References
- Burns J. Metabolic considerations in implementing toxicity studies. Symposium at the National Meeting of the Academy of Pharmaceutical Sciences. 1978. Hollywood, Florida
- Case D. E., Lindup W. E., Lowery C., Orton T. C., Reeves P. R., Whittaker S. E. Proc. Br. Pharm. Soc. 1978; 352
- Compliance Program Guidance Manual October, 1981, Chapter 48—Human Drugs—Drugs—Bioresearch Monitoring, Food and Drug Administration (US Department of Commerce, National Technical Information Service).
- D.H.S.S. MAL-4: Notes on Applications for Clinical Trial Certificates. 1977, (Medicines for Human Use)
- D.H.S.S. MLX 130: Data Requirements for Clinical Trial Certificates, Annex A. 1981
- Di Carlo F. J. Drug Metab. Rev. 1979; 9(2)v
- Drug Research Board, National Academy of Sciences—National Research Council. Clin. Pharmac. Ther. 1969; 10: 607
- General Metabolism Studies. Federal Register 1978; Vol. 43, No. 163, 37394.
- Glocklin V. C. General considerations for the study of the metabolism of drugs and other chemicals. Federation of American Societies for Experimental Biology, Symposium on Drug Metabolism in the Design and Implementation of Pathology and Toxicology Studies. Atlanta, Georgia 1981
- Goldenthal E. I. Office of New Drugs, Bureau of Medicine. 1968, Letter to Industry dated 15 July 1968
- Guidelines for the Application of the Registration of Pharmaceutical Specialities. 1980, (Drug Department of the National Board of Health and Welfare, Sweden)
- Hile J. P. Letter quoted, with FDA permission, to member companies of the DMDG. 1979, see also ‘Remarks‘ Prepared for Delivery to the Quality Assurance Group (United Kingdom) Good Laboratory Practice, 1978, London, UK.
- Interagency Regulatory Liaison Group. Notice of IRLG work plans and public meetings. Federal Registervol. 43 No. 34. 1978, 7174
- Mitchell J. R. (Chairman). Guidelines for preclinical testing of drugs for hepatotoxicity. 1978, (Hepatotoxicity Subcommittee of the FDA), reported Scrip, July 1978, No. 316 and FDC Reports, June 1978.
- Notes for Guidance on Pharmacokinetics and Metabolic Studies in the Safety Evaluation of New Drugs in Animals 1979
- Commission of the European Communities. Organisation for Economic Cooperation and Development. OECD Guidelines for Testing of Chemicals. HMSO, London 1981, (in the press)
- Ritchie J. C., Sloan T. P., Idle J. R., Smith R. L. Environmental Chemicals, Enzyme Functions and Human Disease. Excerpta Medica, Amsterdam 1980; 219, Ciba Foundation Symposium 76
- Rotenberg K. S. IND/NDA Guidelines for Bioavailability Submission. 20th Annual International Industrial Pharmacy Conference, Austin, Texas. Smoking and Health, Report of the Surgeon General, US Department of Health Education and Welfare, Public Health Service, 1979. The Interactions of Smoking with Drugs, Food Constituents and Responses in Diagnostic Tests (chapter 12 of pre-publication issue). 1981
- Weiner M., Newberne J. W. Toxic appl. Pharmac. 1977; 41: 231
- WHO Study Group on the Potential Carcinogenicity of Nitrosatable Drugs. WHO Drug Information Bulletin. 1978, PDT/DI/78.2. referred to in