Research organizations, drug

R D Focus. This database service [66] provides information on over 7000 drugs in active development. The service monitors the development, efficacy, and status of pharmaceuticals from early clinical testing through to launch. Data are gathered through direct contact with manufacturers and research organizations. It appraises both the scientific and commercial aspects of drug development and is searchable by product, by phase, by mechanism of action, and by country. R D Focus product is commercially available in several formats. 

Contract Research Organizations Role and Function in New Drug Development F. Richard Nichol 407... 

A dimension of the increasing disintegration of pharmaceutical R D is the growing use of contract research organizations (CROs) to conduct clinical trials of new drugs. By 1999, 23% of trials were outsourced to CROs (Azoulay 2004, pp. 1593,1600). In general, the more data-intensive projects are outsourced, while knowledge-intensive projects are more frequently undertaken within pharmaceutical companies (p. 1592). 

Cockburn, Iain M., and Rebecca M. Henderson. 1998. Absorptive Capacity, Co-Authoring Behavior, and the Organization of Research in Drug Discovery. Journal of Industrial Economics 46 157-182. 

The test facilities in India and China have evolved over the years and conduct a range of nonclinical safety assessment studies for in-house drug development, and also provide service as contract research organizations (CROs) for sponsors not only from India and China but also from overseas pharmaceutical and agrochemical companies. 

During the 1990 Washington Conference on Analytical Methods Validation Bioavailability, Bioequivalence and Pharmacokinetic Studies [1], parameters that should be used for method validation were defined. The final report of this conference is considered the most comprehensive document on the validation of bioanalytical methods. Many multinational pharmaceutical companies and contract research organizations contributed to its final draft. This scientific meeting was sponsored by the American Association of Pharmaceutical Scientists (AAPS), the Association of Official Analytical Chemists (AOAC), and the U.S. Food and Drug Administration (FDA). The conference report has been used as a reference by bioanalytical laboratories and regulatory agencies worldwide. 

Outsourcing strategies offer a highly flexible and adaptable strategy for clinical development support. This approach to drug development generally involves the use of contract research organizations (CROs) and contract analytical laboratories, which perform a variety of specialized clinical development-based functions. This practice has... 

Nichol, F.R., 2006, Contract research organizations Role and function in new drug development. In Smith, C.G. and O Donnell, J.T. (Eds), The process of new drug discovery and development, 2nd Edition, Informa Healthcare, 407-418. 

---