Postmarketing approval, clinical trials

Contracting out of activities previously only conducted in-house is already becoming quite common and will probably continue to develop. In the past a so-called full-service pharmaceutical company took direct responsibility for all the activities required for the formulation, manufacture, quality control, and regulatory approval of its drug products. Nowadays the use of specialist contract houses to perform activities such as formulation, analytical methods development, manufacture of clinical trials supplies, supervision of the assembly of an NDA, postmarketing surveillance, and even troubleshooting may be contracted for even by some of the largest companies. 

Phase rv clinical trials are postmarketing approval trials to monitor the efficacy and side effects of the drug in an uncontrolled real-life situation. This is... 

The Ministry of Health, Labour and Welfare is the governmental body responsible for enacting legislation for pharmaceutical affairs. The regulation of clinical trials and new drug approval in Japan is based on the Pharmaceutical Affairs Law and related ordinances. The objective of the Ministry is to secure a safe medical environment through a consolidated structure of accurate reviews of pharmaceuticals and medical devices and postmarketing safety measure implementation. 

Demonstration of safety Premarket approval required Testing in animals Phase I/II/III clinical trials Post marketing surveillance system Manufacturer must meet OTC monograph standards 1 Premarketing approval or postmarketing surveillance not required Citation of existing literature... 

Alosetron was withdrawn from the U.S. market in 2000 due to serious adverse effects including severe constipation and ischemic colitis that did not appear in the initial clinical trials. Its use is now limited to an FDA-approved restricted use program in lower initial doses, and requires extensive postmarketing surveillance. Results of these trials are necessary to definitively determine alosetron s true safety profile, especially with regard to its association with or causation of fatal ischemic colitis. 

Post-market approval medical affairs—this involves the promotion of each product bymarketing and sales functions and the oversight of this process by pharmaceutical physicians. Two other critical postmarketing components are first, continued learning about the safety and efficacy of the product in normal medical practice, as opposed to clinical trials and second, the development of new or improved uses of the product as more is learned about it and as medical science moves on. The former of these two functions is termed pharmacovigilance and the latter product evergreening . 

---