Good clinical practice (GCP) seen in all except
Preclinical trials Good clinical practice (GCP) guidelines are for clinical trials (Phase I, Phase II, Phase III and Phase IV). These guidelines (GCP) are laid down after completion of preclinical study. When a compound deserving trial in man is identified by animal studies (priclinical suties), the regulatory authorities are approched who on satisfaction issue an investigational new drug (IND) licence. Standards for the design, ethics, conduct, monitoring, auditing, recording and analyzing data and repoing of clinical trials have been laid down in the form of Good clinical Practice (GCP) guidelines by an International conference on Harmonization (ICH). Stages in new drug development . Synthesis / isolation of the compound : (1-2 years) . Preclinical studies : screening, evaluation, pharmacokinetic and sho-term toxicity testing in animals : --> (2-4 years) . Scrutiny and grant of permission for clinical trials : --> (3-6 months) . Pharmaceutical formulation, standardization of chemical/ biological/immuno-assay of the compound : -4 (0.5-1 year) . Clinical studies : phase I, phase II, phase III trials; long-term animal toxicity testing : --> (3-10 years) . Review and grant of marketing permission : --> (0.5-2 years) . Postmarketing surveillance : -4 (phase IV studies) A) Approches to drug discovery (Synthesis / isolation of compound) . Sources of drug synthesis: - Natural sources - Chemical synthesis - Rational approch - Molecular modelling - Combinatorial chemistry - Biotechnology (recombinant DNA technology) B) Preclinical studies After synthezing a compound, it is tested on animals to expose the whole pharmacological profile. Following tests are performed - Screening tests - Tests on isolated organs, bacterial cultures etc - Tests on animal models of human disease - General observational test - Confirmatory tests and analogous activities - Mechanism of action - Systemic pharmacology - Quantititative tests - Pharmakokinetics - Toxicity tests C) Scruting and grant of permission for clinical trials When a compound deserving trial in man is identified by animal studies, the regulatory authorities are approched who on satisfaction issue an investigational new drug (IND) licence. Standards for the design, ethics, conduct. monitoring, auditing, recording and analyzing data and repoing of clinical trials have been laid down in the form of "Good clinical Practice (GCP)" guidelines by an International conference on Harmonization (ICH). D) Clinical trials Phase I (Human pharmacology and safety) Phase II (Therapeutic exploration and dose ranging) Phase Ill (Therapeutic confirming) Phase IV (Postmarketing surveillance)
Preclinical trials
Phase I trials
Phase II trials
Phase IV trials