Transcription of Addressing specific regulatory excipient …
{{id}} {{{paragraph}}}
Example: marketing
Addressing specific regulatory excipient …
Addressing specific regulatory excipientrequirements in the marketing authorizationAddressing specific regulatory excipientrequirements in the marketing authorizationDr. Philipp HebestreitGlobal regulatory AffairsPharma ingredients & ServicesBASF SEPharmSciFair Nice, June 11th, 2009Dr. Philipp Hebestreit, Pharma ingredients & Services, BASF SEPresentation PharmSciFair of excipient vs. API registrationzClassification of excipientszExcipient guidancezRegistration challenges of well-known vs. new excipientszThe basis for successful registration: excipient master fileszSafety assessment of excipientszHot topicszIndustry concernszCase study: Registration of a novel excipientzSummary & conclusionDr.
Dr. Philipp Hebestreit, Pharma Ingredients & Services, BASF SE Presentation PharmSciFair 11.06.2009 How are Excipients "approved"? zCross-references to pharma/ food/ cosmetic compendiae
Loading..
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: