上海cmc培訓(xùn)美國仿制藥申報和當(dāng)前的挑戰(zhàn)從研發(fā)到注冊上市(已修改)
2025-10-26 08:32 本頁面
【正文】 Jim Huang, PhD 黃河 AAPS/CPA Workshop Shanghai, June 2829, 2021 Generic Drug Applications and Current Challenge: From Development to Market in the . 美國仿制藥申報和當(dāng)前的挑戰(zhàn) : 從研發(fā)到注冊上市 Table of Contents Product Selection Development Process ANDA filing Commercialization Table of Contents Product Selection Development Process ANDA filing Commercialization Building first class generics by...... .. balancing a strong portfolio .. offering the right products, reliable and fast .. developing or licensing technologies for DTR product .. having an aggressive approach to battling cost .. launching product on time from internal teamwork Selection Process Portfolio Development ? Brand Sale (IMS data) ? New Product Value (NPV) – projection ? Product Indication – petition ? Business case for approval IP Evaluation Technical Evaluation Commercial launch (base and best case) ? Key Patents (Orange book amp。 published) ? FTF (PIV) or FTM opportunity ? Exclusivity expiry/Pediatric exclusivity ? Formulation challenge (difficult to replicate) ? Analytical Issues (reversed engineering) ? Competitive intelligent ? Market formation (forecast) ? ANDA Approval (estimate) ? Launch (projection) B a l a n ce d P o r t f o l i oS O D I RS O D E RI n j ec ta b l eT o p i c a lO r a l l i q u i d? SOD IR ? Traditional ? Chewable ? ODT ? SOD ER ? Pellets ? Matrix/Coated ? Matrix/Barrier ? Osmotic ? Other technologies ? Injectable ? Fast acting ? Depo ? Topical ? w/clinical ? Corticosteroids ? Topical solutions ? Oral Liquid ? Liquid ? Suspension Strategy by balancing portfolio Product
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