Non-Clinical Drug Development

• Non-clinical (preclinical) drug development involves laboratory and animal studies conducted to assess a drug’s safety, pharmacology, and pharmacokinetics before human trials.

Key Components of Non-Clinical Drug Development:

Pharmacology Studies

• Primary Pharmacodynamics: Assess therapeutic effects on intended target.

• Secondary Pharmacodynamics: Investigate effects unrelated to therapeutic target.

• Safety Pharmacology: Evaluate adverse effects on vital systems (cardiovascular, respiratory, CNS).

Pharmacokinetics (PK) and ADME Studies

• Absorption: Entry into circulation.

• Distribution: Dispersion throughout the body.

• Metabolism: Chemical alterations in the body.

• Excretion: Elimination of drug and metabolites.

Toxicology Studies

• Acute Toxicity: Effects after a single dose.

• Subacute/Subchronic Toxicity: Effects after repeated dosing over short-to-medium durations.

• Chronic Toxicity: Long-term exposure effects.

• Genotoxicity, Carcinogenicity, Reproductive Toxicity, Immunotoxicity: Assess potential genetic, cancerous, reproductive, and immune effects.

In Vitro Studies

• Cell-based Assays and Receptor Binding: Test effects on cells and receptor interactions.

Animal Models

• Species Selection: Rodents and non-rodents.

• Dose and Study Design: GLP-compliant studies with ethically determined doses.

Regulatory Guidelines

• Good Laboratory Practice (GLP): Ensures data quality.

• ICH Guidelines: International standards for non-clinical studies (e.g., ICH M3(R2)).

Objectives of Non-Clinical Studies

• Safety Assessment: Identify toxicities and establish safe starting doses.

• Efficacy Prediction: Show pharmacological activity supporting therapeutic potential.

• Regulatory Compliance: Provide data for regulatory submissions (e.g., IND application).

Non-clinical studies form a critical foundation for assessing a drug’s safety and potential efficacy prior to human trials.