Transcription of STABILITY TESTING Photostability - IAGIM
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STABILITY TESTING Photostability - IAGIM
International Journal of Generic DrugsInternational Journal273of Generic DrugsISSN 0793 694X US/Canada ISSN 0793 7784 EuroISSN 0793 7822 Pacific RimSTABILITY TESTINGP hotostabilityin New Drug Products ..evaluating Photostability is foremost for new chemical entities only - notin generic drugs, provided the container-closure protection is the 'INTRODUCTIONn June 1998 the FDA issued forcomment, a lengthy 110 page draftguidance titled ' STABILITY TESTING ofDrug Substance and DrugProducts' The STABILITY guidanceinterweaves the requirements of NDAsand ANDAs for both drug substanceand drug product and borrows heavilyfrom the European Guidelinesdo not readily affectGeneric DevelopmentThe New Draft Guidance to industry isextremely comprehensive and isintended to replace the ageing 1987guidelines, thus harmonising therequirements for US.
International Journal of Generic Drugs International Journal 273 of Generic Drugs ISSN 0793 694X US/Canada ISSN 0793 7784 Euro ISSN 0793 7822 Pacific Rim
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