Preclinical Regulation
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Preclinical Regulation – Overview
Preclinical regulation refers to the rules, guidelines, and standards governing the non-human testing phase of drug and medical product development. This phase evaluates a drug’s safety, efficacy, and pharmacological profile before human trials begin. Regulatory authorities ensure that preclinical studies are conducted ethically, scientifically, and with quality assurance.
Objectives of Preclinical Regulation
To protect human participants by ensuring only safe candidates proceed to clinical trials.
To ensure scientific validity of safety and efficacy data.
To standardize methods and reporting of toxicological and pharmacological studies.
To enable regulatory review and approval for investigational new drugs (IND).
Key Components of Preclinical Studies
Pharmacodynamics (PD)
How the drug affects the body.
Pharmacokinetics (PK)
Absorption, distribution, metabolism, and excretion (ADME).
Toxicology Studies
Acute, subacute, and chronic toxicity.
Genotoxicity, carcinogenicity, reproductive toxicity.
Safety Pharmacology
Impact on vital systems (cardiovascular, respiratory, CNS).
Formulation Development
Drug composition, dosage form, and stability.
