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Published byChloe Tate Modified over 9 years ago
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Prequalification project Drs. Jan Welink
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http://apps.who.int/prequal/ * Note to applicants on the choice of comparator products for the prequalification project * Guideline on generics - Annex 7 (Multisource (generic) pharm. products: guidelines on registration requirements to establish interchangeability) - Annex 11 (Guidance on the selection of comparator pharm. products for equivalence assessment of interchangeable multisource (generic) products)
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ReferenceTest Pharmaceutical Equivalent Products Possible Differences Drug particle size,.. Excipients Manufacturing process Equipment Site of manufacture Batch size …. Documented Bioequivalence = Therapeutic Equivalence (Note: Generally, same dissolution specifications)
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acceptance criteria: comparative rate and extent of absorption pharmaceutical equivalence method: in principle comparative pharmacokinetics (AUC, C max ) 90% CI 80 - 125%
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CPH
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Bulgaria Romania
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application - national - MRP - DC - centralised
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application WHO submission of a complete dossier - bio-study - biowaiver approval of RSA RMS = applicant
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Approval of RSA submission application comparatoroutdated?? dossier other concerns well established use!!
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Thank you for your attention
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