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Original Articles

Human safety data collection and evaluation for the approval of new animal drugs

Pages 837-857 | Received 07 Jul 1977, Accepted 28 Jul 1977, Published online: 20 Oct 2009

References

  • 1977 . Federal Register , February 22 : 10412
  • Friedman , L. 1970 . Symposium on the evaluation of the safety of food additives and chemical residues: II. The role of the laboratory animal study of intermediate duration for evaluation of safety . Toxicol. Appl. Pharmacol. , 16 : 498 – 506 .
  • Kolbye , A. C. Regulatory considerations concerning mutagenesis . Paper presented at the Annual Seminar of the Society of Cosmetic Chemists . May 5 , Montreal, Canada.
  • Nelson , N. Food and Drug Administration Advisory Committee on Protocols for Safety Evaluations: Panel on Reproduction . 1970 . Report on reproduction studies in the safety evaluation of food additives and pesticide residues . Toxicol. Appl. Pharmacol. , 16 : 264 – 296 .
  • Nelson , N. Food and Drug Administration Advisory Committee on Protocols for Safety Evaluation: Panel on Carcinogenesis . 1971 . Report on cancer testing in the safety evaluation of food additives and pesticides . Toxicol. Appl. Pharmacol. , 20 : 419 – 438 .

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