Preclinical Evaluation Phase

• Preclinical evaluation phase tests drug safety and efficacy in lab and animal studies before human trials.
• This phase tests the lead compound in non-human subjects (cells and animals) to assess its safety, effectiveness, and behavior in the body.

Major Objectives of Preclinical Evaluation Phase:

• Evaluate safety and toxicity
• Study pharmacokinetics (PK): what the body does to the drug
• Study pharmacodynamics (PD): what the drug does to the body
• Collect data to support an IND (Investigational New Drug) application for human trials

Types of Preclinical Studies:

1. In Vitro Studies

• Conducted in test tubes or petri dishes using cell cultures
• Assess cellular effects, target binding, and basic toxicity

2. In Vivo Studies

• Conducted in animals (usually one rodent and one non-rodent)
• Includes:
  • Acute toxicity: Single high dose
  • Sub-chronic/chronic toxicity: Repeated dosing
  • Carcinogenicity, mutagenicity, teratogenicity: Risk of cancer, mutations, or birth defects
  • PK/PD studies: Absorption, bioavailability, half-life, etc.

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