before the clinic," establishing the non-human testing phase as a critical safety gate.

What is the Mechanism of Preclinical Evaluation?

The evaluation mechanism focuses on establishing a No-Observed-Adverse-Effect Level (NOAEL) and determining the therapeutic window. Pharmacodynamic studies elucidate the drug's interaction with its target receptor, such as a steroid hormone receptor, while toxicology studies assess acute and chronic organ damage. This systematic process provides the scientific rationale and safety data necessary to justify the transition to human clinical trials.

Preclinical Evaluation

Meaning

Preclinical Evaluation is the mandatory phase of research and development for a new drug or therapeutic agent that occurs before any testing in human subjects is initiated. This evaluation involves in vitro (cell culture) and in vivo (animal model) studies to determine the compound’s pharmacological activity, efficacy, toxicity profile, and preliminary pharmacokinetic parameters. Successful completion of this phase is required to submit an Investigational New Drug (IND) application to regulatory bodies.