The study of preclinical development of the drug involves in vitro studies and often trials on various animal populations are done, different dosage of the compounds is introduced into the cell line or animal in order to obtain the rate of efficiency at the primary stage and information about its metabolism, absorption, excretion and utilization in the body.
Five different forms of clinical trials are done for a drug to be successful:
a) Treatment trials- test experimental treatments or a new combination of drugs.
b) Prevention trials- look for ways to prevent a disease or prevent it from returning.
c) Diagnostic trials- find better tests or procedures for diagnosing a disease.
d) Screening trials- test methods of detecting diseases.
e) Quality of life trials- explore ways to improve comfort life for individuals with a chronic illness.
Clinical trials of a drug are carried out in five phases:
a) Phase 0- designed to expedite the development of promising therapeutic agents.
b) Phase I- a small group of healthy volunteers are selected to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a therapy. Volunteers are given single ascending dose (SAD), multiple ascending dose (MAD) and the effect of before and after meal is also monitored. Approximately 80 % drugs fail in phase I.
c) Phase II- performed on larger groups and are designed to assess the activity of the therapy, and continue phase I safety assessments.
d) Phase III- randomized controlled trials on large patient groups aimed at being the definitive assessment of the efficacy of the new therapy.
e) Phase IV- post-launch safety monitoring and ongoing technical support of a drug.
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