DEVELOPMENT AND SUBMISSION OF A NONCLINICAL (PHARMACOLOGY TOXICOLOGY)CANDA

The experience with the submission of a nonclinical (pharmacology and toxicology) computer-assisted New Drug Application (CANDA) is reviewed . This system consisted of a stand-alone personal computer running sev eral commercial programs in Microsoft Windows to access both text and data. WordPerfect was used as the word processor that contained all th e documents and data tables (in read-only format) that were submitted in hard copy, and Andyne GQL was used as a tool to query the data in a n Oracle relational database. Microsoft Excel was provided as a spread sheet for graphics and analysis of data. Documents appeared virtually identical to those in the hard copy NDA submission. Searching the text was facilitated by the use of buttons on the screen, which allowed th e NDA to be searched for a particular term. Data could be located eith er in WordPerfect documents, or in an Oracle database (using Andyne GQ L) by querying the data. The data queries could be performed ad hoc, i n which the reviewer selected all the parameters for a search, or with predefined query buttons, which retrieved data for principal treatmen t-related changes. This type of system also could serve as a useful mo del for both inhouse nonclinical review and the submission of INDs and IND amendments. (C) 1995 Academic Press Inc.