Applications of IVIVC in Formulation Development - PQRI

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Evaluation of Dissolution Specifications Time Point Statistical Limits – Statistical Limits – Passing L1 Passing L1 95% Chance of 99% Chance of Limits Based on IVIVC 2 hours NMT 33% NMT 34% 17 – 37% 4 hours 33 – 50% 32 – 51% 32 – 52% 8 hours 50 – 73% 50 – 75% 52 – 72% 12 hours 63 – 95% 63 – 95% 69 – 89% 24 hours NLT 83% NLT 82% NLT 87%
Case Study 5 BCS Class I Drug Development of IVIVC for Marketed MR Product Change in process Multiple strengths manufactured and exhibit same in vitro dissolution release profile Retrospective analysis of data available from 7 BA studies Drug has significant first-pass metabolism Data from intubation study indicated increase in systemic availability in distal GI Correlation model developed using dissolution data directly as input First derivative of Weibull Function
Page 1 and 2:
Application of IVIVCs in Formulatio
Page 3 and 4: Applications of IVIVC Understandin
Page 5 and 6: Practical Application: In Vivo and
Page 7 and 8: Plasma Concentrations Following Ora
Page 9 and 10: IVIVC Model - Water as Dissolution
Page 11 and 12: Level A IVIVC Validation - Water as
Page 13 and 14: IVIVC Model - Acetate Buffer as Dis
Page 15 and 16: Dissolution of Target Formulation -
Page 17 and 18: Level A IVIVC Validation - Acetate
Page 19 and 20: Case Study 2 BCS Class II Drug Hi
Page 21 and 22: Dissolution of Low Dose Reformulati
Page 23 and 24: Mean Dissolution and Absorption Pro
Page 25 and 26: Internal and External Predictabilit
Page 27 and 28: Dissolution Specifications For Low
Page 29 and 30: % Polymer Prediction Model to Achie
Page 31 and 32: Case Study 3 BCS Class I Drug Dev
Page 33 and 34: In Vitro / In Vivo Relationship for
Page 35 and 36: Demonstration of in vitro release i
Page 37 and 38: Internal Predictability Measures of
Page 39 and 40: MR Tablet Dissolution Profiles in 0
Page 41 and 42: 200 mg MR Tablet Dissolution Profil
Page 45 and 46: Approaches to a Level A IVIVC Trad
Page 47 and 48: MR Tablet Dissolution Profiles (Cum
Page 49 and 50: MR Tablets Absorption Profiles (Cum
Page 53: INTERNAL AND EXTERNAL PREDICTABILIT
Page 57 and 58: Model of Fraction of Drug Absorbed
Page 59 and 60: Validation of the Model
Page 61 and 62: Conclusions-Benefits of IVIVC Prov
Page 63: Acknowledgements Pharmaceutical Sc
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Applications of IVIVC in Formulation Development - PQRI

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