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Research Article

FDA/GLP Regulations

Pages 59-145 | Published online: 28 Sep 2008

References

  • Federal Register 1976; 41: 51206
  • Federal Register 1978; 43: 59986, corrected Federal Register. 44: 17657 (1979)
  • Federal Register 1980; 45: 2486
  • Federal Register 1987; 52: 33768, corrected Federal Register. 52: 36863 (1987)
  • Federal Register 1989; 54: 9038
  • Federal Register 1989; 54: 15923
  • Federal Register 1991; 56: 32087
  • Good Laboratory Practice for Nonclinical Laboratory Studies, 21 C.F.R. Part 58
  • , 21 U.S.C. $ 371 (a)
  • Current Good Manufacturing Practice for Finished Pharmaceuticals, 21 C.F.R. Part 211
  • Food and Drug Administration. Good Laboratory Practice Regulations Management Briefings-Post Conference Report
  • Food and Drug Administration, Dockets Management Branch [HFA-305] (available under Freedom of Information)
  • Willig S. H., Tuckerman M. M., Hitchings W. S., IV. Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control 2nd Ed. Revised and Expanded, Marcel Dekker, Inc. 1982; 201
  • Willig S. H., Stoker J. R. Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control, 3rd Ed. Marcel Dekker, Inc. 1991; 187
  • 9 C.F.R. Subchapter A—Animal Welfare
  • Allen G. O., Hirsch A. F., Leidy H. Application of military STD 105D sampling plans to research report audits to meet GLP requirements. Drug Information Journal 1980; 14: 65
  • Siconolfi R. M. Statistical approaches to auditing. Managing Conduct and Data Quality of Toxicology Studies. Princeton Scientific Publishing Co., Inc. 1986; 223
  • U.S. Department of Defense, MIL-C-45662A. 9 February, 1962
  • Diamond S. Z. Preparing Administrative Manuals. AMACOM. 1981
  • Lepore P. Presentation at PRIMR's. The Animal Care Committee and Enforced Self-Regulation: Making it Work at Your institution conference, Boston, March, 19–201992
  • U. S. Department of Health and Human Services. Guide for the Care and Use of Laboratory Animals. 1985, NIH Publication No. 85–23

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