SCOPUS 정보 검색 플랫폼

Advanced Drug Delivery Reviews

Volumn 59, Issue 1, 2007, Pages 38-42

Toxicological overview of impurities in pharmaceutical products

(2) Jacobson Kram, David a McGovern, Timothy b

a CENTER FOR DRUG EVALUATION AND RESEARCH (United States)

b CENTER FOR DRUG EVALUATION AND RESEARCH (United States)

Author keywords

European Medicines Agency (EMEA); Genotoxic impurities; Pharmaceutical impurities; Toxicology

Indexed keywords

DRUG SUBSTANCES; GENOTOXIC IMPURITIES; PHARMACEUTICAL IMPURITIES;

DRUG PRODUCTS; REGULATORY COMPLIANCE; RISK ASSESSMENT; TOXICITY;

IMPURITIES;

1,1,1 TRICHLOROETHANE; 1,2 DICHLOROETHANE; AMINOACRIDINE; BENZENE; CARBON TETRACHLORIDE; MESYLIC ACID;

AMES TEST; CARCINOGENICITY; CHROMOSOME DAMAGE; DRUG IMPURITY; DRUG QUALITY; DRUG RESEARCH; DRUG SAFETY; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; GENE MUTATION; GENOTOXICITY; MUTAGENICITY; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT; UNITED STATES;

DRUG CONTAMINATION; EUROPE; GUIDELINES AS TOPIC; HUMANS; INTERNATIONAL COOPERATION; MUTAGENS; PHARMACEUTICAL PREPARATIONS; RISK ASSESSMENT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 33846833901 PISSN: 0169409X EISSN: None Source Type: Journal
DOI: 10.1016/j.addr.2006.10.007 Document Type: Review

Times cited : (117)

References (7)

1
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- ICH Q3 Q3A(R): impurities in new drug substances (revised guideline)
- ICH Q3 Q3A(R): impurities in new drug substances (revised guideline). Federal Register 68 68 (2003) 6924-6925
- (2003) Federal Register , vol.68 , Issue.68 , pp. 6924-6925

2
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- Q3B(R): impurities in new drug products (revised guideline)
- Q3B(R): impurities in new drug products (revised guideline). Federal Register 68 220 (2003) 64628-64629
- (2003) Federal Register , vol.68 , Issue.220 , pp. 64628-64629

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- Q3C: impurities: guideline for residual solvents
- Q3C: impurities: guideline for residual solvents. Federal Register 68 219 (2003) 64352-64353
- (2003) Federal Register , vol.68 , Issue.219 , pp. 64352-64353

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- European Medicines Evaluation Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on the limits of genotoxic impurities. CPMP/SWP/5199/02 (June 28, 2006) London
- (2006) Committee for Medicinal Products for Human Use (CHMP). Guideline on the limits of genotoxic impurities. CPMP/SWP/5199/02
- European Medicines Evaluation Agency¹

5
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- U.S. Food and Drug Administration (FDA), food additives: threshold of regulation for substances used in food-contact articles (final rule)
- U.S. Food and Drug Administration (FDA), food additives: threshold of regulation for substances used in food-contact articles (final rule). Federal Register 60 (1995) 36582-36596
- (1995) Federal Register , vol.60 , pp. 36582-36596

6
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- A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity
- Müller L., Mauthe R.J., Riley C.M., Andino M.M., De Antonis D., Beels C., DeGeorge J., De Knaep A.G.M., Ellison D., Fagerland J.A., et al. A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity. Regul. Toxicol. and Pharmacol. 44 (2006) 198-211
- (2006) Regul. Toxicol. and Pharmacol. , vol.44 , pp. 198-211
- Müller, L.¹ Mauthe, R.J.² Riley, C.M.³ Andino, M.M.⁴ De Antonis, D.⁵ Beels, C.⁶ DeGeorge, J.⁷ De Knaep, A.G.M.⁸ Ellison, D.⁹ Fagerland, J.A.¹⁰

7
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- Risk assessment of peak exposure to genotoxic carcinogens: a pragmatic approach
- Bos P.M.J., Baars B., Marcel T.M., and van Raaij M.T.M. Risk assessment of peak exposure to genotoxic carcinogens: a pragmatic approach. Toxicology Letters 151 (2004) 43-50
- (2004) Toxicology Letters , vol.151 , pp. 43-50
- Bos, P.M.J.¹ Baars, B.² Marcel, T.M.³ van Raaij, M.T.M.⁴

* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.