-
2
-
-
33748616514
-
DNA vaccines: safety aspect assessment and regulation
-
Medjitna TD, Stadler C, Bruckner L, Griot C, Ottiger HP. DNA vaccines: safety aspect assessment and regulation. Dev Biol. 2006;126:261-207.
-
(2006)
Dev Biol.
, vol.126
, pp. 261-207
-
-
Medjitna, T.D.1
Stadler, C.2
Bruckner, L.3
Griot, C.4
Ottiger, H.P.5
-
3
-
-
84885498805
-
-
ICH Safety Guidelines: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals. ICH S6 (1997); ICH S6(R1)
-
ICH Safety Guidelines: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals. ICH S6 (1997); ICH S6(R1) (2008). International Conference on Harmonization. Available at: www.ich.org.
-
(2008)
International Conference on Harmonization
-
-
-
4
-
-
34547656228
-
The application of discovery toxicology and pathology towards the design of safer pharmaceutical lead candidates
-
Kramer JA, Sagartz JE, Morris DL. The application of discovery toxicology and pathology towards the design of safer pharmaceutical lead candidates. Nat Rev/Drug Discov. 2007;6:636-648.
-
(2007)
Nat Rev/Drug Discov.
, vol.6
, pp. 636-648
-
-
Kramer, J.A.1
Sagartz, J.E.2
Morris, D.L.3
-
5
-
-
0033771951
-
Concordance of the toxicity of pharmaceuticals in humans and in animals
-
Olson H, Betton G, Robinson D, Thomas K, Monro A, Kolaja G. Concordance of the toxicity of pharmaceuticals in humans and in animals. Regul Toxicol Pharmacol. 2000;32:56-67.
-
(2000)
Regul Toxicol Pharmacol.
, vol.32
, pp. 56-67
-
-
Olson, H.1
Betton, G.2
Robinson, D.3
Thomas, K.4
Monro, A.5
Kolaja, G.6
-
6
-
-
1642282158
-
First dose of potential new medicines to humans: how animals help
-
Greaves P, Williams A, Eve M. First dose of potential new medicines to humans: how animals help. Nat Rev/Drug Discov. 2004;3:226-236.
-
(2004)
Nat Rev/Drug Discov.
, vol.3
, pp. 226-236
-
-
Greaves, P.1
Williams, A.2
Eve, M.3
-
7
-
-
84885565027
-
-
ICH Quality Guideline: Impurities in New Drug Products. ICH Q3B(R2). International Conference on Harmonization
-
ICH Quality Guideline: Impurities in New Drug Products. ICH Q3B(R2). International Conference on Harmonization; 2006. Available at: www.ich.org.
-
(2006)
-
-
-
8
-
-
77955349920
-
Guidance for Industry: Genotoxic And Carcinogenic Impurities in Drug Substances And Products: Recommended Approaches.
-
U.S. Department of Health and Human Services Food and Drug Administration
-
Guidance for Industry: Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches. U.S. Department of Health and Human Services, Food and Drug Administration; 2008.
-
(2008)
-
-
-
9
-
-
33748319204
-
Guidance for Industry: Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers
-
U.S. Department of Health And Human Services Food And Drug Administration and Center for Drug Evaluation and Research
-
Guidance for Industry: Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; 2005.
-
(2005)
-
-
-
10
-
-
53549097600
-
Guidance for Industry: Safety Testing of Drug Metabolites
-
U.S. Department of Health And Human Services Food And Drug Administration and Center for Drug Evaluation and Research
-
Guidance for Industry: Safety Testing of Drug Metabolites. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; 2008.
-
(2008)
-
-
-
11
-
-
0016685233
-
Methods for detecting carcinogens and mutagens with the Salmonella/mammalian-microsome mutagenicity test
-
Ames BN, McCann J, Yamasaki E. Methods for detecting carcinogens and mutagens with the Salmonella/mammalian-microsome mutagenicity test. Mutat Res. 1975;31:347-364.
-
(1975)
Mutat Res.
, vol.31
, pp. 347-364
-
-
Ames, B.N.1
McCann, J.2
Yamasaki, E.3
-
12
-
-
0020533372
-
Revised methods for the Salmonella mutagenicity test
-
Maron DM, Ames BN. Revised methods for the Salmonella mutagenicity test. Mutat Res. 1983;113:173-215.
-
(1983)
Mutat Res.
, vol.113
, pp. 173-215
-
-
Maron, D.M.1
Ames, B.N.2
-
13
-
-
84885552397
-
ICH Multidisciplinary Guideline: Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals
-
ICH M3. International Conference on Harmonization
-
ICH Multidisciplinary Guideline: Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals. ICH M3. International Conference on Harmonization; 1997. Available at: www.ich.org.
-
(1997)
-
-
-
14
-
-
84885552397
-
ICH Multidisciplinary Guideline: Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals
-
International Conference on Harmonization; ICH M3(R1)
-
ICH Multidisciplinary Guideline: Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals. International Conference on Harmonization; ICH M3(R1). 1997. Available at: www.ich.org.
-
(1997)
-
-
-
15
-
-
84885562101
-
ICH Multidisciplinary Guideline: Nonclinical Safety Studies for the Conduct of Human Clinical Trials And Marketing Authorization for Pharmaceuticals
-
ICH M3(R2). International Conference on Harmonization
-
ICH Multidisciplinary Guideline: Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. ICH M3(R2). International Conference on Harmonization; 2008. Available at: www.ich.org.
-
(2008)
-
-
-
16
-
-
84885510999
-
ICH Safety Guideline: Duration of Chronic Toxicity Testing in Animals (Rodent And Non-rodent Toxicity Testing)
-
ICH S4. International Conference on Harmonization
-
ICH Safety Guideline: Duration of Chronic Toxicity Testing in Animals (Rodent and Non-rodent Toxicity Testing). ICH S4. International Conference on Harmonization; 1999. Available at: www.ich.org.
-
(1999)
-
-
-
17
-
-
84885559242
-
ICH Safety Guideline: Detection of Toxicity to Reproduction for Medicinal Products And Toxicity to Male Fertility
-
ICH S5(R2). International Conference on Harmonization
-
ICH Safety Guideline: Detection of Toxicity to Reproduction for Medicinal Products and Toxicity to Male Fertility. ICH S5(R2). International Conference on Harmonization; 1994. Available at: www.ich.org.
-
(1994)
-
-
-
18
-
-
84885518297
-
ICH Safety Guideline: Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals
-
ICH S1A. International Conference on Harmonization
-
ICH Safety Guideline: Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals. ICH S1A. International Conference on Harmonization; 1996. Available at: www.ich.org.
-
(1996)
-
-
-
19
-
-
84885549634
-
ICH Safety Guideline: Testing for Carcinogenicity of Pharmaceuticals
-
ICH S1B. International Conference on Harmonization
-
ICH Safety Guideline: Testing for Carcinogenicity of Pharmaceuticals. ICH S1B. International Conference on Harmonization; 1998. Available at: www.ich.org.
-
(1998)
-
-
-
20
-
-
84885558329
-
ICH Safety Guideline: Guidance on Genotoxicity Testing And Data Interpretation for Pharmaceuticals Intended for Human Use
-
ICH S2(R1). International Conference on Harmonization
-
ICH Safety Guideline: Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use. ICH S2(R1). International Conference on Harmonization; 2008. Available at: www.ich.org.
-
(2008)
-
-
-
21
-
-
84885493769
-
ICH Safety Guideline: Immunotoxicity Studies for Human Pharmaceuticals
-
ICH S8. International Conference on Harmonization
-
ICH Safety Guideline: Immunotoxicity Studies for Human Pharmaceuticals. ICH S8. International Conference on Harmonization; 2006. Available at: www.ich.org.
-
(2006)
-
-
-
22
-
-
1842571737
-
Center for Food Safety And Applied Nutrition's Redbook
-
U.S. Food And Drug Administration
-
Center for Food Safety and Applied Nutrition's Redbook. U.S. Food and Drug Administration. Available at: www.cfsan.fda.gov/~redbook/red-ivb1.html.
-
-
-
-
24
-
-
14444267319
-
Regulatory considerations for preclinical development of anticancer drugs
-
DeGeorge JJ, et al. Regulatory considerations for preclinical development of anticancer drugs. Cancer Chemother Pharmacol. 1998;41:173-185.
-
(1998)
Cancer Chemother Pharmacol.
, vol.41
, pp. 173-185
-
-
DeGeorge, J.J.1
|