Databases clinical development

Phase IV trials are conducted as postmarketing efforts to further evaluate the characteristics of the new drug with regard to safety, efficacy, new indications for additional patient populations, and new formulations. Phase IV is generally used to characterize all post-NDA/BLA clinical development programs. However, some organizations use Phase IV to describe only FDA-requested clinical trials and use Phase V to describe internally motivated market expansion trials (e.g., new indications, new formulations, updated safety databases). 

A Clinical Summary is to start with a subsection on Biopharmaceutical Studies, and Associated Analytical and Bioanalytical Chemistry Methods conducted during the clinical development of a drug candidate. The background of the formulation development process is to be briefly provided and is to include information on in vitro and in vivo dosage form performance and the general approach and rationale for developing the bioavailability (BA), comparative BA, bioequivalence (BE), and in vitro dissolution profile database. Also to be included is a summary of the analytical and bioanalytical chemistry methods and the validation characteristics of these methods. 

Notes Several commercial databases still list RSV vaccines and antiviral in clinical development by companies, e.g., Wyeth, Sanofi Aventis, and Glaxo Smith Kline. These projects are considered discontinued as companies websites do not list any active RSV projects or there has been no new information for the past 3 years after completion of phase II or III trials. 

FIGURE 25.2 (a) Increase in MW over time of published medici-nai compounds, (b) Mean MW through clinical development (Source Investigational Drugs Database). Similar results found by Blake and Wenlock et al . The increase in MW between discovery compounds (leads) and preclinical compounds (candidates) has been studied in detaii by Oprea et... 

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