Regulatory strategies for the development of adjunctive cancer chemotherapies

Drug Information Journal

Volumn 31, Issue 3, 1997, Pages 789-803

  Hansen, Suzanne K ^a   Miller, Loren L ^b  

^a Trilex Pharmaceuticals Inc   (United States)

^b PPD   (United States)

Author keywords

Adjunctive; Cancer; Development; Regulatory strategy

Indexed keywords

ANTINEOPLASTIC AGENT;

ARTICLE; CANCER ADJUVANT THERAPY; DRUG APPROVAL; DRUG DEVELOPMENT; DRUG RESEARCH; METHODOLOGY; PLANNING; PRIORITY JOURNAL;

EID: 0030743177     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159703100320     Document Type: Article

References (7)

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2. O'Shaughnessy JA, Wittes RE, Burke G, Friedman MA, Johnson JR, Niederhuber JE, Rothenberg ML, Woodcock J, Chabner BA, Temple R. Commentary Concerning Demonstration of Safety and Efficacy of Investigational Anticancer Agents in Clinical Trials. J Clin Oncology. 1991;9(12):2225-2232.
3. Oncologic Drugs Advisory Committee Minutes. July 18, 1986. Comments by FDA on "Requirements for Data on Survival for Approval of Cancer Drug NDAs."
4. Mathieu M. New Drug Development: A Regulatory Overview. Waltham, MA: Paraxel International Corp.; 1994:272.
5. Miller LL, Edgar PP, Lackey V, Dalton M, Knight D. Regulatory Strategy: A Blueprint for Drug Development. Drug Inf J. 1994;28:325-330.
6. Madder BF. Tutorial Session on the Approval of Biologics. Presented at the Drug Information Association 30th Annual Meeting, June 5, 1994.
7. Cavagnaro J. Experience Relevant to the Demonstration of Product Safety and Activity of Monoclonal Antibodies: Current Guidance on Animal Testing. Rockville, MD: Food and Drug Administration; January 9, 1992.