OPS/OC/ONDQA/OGD - NIHS

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$Allergies to cross-reactive plant proteins. Latex-fruit ... - NIHS$

QbD to an FDA Generic Drug Reviewer • Defining target product quality profile – The performance needed to get clinical benefit and meet consumer expectation • Designing product and processes to meet target product quality profile • Identifying critical material attributes, process parameters, and sources of variability – Design space • Controlling materials and manufacturing processes to produce consistent quality over time 9
Target Product Quality Profile: Beginning the Drug Development with the End in Mind • FDA’s recent guidance on Target Product Profile (TPP) • The Target Product Quality Profile (TPQP) is a quantitative surrogate for aspects of clinical safety and efficacy that can be used to design and optimize a formulation and manufacturing process • ISPE PQLI: Pharmaceutical Target Product Profile • TPQP: Example – Assay (uniformity) – Purity – Stability – Desired pharmacokinetic profile • In vitro dissolution • Bioequivalence 10
Page 1 and 2: 添付資料 3 FDA visit agenda
Page 3 and 4: 添付資料 4-a FDA 後発医
Page 23 and 24: 添付資料 4-b FDA 後発医
Page 31 and 32: QbR is a System Generic Drug Applic
Page 33 and 34: Janet Woodcock on QbD J. Woodcock.
Page 35 and 36: ISPE PQLI on QbD, Sept. 14, 2007
Page 37: Overview of QbD Labeled Use Safety
Page 41 and 42: Identifying Critical Material Attri
Page 43 and 44: Critical Quality Attribute • “A
Page 45 and 46: Design Space • Design Space - The
Page 47 and 48: Controlling Input Materials and Man
Page 49 and 50: QbR Questions Provides a Roadmap
Page 51 and 52: How Does QbR Implement QbD Product
Page 53 and 54: How Does QbR Implement QbD Material
Page 55 and 56: How Does QbR Implement QbD Process
Page 57 and 58: Conclusion • The FDA OGD has deve
Page 59 and 60: 2.3.P.2.4 Container Closure System
Page 61 and 62: 添付資料 4-e FDA 新医薬

OPS/OC/ONDQA/OGD - NIHS

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