1.5. Regulatory aspects: ICH and pharmacopoeial perspectives

Progress in Pharmaceutical and Biomedical Analysis

Volumn 4, Issue C, 2000, Pages 48-66

  Boehlert, Judy P ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

EID: 67349148816     PISSN: 14643456     EISSN: None     Source Type: Book Series    
DOI: 10.1016/S1464-3456(00)80007-1     Document Type: Article

References (27)

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4. ICH Guideline: Impurities in New Drug Substances. Federal Register 61 (January 4, 1996) 371ff
5. ICH Guideline: Impurities in New Drug Products. CPMP/ICH/282/95 (December 1996)
6. ICH Guideline: Impurities in New Drug Products. PAB/PCD Notification No. 539 (June 1997)
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8. Boehlert J.P. Pharm. Technol. 21 (1997) 56ff
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17. ICH Guideline: Residual Solvents. Federal Register 62 No. 247 (December 24, 1997) 67377ff
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22. The United States Pharmacopoeia 24 (2000), USP Convention, Inc., Rockville 2049
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27. Pharmeuropa Supplement 9 No. 1 (April 1997)