[From the chemical product to the authorization of drug marketing].
A great number of highly qualified specialists are involved in the drug development process, mainly chemists, galenic and pharmacokinetic experts, pharmacologists and toxicologists. The 7 to 15 years development process implies preclinical studies in thousands of animals as well as clinical studies in about 3,000 patients. Various mandatory studies, regulatory requirements as well as a drug assessment process lead to the possible marketing authorization approval. The drug assessment process usually leads to a sound assessment of pharmaceutical quality of clinical benefit in each indication proposed; yet, occasionally, the assessment of safety is incomplete. Performing phase IV studies, collecting pharmacovigilance data is a requirement in the future. The prescriber of a newly approved drug must remain highly watchful.
Caulin
Charles
C
Service de médecine interne A Hôpital Lariboisière, 75475 Paris. charles.caulin@lrb.ap-hop-paris.fr
D000818:Animals; D002986:Clinical Trials as Topic; D017277:Drug Approval; D015195:Drug Design; D004353:Drug Evaluation, Preclinical; D004345:Drug Industry; D006801:Humans; D007400:Interprofessional Relations; D008389:Marketing of Health Services