Computer-assisted New Drug Applications Research Articles

Canda Submissions: A Retrospective Look at a Sponsor’s Experience

Computer assisted new drug applications (CANDAs) can be as simple as data submitted in electronic format such as ASCII files, or as complex and sophisticated as systems that enable the Food and Drug Administration (FDA) reviewer to access sponsor databases, case report form (CRF) images, listings, tables, and text. A CANDA application was submitted to the Division of Topical Drug Products of FDA for Loprox® Gel by Hoechst-Roussel Pharmaceuticals Inc. (now Hoechst Marion Roussel, Inc.) in December 1994. The software used for this submission, Integrated CANDA™ (ICANDA), was a data access, review, and reporting tool that enabled the FDA reviewer to access the clinical database, the CRF images, tables, and report text. The reviewer could create tables, listings, graphs, perform simple statistical analyses, and cut and paste from the generated output to his review document. The features of the software, contents of the submission, corresponding documention, validation, and advantages and disadvantages of this CANDA submission are presented.

The Value of Candas in Drug Development

Faster time to action and facilitated review are the expected benefits when regulatory agencies use computer-assisted new drug applications (CANDAs). Although no statistics are available to support these benefits, CANDAs continue to be used widely. Sponsors began to use CANDAs in-house also, and the benefits in this area were unexpected. This research of 32 pharmaceutical sponsors showed that when CANDAs were used internally, a better quality new drug application (NDA) appears to result. Use of CANDAs by sponsors in preparing an NDA did not extend the time of submission preparation; nor did it appear to speed the process.

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 several commercial programs in Microsoft Windows to access both text and data. WordPerfect was used as the word processor that contained all the 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 an Oracle relational database. Microsoft Excel was provided as a spreadsheet 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 the NDA to be searched for a particular term. Data could be located either in WordPerfect documents, or in an Oracle database (using Andyne GQL) by querying the data. The data queries could be performed ad hoc, in which the reviewer selected all the parameters for a search, or with predefined query buttons, which retrieved data for principal treatment-related changes. This type of system also could serve as a useful model for both inhouse nonclinical review and the submission of INDs and IND amendments.

Integrated Clinical Databases: Developing an Effective Strategy toward a CANDA

The organization of a core data structure capable of accurately and efficiently reporting clinical submission data has been an often elusive objective for many clinical data managers. In addition, the arrival of computer assisted new drug applications (CANDAs) has reemphasized existing requirements and highlighted new integration problems. A single integrated clinical database (ICDB) is proposed as a solution and one proven integration methodology is presented which explains the complete process while detailing the most common problems encountered.

Lek's Approach to CAANDAs

To date, the pharmaceutical industry has focused primarily on document management and systems associated with electronic or computer assisted new drug applications (CANDAs). While generic drugs represent a large segment of the Food and Drug Administration's (FDA) work, not much has been reported about computer assisted abbreviated new drug applications (CAANDAs). For development of LEK's CAANDA system, standard hardware and software were primarily used, including a Windows environment on an IBM-PC platform. LEK's CAANDAs consist of three main components: control shell, file viewer, and text searcher. Criteria for choosing the appropriate software, choices made, and a brief description of their functions are included. The way in which the experimental system was implemented in practice and the initial results of the new way of working are also described. This system, being simple and inexpensive, can be used for preparing registration documentation for various drugs and formulations for any country's regis...

What is the Future of the Canda at FDA?

The industry and the Food and Drug Administration (FDA) are working together to ease the transition of new drug applications (NDAs) into computer-assisted NDAs (CANDAs). To insure that CANDAs are reviewable one must have a solid understanding of the regulatory review process and the ways in which automation can enhance that process. This paper presents the Center for Drug Evaluation and Research’s (CDER) efforts to prepare for a future of electronic submissions.

CANDA Overview: What Should a CANDA Look Like?

The move toward electronic submission and review of new drug applications (NDAs) is expected to make the drug development process more efficient both for drug spon­ sors and the Food and Drug Administration (FDA). Electronic tools have been devel­ oped for text management, image management, and data manipulation, increasing the efficiency of FDA review and enabling pharmaceutical companies to bring new drugs to market quicker. This paper focuses on tools used to access, retrieve, and display information in the NDA submission, concentrating mainly on the text and image portions. It will conclude with a description of an "ideal" computer-assisted new drug application (CANDA) system and how it could be used by both the drug sponsor and the regulatory reviewer.

The Progression and Integration of the Statistical Canda at Merck

Merck has submitted its second generation statistical computer assisted new drug application (CANDA) to the Food and Drug Administration (FDA). Continued development at Merck of the CANDA focused on the implementation of advanced features, analysis and implementation of a new hardware platform, and the initial incorporation of the CANDA as an internal new drug application (NDA) development tool.

Computers in the new drug application process.

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.