Good practice is NOT needed in which phase of clinical trial:
(Ref: Sharma & Sharma 3rd ed. P 101)Clinical Trial: Systemic study of a new drug in human subject to generate data for pharmacological and adverse effects with an aim to determine safety and efficacy.The procedures followed during the trial should comply with an elaborate code known as "Good clinical practice (GCP)" prescribed by international conference on Harmonization.GCP provide details about:#Designing the trial#Collection of the data#Recording of information#Statistical analysis#Documentation and reporting the results of clinical trialsPRECLINICAL EVALUATION PHASE (ANIMAL STUDIES)Animals studies are done initially in order to define the pharmacological profile of lead compoundAim: Satisfy all requirements that are needed before a compound is considered fit to be tested for first in humansIt is done according to formal operating code known as "Good Laboratory Practices"Good laboratory practices ensures reliability and reproducibility of laboratory data and minimises human errorsDuration of preclinical study: 2 yearsOut of 10,000 compounds screened during preclinical phase, only 10 qualify, which are then subjected to clinical trial in humans.
Preclinical stage
Phase 2
Phase 3
Phase 4
General Pharmacology