Abstract
The clinical evaluation of a new chemical entity as a therapeutic agent, and its registration for use as a new drug, are very complex procedures. More than 10 years of research and approximately $65 million may be required from the time of original identification or synthesis of a compound to its commercial introduction as a marketed drug. The majority of the time and money are usually spent on clinical development.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
Similar content being viewed by others
References
Anello, C. (1974) Considerations of Significance—Clinical and Statistical, in Principles and Techniques of Human Research and Therapeutics vol. IV ( McMahon, F. G., ed.) Futura, Mt. Kisco, New York.
Bakke, O. M., Wardell, W. M., and Lasagna, L. (1984) Drug discontinuations in the United Kingdom and the United States, 1964 to 1983; Issue of safety. Clin. Pharmacol. Ther. 35 (5), 559–567.
Berglin. P. (1985) Personal communication.
Bezold, C. (1981) The Future of Pharmaceuticals Wiley, New York.
Cato, A. E. and Cook, L. (1984) The Protocol and Case Report Form, in The Clinical Research Process in the Pharmaceutical Industry ( Matorem, C. M., ed.) Marcel Dekker, New York.
Code of Federal Regulations (1977) 21 (52) Proposed in Federal Register, pp. 49612–49630.
Code of Federal Regulations (1981) 21 (56).
Federal Register (1981) 46 (17). p. 8950.
Federal Register (1985) 50 (36), New Drug and Antibiotic Regulations.
Finkel, M.J. (1984) Role of the FDA in the Clinical Research Process, in The Clinical Research Process in the Pharmaceutical Industry ( Matoren, G. M., ed.) Marcel Dekker, New York.
Friedman, L. M., Feinberg, C. D., and DeMets, D. L. (1984) Fundamentals of Clinical Trials, John Wright PSG, Littleton, Massachusetts.
General Considerations for the Clinical Evaluation of Drugs (1978) US Dept. of Health, Education and Welfare, Public Health Service, Food and Drug Administration.
Haegerstram, G., Huitfeldt, B.S. Nilsson, Sjovall, J., Syvalahti, E., and Whalen, A. (1982) Placebo in Clinical Drug Trials-a Multi- disciplinary Review, Meth. Find. Exp. Clin. Pharmacol 4 (4), 261–278.
Hodges, R. (1974) Ethical Considerations in Clinical Research, Techniques of Human Research and Therapeutics vol. 1 ( McMahon, F. G., ed.) Futura Publishing, Mt. Kisco, New York.
Holie, P. G. (1983) Johnson & Johnson: New Woe, NY Times.
Idanpaan-Heikkila, J. (1983) A Review of Safety Information Obtained from Phases I-II and Phase III Clinical Investigations of Sixteen Selected Drugs. US Dept of Health, Education and Welfare, Public Health Service, Food and Drug Administration.
Inman, W. H. H. (1981) Post-Marketing Drug Surveillance, in Risk-Benefit Analysis in Drug Research ( Cavalla, J. F., ed.) MTP, Lancaster, England.
Legrain, M. (1983) New Drug Superiority, in Decision Making in Drug Research (Gross, F., ed.) Raven, New York.
Matoren, G. M., ed. (1984) The Clinical Research Process in the Pharmaceutical Industry Marcel Dekker, New York.
McGee, D. and Gordon, T. (1976) in The Framingham Study: an Epidemiological Investigation of Cardiovascular Disease Publication No. (NIH) 76 - 1083, US Dept. of Health, Education, and Welfare, Washington, DC.
New Drug and Antibiotic Regulations (1985) in Federal Register 50 (36), pp. 7452–7519, Proposed rules will change the name of the IND to “Investigational New Drug Application.”
Public Law (1962) No. 87-781 (76 Stat. 780).
Schor, S. (1974) Relevant Considerations to the Statistical Analysis of Clinical Data, in Principles and Techniques of Human Research and Therapeutics vol. IV ( McMahon, F. G., ed.) Futura, Mt. Kisco, New York.
Shapiro, M. F. and Charrow. R. P. (1985) Special report: Scientific misconduct in investigational drug trials. N. Eng. J. Med. 312 (11), 731–736.
Sheck, L., Cox, C., Davis, H.T., Trimble, A. G., Wardell, W. M., and Hansen, R. (1984) Success rates in the United States drug development systems. Clin. Pharmacol. Ther. 36 (5), 574–583.
Sher, S. P., Bokelman, D. L., and Ditzler, W. D. (1980) Preclinical toxicity requirements for human drugs. Drug Inforn. J. April/June, 82–97.
Smithells, R. W. (1962) Thalidomide and malformations in Liverpool. Lancet i, 1270–1273.
Spilker, B. (1984) Guide to Clinical Studies and Developing Protocols, Raven, New York.
Sommerville, J. M., McLaren, E. H., Campbell, L. M., and Watson,J. M. (1982) Severe headache and disturbed liver function during treatment with zimelidine. Brit. Med. J. 285, 1009.
Stellar, S„ Ahrens, S. P., Meibohm, A. R., and Reines, S. A. (1984) Migraine prevention with timolol. J. Am. Med. Assoc. 252 (18), 2576–2580.
Tillman, C. R. and Koltz, B. E. (1981) Update on hepatotoxic drugs. Hospital Formulary 16, 847–852.
World Medical Assembly (1964) 18th, Helsinki, Finland, as revised by the 29th World Medical Assembly, Tokyo, Japan, 1975.
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 1987 The Humana Press Inc.
About this chapter
Cite this chapter
Reines, S.A., Fong, D. (1987). Clinical Evaluation of Drug Candidates. In: Williams, M., Malick, J.B. (eds) Drug Discovery and Development. Humana Press. https://doi.org/10.1007/978-1-4612-4828-6_12
Download citation
DOI: https://doi.org/10.1007/978-1-4612-4828-6_12
Publisher Name: Humana Press
Print ISBN: 978-1-4612-9180-0
Online ISBN: 978-1-4612-4828-6
eBook Packages: Springer Book Archive