Resource Bibliography
Science and General
- Molecular Modification in Drug Design. Advances in Chemistry Series, 45. American Chemical Society, Washington, D. C. 1964
- Denkewaltar R. G., Tishler M. drug Research - Whence and Whither. Progress in Drug Research, E. Jucker. Birkhäuser, Basel 1966; 10: 11
- Cavallito C. J. Contributions of Medicinal Chemistry to Medicine -from 1935. “progress in Drug Research”, E. Jucker. Birkhäuser, Basel 1968; 12: 11
- Edwards C. C. Toward a New Understanding. Mad. Marketing & Media. Dec., 1970; 12
- Medicinal Chemistry. Parts I and II 3rd ed., A. Burger. Wiley-Interscience, New York
- de Stevens G. The Future of Drug Research. Med. Marketing & Media. April, 1971; 24
- Abrams W. B. Introducing a New Drug into Clinical Practice. Anesthesiology. 1971; 35: 176
- Drug Discovery - Science and Development in a Changing Society. Advances in Chemistry Series, 108. American Chemical Society, Washington, DC 1971
- The Development and Control of New Drug Products. Proceedings of 1971 Symposium, Vancouver, 1972, M. Pernarowski, M. Darrach. Evergreen Press
- Gordon A. J., Gilgoze S. G. The Art and Science of Contemporary Drug Development. “Progress in Drug Research”, E. Jucker. Birkhäuser, Basel 1972; 16: 194
- How Modern Medicines are Discovered, F. H. Clarke. Futura Publishing Co., Mt. Kisco, NY 1973
- Tishler M. Drug discovery - background and foreground. Clin. Pharmacol. Therap. 1973; 14: 479
- In Whose Hands. Economic Priorities Report, Council on Economic Priorities. New York, NY 1973
- DeFelice S. L. An Analysis of the Relationship between Human Experimentation and Drug Discovery in the U.S. Drug Metabolism Rev. 1974; 3: 167
Drug Product Quality & Equivalence
- Drug Product Quality. Acad. Pharm. Sci. Amer. Pharm. Assoc., Washington, DC 1969
- White Paper on the Therapeutic Equivalence of Chemically Equivalent Drugs. J. Am. Med. Assoc. 1969; 208: 1171
- Cavallito C. J. Therapeutic (?) Equivalence. N.A.R.D. Journal 1969; 91(2)29
- Edwards C. C. The F.D.A.'s Views on Generic Equivalence and Drug Quality. Pharmacy Times June, 1970; 46
- Wagner J. G. Biopharmaceutics and Relevant Pharmacokinetics. Drug Intelligence Publications, Hamilton, Ill. 1971
- Chodos D. J., DiSanto A. R. Basics of Bioavailability. The Upjohn Company, Kalamazoo, Mich. 1973
- Simmons H. E. Assuring Total Drug Quality. J. Am. Pharm. Assoc. 1973; NS13: 96
- Report of the Ad Hoc Committee on Drug Product Selection of the Acad. Gen. Practice Pharmacy and the Acad. Pharmaceut. Sciences, J. Am. Pharm. Assoc. 1973; NS13: 278
- The Muzzling of Max Feinberg. Private Practice. The Upjohn Company, Kalamazoo, Mich. May, 1974; 9
- Cavallito C. J. Why the Evaluation of Drug Product Quality is Not Static. Pharmacy Times Dec., 1974; 34, (Condensed from an N.P.C. Symposium
- Considerations in the Development of Drug Products Formularies. Acad. Pharm. Sci. Am. Pharm. Assoc., Washington, DC 1974
Drug Regulations and Impact
- Lasagna L. Research, Regulation, and Development of New Pharmaceuticals: Past, Present, and Future. Am. J. Med. Sci. 1972; 263(Pt.1)8
- Regulating New Drugs, R. L. Landau. Univ. Chicago Center for Policy Study, Chicago, Ill. 1973
- Wardell W. M. Clin. Pharmacol. and Therap., 14, 773, 1022 (1973); 15, 73 (1974). (Drug Lag, Therapeutic Implications, U.S. vs. U.K. Comparisons, etc); also J. Am. Med. Assoc. 1974; 229: 1457
- Edwards C. C. The Role of Government and F. & D.A. Regulations in Drug R. & D. Research Management 1974; 17: 21
- Hollister L. E. The F. & D.A. Ten Years After the Kefauver Harris Amendments. Perspectives in Biol, and Med. 1974; 18: 242
- de Haen P. Current Trends in the Introduction of New Drugs. Clin. Pharmacol. Therap. 1974; 16: 413
- Sarett L. H. F.D.A. Regulations and Their Influence on Future R. & D. Research Management 1974; 17: 18
- Development and Introduction of New Cardiovascular Drugs, (Symposium). Am. J. Cardiology 1974; 34: 457
Economics
- Economic Aspects of R. & D. Intensity in the Pharmaceutical Industry. Composite Profile of Six Major Companies. J. J. Friedman & Associates, Washington, DC 1973
- Peltzman S. An Evaluation of Consumer Protection Legislation: The 1962 Drug Amendments. J. Polit. Econ. 1973; 81: 1049
- Duetsch L. L. Research Performance in the Ethical Drug Industry. Marquette Business Review 1973; 17: 129
- Drug Development and Marketing: Aspects of Public Policy. Conference, Washington, DC, 1974. American Enterprise Institute for Public Policy Research
- New Drugs in Humans. Notice of Availability of Health Research Group Petition on Investigational Use. Federal Register 1974; 39: 13797
- Maximum Allowable Cost for Drugs. Federal Register 1974; 39: 40302
- Pharmaceutical Preparations, Except Biologicals. Current Industrial Reports. U.S. Dept. of Commerce, Bureau of the Census Industry Division, Washington, DC, Annually
Congressional Committees and Reports
- “Administered Prices, Drugs” Report of the Committee on the Judiciary, U.S. Senate, made by Subcommittee on Antitrust and Monopoly pursuant to S. Res. 52, 87th Congress, 1st session. June 27, 1961
- “Drug Industry Antitrust Act. Part 4, Pharmaceutical Manufacturers Association”. Hearings before the Subcommittee on Antitrust and Monopoly of the Committee on the Judiciary, U.S. Senate, 87th Congress, first session, pursuant to S. Res.52 on S.1552, Dec.7, 8 9 1961
- “Drug Literature” Report prepared for the Study of “Interagency Coordination in Drug Research and Regulation” by the Subcommittee on Reorganization and International Organizations of the Senate Committee on Government Operations. August 30, 1963
- “Interagency Coordination in Drug Research and Regulation”. “The Bureau of Medicine in the F. & D.A.” Hearings before the Subcommittee on Reorganization and International Organizations of the Committee on Government Operations., U.S. Senate, 88th Congress, first session, Part 3, March 20, 1963
- “Government Patent Policy” Hearings before the Subcommittee on Patents, Trademarks, and Copyrights of the Committee on the Judiciary U.S. Senate, 89th Congress, 1st session. Part 1, June 1,2,3, 1965; Part 2, July 6,7; August 17, 19, 1965
- “Part 4 - Dept. of H.E.W. Appropriations for 1967” Hearings before a Subcommittee of the Committee on Appropriations, House of Representatives, 89th Congress, 2nd session, 1966
- “The Administration of Research Grants in the Public Health Service” 9th Report by the Committee on Government Operations, House of Representatives, 1967
- Hearings before Subcommittee on Health, Committee on Labor and Public Welfare, U.S. Senate. Various Subjects from Dec.18, 1973 through December 5, 1974
- “Drug Bioequivalence”, A Report of the Office of Technology Assessment, Drug Bioequivalence Study Panel, 1974
- “Use of Advisory Committees by the Food and Drug Administration” Hearings before the Intergovernmental Relations Subcommittee of the Committee on Government Operations, House of Representatives, March 6,7,8, 12,13; April 30; May 21, 1974
- F.D.A.'s Freedom of Information Regs., Special Supplement, F-D-C-Reports 36, No.49 (1974). Federal Register 1974; 39: 44602–44657