5 Role of CE in drug substance and drug product development

Separation Science and Technology

Volumn 9, Issue , 2008, Pages 95-121

  Grosche, Oliver ^a   Zeitz, Markus ^b  

^a NOVARTIS PHARMA K K   (Japan)

^b NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Assay; Chiral purity; Cleaning verification; Clinical development; Dissociation constant determination; Distribution coefficient determination; Drug product; Drug substance; Functional excipients; High throughput analysis; Identification; In process control; Method transfer; Pharmaceutical salts; Preclinical development; Purity; Release analysis; Specification setting; Stability testing

Indexed keywords

EID: 47749122945     PISSN: 01496395     EISSN: None     Source Type: Book Series    
DOI: 10.1016/S0149-6395(07)00005-0     Document Type: Review

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