Standard Drug File

B-94MI 410-02 The DERWENT Standard Drug File of Known Drugs." Derwent, London, 1994. 

Consideration (figure 2) of both a Standard Drug File (24082 entries) and a Pharmaprojects dataset (5279 entries) shows that drug-like molecules have a normal distribution, with a modal value of around 2.5, and a LogP of 5.0 is indeed a reasonable upper bound for a candidate drug molecule. 

A module of the CHEM-X modelling system (see modelling section). Storage and retrieval of two- and three-dimensional structures with substructure-search capability. Available databases include Chapman Hall Dictionary of Drugs (15,000 compounds). Chapman Hall Dictionary of Fine Chemicals (120,000 small organics). Chapman Hall Dictionary of Natural Products (54,000), Derwent Standard Drug File (31,000 biologically active compounds), ChemReact (370,000 reaction types) and others. 

When an NDA comes in, the FDA has 60 days to decide whether to file it so that it can be reviewed. The FDA can refuse to file an application that is incomplete. For example, some required studies may be missing. In accordance with the Prescription Drug User Fee Act (PDUFA), the FDA s Center for Drug Evaluation and Research (CDER) expects to review and act on at least 90 percent of NDAs for standard drugs no later than 10 months after the applications are received. The review goal is six months for priority drugs. (See The Role of User Fees. )... 

Data from HPLC, MS, NMR and IR have to be stored in standard analytical file formats and transferred to a generic data viewer connected to standard databases that are valuable in drug discovery. 

Friedman, H.L. (1951) Influence of isosteric replacements upon biological activity. National Academy of Sciences-National Research Council Publication No. 206, Washington, DC, pp. 295-395. Thornber, C.W. (1979) Isosterism and molecular modification in drug design. Chemical Society Reviews, 8, 563-580. Hall, S.R., Allen, F.H., and Brown, I.D. (1991) The crystallographic information file (CIF) a new standard archive file for crystallography. Acta Crystallographica A, 47, 655-685. 

The BLA was established pursuant to the Food and Drug Administration Modernization Act of 1997, consolidating a prior requirement for two applications a Product License Application and an Establishment License Application. The final implementing rule reduced the amount of information a manufacturer is required to file in its BLA application and shifted responsibility to the plant inspection process to ensure that manufacturers complied with cGMP standards. 

Analytical reagents used in testing the excipients should be prepared and labeled following established procedures. Retest or expiration dates should be used, as appropriate, for analytical reagents, or standard solutions. Analytical methods should be validated unless the method employed is set forth in the current revision of the United States Pharmacopeia/National Formulary, Association of Official Analytical Chemists (AOAC), Book of Methods, or other recognized standard references, or detailed in the Drug Master File or approved New Drug Application and are used unmodified. 

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