Applications of IVIVC in Formulation Development - PQRI

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In Vitro/In Vivo Correlations - Goals Establish a correlation between in vitro drug dissolution and in vivo drug absorption Develop a model that can accurately predict bioavailability characteristics for a drug product based on dissolution profile characteristics
Applications of IVIVC Understanding key formulation variable(s) Biowaivers for changes in drug product Lower strengths New strengths Changes in components and/or composition (within SUPAC guidelines) - Release rate controlling - Non-release rate controlling Changes in manufacturing site, process and/or equipment (within SUPAC guidelines) Setting dissolution specifications Justification of limits other than +/-10%
Page 1: Application of IVIVCs in Formulatio
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 and 54:
INTERNAL AND EXTERNAL PREDICTABILIT
Page 55 and 56:
Case Study 5 BCS Class I Drug Dev
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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