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1
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0010316834
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Impurities in new drug products
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P.F. d'Arcy, & D.W.G. Harron. Belfast, UK: Greyston Books Ltd
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Boehlert J.P. Impurities in new drug products. d'Arcy P.F., Harron D.W.G. Proceeding of the Third International Conference on Harmonisation, Yokohama, 1995. 1996;86-90 Greyston Books Ltd, Belfast, UK.
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(1996)
Proceeding of the Third International Conference on Harmonisation, Yokohama, 1995
, pp. 86-90
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Boehlert, J.P.1
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2
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0001619236
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A regulatory perspective of the guidance on the utility of the two rodent species
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P.F. d'Arcy, & D.W.G. Harron. Belfast, UK: Greyston Books Ltd
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De George J.J. A regulatory perspective of the guidance on the utility of the two rodent species. d'Arcy P.F., Harron D.W.G. Proceeding of the Third International Conference on Harmonisation, Yokohama, 1995. 1996;274-277 Greyston Books Ltd, Belfast, UK.
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(1996)
Proceeding of the Third International Conference on Harmonisation, Yokohama, 1995
, pp. 274-277
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De George, J.J.1
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3
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0010365622
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International Conference on Harmonization S4 ICH guidelines can be obtained on internet at the following address:
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International Conference on Harmonization S4 (1991) Single dose and repeat dose toxicity tests. ICH guidelines can be obtained on internet at the following address: http://www.fda.gov/cder/guidance/index.htm.
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(1991)
Single Dose and Repeat Dose Toxicity Tests
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4
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0010316837
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International Conference on Harmonization S5A ICH guidelines can be obtained on internet at the following address:
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International Conference on Harmonization S5A (1993) Detection of toxicity to reproduction for medicinal products. ICH guidelines can be obtained on internet at the following address: http://www.fda.gov/cder/guidance/index.htm.
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(1993)
Detection of Toxicity to Reproduction for Medicinal Products
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5
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0010364274
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International Conference on Harmonization S5B ICH guidelines can be obtained on internet at the following address:
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International Conference on Harmonization S5B (1995) Reproductive toxicology: Male fertility study. ICH guidelines can be obtained on internet at the following address: http://www.fda.gov/cder/guidance/index.htm.
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(1995)
Reproductive Toxicology: Male Fertility Study
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6
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0010317012
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Repporteurs report on the ICH guideline
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P.F. d'Arcy, & D.W.G. Harron. Belfast, UK: Greyston Books Ltd
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Muller L. Repporteurs report on the ICH guideline. d'Arcy P.F., Harron D.W.G. Proceeding of the Third International Conference on Harmonisation, Yokohama, 1995. 1996;315-321 Greyston Books Ltd, Belfast, UK.
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(1996)
Proceeding of the Third International Conference on Harmonisation, Yokohama, 1995
, pp. 315-321
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Muller, L.1
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7
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0010364275
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Timing of non-clinical safety study in relation to clinical trials: Progress of the ICH guidelines
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P.F. d'Arcy, & D.W.G. Harron. Belfast, UK: Greyston Books Ltd
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Mayahara H. Timing of non-clinical safety study in relation to clinical trials Progress of the ICH guidelines . d'Arcy P.F., Harron D.W.G. Proceeding of the Third International Conference on Harmonisation, Yokohama, 1995. 1996;304-309 Greyston Books Ltd, Belfast, UK.
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(1996)
Proceeding of the Third International Conference on Harmonisation, Yokohama, 1995
, pp. 304-309
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Mayahara, H.1
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8
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0010360474
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Note for Guidance III/3979/88 Committee for Proprietary Medicinal Products (CPMP).
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Note for Guidance III/3979/88 (1990) Non-clinical tolerance testing of medicinal products. Committee for Proprietary Medicinal Products (CPMP).
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(1990)
Non-clinical Tolerance Testing of Medicinal Products
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9
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0010317427
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Guideline on genotoxicity testing: Impact and implementation of the ICH guidelines
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P.F. d'Arcy, & D.W.G. Harron. Belfast, UK: Greyston Books Ltd
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Tweats D. Guideline on genotoxicity testing Impact and implementation of the ICH guidelines . d'Arcy P.F., Harron D.W.G. Proceeding of the third International Conference on Harmonisation, Yokohama, 1995. 1996;307-311 Greyston Books Ltd, Belfast, UK.
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(1996)
Proceeding of the Third International Conference on Harmonisation, Yokohama, 1995
, pp. 307-311
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Tweats, D.1
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10
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0010318374
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International Conference on Harmonization S1B ICH guidelines can be obtained on internet at the following address:
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International Conference on Harmonization S1B (1995) Testing for Carcinogenicity of pharmaceuticals. ICH guidelines can be obtained on internet at the following address: http://www.fda.gov/cder/guidance/index.htm.
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(1995)
Testing for Carcinogenicity of Pharmaceuticals
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