Computers in the new drug application process.
J Chem Inf Comput Sci
; 33(1): 86-94, 1993.
Article
en En
| MEDLINE
| ID: mdl-8440756
Before a company can introduce a new pharmaceutical in the United States, it must receive approval of a New Drug Application (NDA) from the Food and Drug Administration. As a document that may consist of over 100,000 pages, the NDA presents the company's evidence that the new pharmaceutical is safe and effective for treating a particular medical condition. This paper describes four major issues in the NDA process: the role of computers in the FDA review, standards for compound documents and data, substitution of computer-assisted new drug applications (CANDAs) and electronic versions of other documents for paper versions, and management of the heterogeneous collection of material on which an NDA is based.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Computadores
/
Aprobación de Drogas
País/Región como asunto:
America do norte
Idioma:
En
Revista:
J Chem Inf Comput Sci
Año:
1993
Tipo del documento:
Article
Pais de publicación:
Estados Unidos