Abstract
There are several recent thoughtful and highly instructive publications on drug research that treat extensively the problems associated with the design and discovery of new chemical entities (e.g., [1–4]). In addition, the rate of new drug discovery and the economics of research and development have been under close scrutiny, particularly since enactment of the 1962 amendments to the Food, Drug, and Cosmetic Act of 1938 in the United States [4–7]. Quite apart from the actual drug-discovery efforts of a pharmaceutical manufacturer are the equally difficult, vitally important, and costly activities involved in the developmental stages that lead to an approved, marketable product. Very little has been published on the details of this broad and complex subject.
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References
R. G. Denkewalter and M. Tishler, Prog. Drug Res. 10, 11 (1966).
E. J. Ariens, Prog. Drug Res. 10, 429 (1966).
G. de Stevens, Medical Marketing and Media, April, p. 24 (1971).
J. E. Schnee, Research and Technological Change in the Ethical Pharmaceutical Industry, Ph.D. Dissertation, University of Pennsylvania (1969).
B. Bloom, The Rate of Contemporary Drug Discovery, presented at The Science of Drug Discovery, symposium (Div. of Med. Chem., ACS, Chicago, 15 September 1970) and published in: Lex et Scientia 8, No. 1, January–March (1971).
I. C. Winter, J. New Drugs, November-December, p. 306 (1964).
R. Slack and A. W. Nineham, Medical and Veterinary Chemicals, Vol. 1, The Nature of the Pharmaceutical Industry, chap. 1, and The Genesis of a New Drug, chap. 2 (Pergamon Press, London, and Elmsford, N.Y., 1968).
C. Anello, FDA Principals on Clinical Investigations, FDA Papers, June, p. 14 (1970).
S. G. Gilgore, Statement before House Subcommittee on Public Health and Welfare, Committee on Interstate and Foreign Commerce, 19 September 1969. (See Congressional Record, 19 September 1969.)
De Haen Non-Proprietary Name Index, Vol. 8 (Paul de Haen, Inc., New York 1971).
A. Tofler, Future Shock (Bantam Books, New York 1970), p. 27–30.
S. G. Gilgore, Researching a New Drug in Man, Drug Cosmet. Ind. 104, 4–2 (1969) and Med. Market. Media, May, p. 15 (1969).
J. T. Litchfield, J. Am. Med. Ass. 177, 104 (1961).
C. Djerassi, Science 169, 941 (1970).
W. D’Aguanno, FDC Law Journal, December, p. 539 (1970).
Drug Efficacy Study. A Report to the Commissioner of Food and Drugs (National Academy of Sciences, Washington, D.C., 1969).
A review of the Study’s history and its meaning has been published by C. E. Edwards, Am. Med. News, 31 May, p. 6 (1971).
W. J. Gyarfas and A. Welch, The IND Procedure: Assuring Safe and Effective Drugs, FDA Papers, September, p. 27–31 (1969).
Guidelines: Manufacturing and Controls for IND’s and NDA’s, FDA Papers, June, p. 4–14 (1971).
J. Jennings, Evaluation of the Efficacy of Drugs, delivered at the Annual Meeting and Conference of the National Association of Pharmaceutical Manufacturers, Downington, Pa., 20 June (1971).
S. Gilgore, Bull. Atom. Scient., June, p. 12 (1969).
Most often, at this stage a drug will be identified by a code number. In order to choose a good, non-proprietary name, the FDA recommends that a sponsor seek assistance from the Council of the USAN (US Adopted Names). The USAN is composed of three sponsors: the AMA, USP Convention, and APA (American Pharmaceutical Association). It publishes an annual compilation of trade names, available from USP Convention, Inc., 46 Park Ave., New York, N.Y. 10016.
Although new drug applications are reviewed by FDA personnel only, other aspects of regulatory affairs involve the use of non-FDA consultants. See J. D. Cooper, Ed., The Quality of Advice (Interdisciplinary Communication Associates, Inc., Wash., D.C., 1971), see [32].
Available as Stock No. 1712–0126 from Superintendent of Documents, US Government Printing Office, Washington, D.C., 20402. Price: 40 cents. The document is often amended.
For details, see Biological Products. Regulations. Title 42, Part 73, Division of Biologies Standards, NIH, Bethesda, Md. 20014.
The Code of Federal Regulations (CFR) codifies the general and permanent rules published in the Federal Register by Executive departments and agencies of the Federal Government. The Code is divided into 50 titles representing areas under Federal regulation; each title is divided into chapters usually bearing the name of the issuing agency. Each chapter is further subdivided into parts covering specific regulatory areas. Individual volumes of CFR are revised as of 1 January of each year. The CFR and the Federal Register are published by the Office of the Federal Register, National Archives and Records Service, GSA, as a special edition of the Federal Register. Both are available from US Government Printing Office, Washington, D.C. 20204. A subscription to the Federal Register is $25 per year.
Available at $5.50 per year ($6.75 for foreign mailing) from Government Printing Office, Washington, D.C. 20204.
Available from FDC Reports, Inc. ($180 per year) and Drug Research Reports, Inc. ($200 per year), 1152 National Press Building, Washington, D.C. 20004.
Published by Commerce Clearing House, 420 Lexington Av., New York N.Y. 10017, as part of a broader series, Topical Law Reports. The volumes on FDC matters are entitled Federal, All States, Drugs and Cosmetics, Food.
PMA, 1155 15th St., N.W., Washington, D.C. 20005.
Located at 1750 Pennsylvania Ave., Washington, D.C. (202–333–2230).
Interdisciplinary Communications Associates, Inc. (ICA), 1353 28th St., N. W., Washington, D.C. 20007, The first Conference proceedings, Decision-Making on the Efficacy and Safety of Drugs, has been published as Vol. 1 by ICA (1971). The second volume is also available [23].
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Gordon, A.J., Gilgore, S.G. (1972). The Art and Science of Contemporary Drug Development. In: Jucker, E. (eds) Progress in Drug Research / Fortschritte der Arzneimittelforschung / Progrès des recherches pharmaceutiques. Progress in Drug Research / Fortschritte der Arzneimittelforschung / Progrès des recherches pharmaceutiques, vol 16. Birkhäuser Basel. https://doi.org/10.1007/978-3-0348-7081-8_4
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