Pharmaceutical Development Report

Research reports—Research reports such as stability reports, method validation and transfer reports, and pharmaceutical development reports are key documents used for NDA/MAA filings. These documents are strictly version controlled. 

Normally, a pharmaceutical development report is written in the United States, which should be available at the time of Pre-Approval Inspection (PAI). The development report contains the choice of excipients, their purpose and levels in the drug product, compatibility with other excipients, drug or package system, and how they may influence the stability and efficacy of the finished producf. 

Physicochemical characterization techniques are beginning to play a major role in the drug development process because they help us to understand the mechanism of drug delivery. Demonstration of this understanding is expected by the regulatory agencies and is usually an important component of the pharmaceutical development report. 

Rhodium-catalyzed diazo insertions, known since 1976, have been extensively reviewed39. The first report40 indicated that rhodium acetate efficiently catalyzes diazo insertion into an alkene, giving the cyclopropane. Rhodium-catalyzed intramolecular C-H insertion was first observed by workers at Beecham Pharmaceuticals, who reported that 1, on exposure to a catalytic amount of rhodium acetate, cyclizes cleanly to the /1-lactam41. This approach to thienamycin derivatives has been developed further by these workers42,43. 

In addition, during 2001 we interviewed approximately 64 individuals in DoD, FDA, the pharmaceutical industry, academia, and related organizations. A list of those interviewed can be found at the end of the report. Within FDA, we interviewed officials in the Center for Biologics Evaluation and Research (CBER), which has primary responsibility for vaccines and other biologics. We also interviewed officials in the Center for Drug Evaluation and Research (CDER), the larger of the two centers, which has responsibilities for pharmaceutical drugs. In the private sector, we interviewed individuals in both the pharmaceutical development industries and in the for-profit and not-for-profit pharmaceutical E T establishment. 

The Human Development Report 2001 reveals that under pressure from Europe and the usa developing countries fear that they may lose foreign investors if they legislate for or use compulsory licenses (undp, 2001). In addition, developing countries also lace the threat of long, expensive litigation brought by pharmaceutical companies. 

TABLE 21-4. Summary of SMB Separations Reported in the Literature (Only Enantiomeric Separations on CSP and Purification of Intermediates and Drug Substance in Pharmaceutical Development)... 

---