Critical Assessment of Pharmaceutical ProcessesA Rationale for Changing the Synthetic Route

The focus of this review is to identify and characterize criteria for rejecting a synthetic route and thus trigger the search for a viable alternative. Given the current pressures on the pharmaceutical industry, process chemists are facing increasingly tough economic and regulatory hurdles and have...

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Bibliographic Details
Published inChemical reviews Vol. 106; no. 7; pp. 3002 - 3027
Main Authors Butters, Mike, Catterick, David, Craig, Andrew, Curzons, Alan, Dale, David, Gillmore, Adam, Green, Stuart P, Marziano, Ivan, Sherlock, Jon-Paul, White, Wesley
Format Journal Article
LanguageEnglish
Published United States American Chemical Society 01.07.2006
Subjects
Chemical synthesis
Chemistry
Chemistry, Pharmaceutical - legislation & jurisprudence
Chemistry, Pharmaceutical - methods
Chemistry, Pharmaceutical - standards
Drug-Related Side Effects and Adverse Reactions
Legislation, Drug
Pharmaceutical industry
Pharmaceutical Preparations - chemical synthesis
Pharmaceutical Preparations - chemistry
Pharmacology
Process engineering
Safety
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Summary:The focus of this review is to identify and characterize criteria for rejecting a synthetic route and thus trigger the search for a viable alternative. Given the current pressures on the pharmaceutical industry, process chemists are facing increasingly tough economic and regulatory hurdles and have less time with which to develop the commercial process for a drug candidate.
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SourceType-Scholarly Journals-1
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ObjectType-Review-1
ISSN:0009-2665
1520-6890
DOI:10.1021/cr050982w