Q11 Development of APIs Training Introduction - TRIPHASE Pharma ...
Q11 Development of APIs Training Introduction - TRIPHASE Pharma ...
Q11 Development of APIs Training Introduction - TRIPHASE Pharma ...
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ICH <strong>Q11</strong> – <strong>Development</strong> & Manufacture <strong>of</strong>Drug SubstancesManufacturing Process <strong>Development</strong>• What data/information to submit ?o Summary overviewo Level <strong>of</strong> detail – pivotal v non-pivotal studieso Relevance <strong>of</strong> development studies to the commercialprocesso Effect <strong>of</strong> scaleo History <strong>of</strong> batches produced to date & linked to significantdevelopments in the manufacturing processo An applicant may adopt either a traditional or enhancedapproach to development <strong>of</strong> the process or a combination<strong>of</strong> both© 2011 ICH 10
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