Applications of IVIVC in Formulation Development - PQRI

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IVIVC Validation Internal Validation Predict plasma concentration-time profiles, C max and AUC values using in vitro dissolution data for the formulations that were used to develop the IVIVC Average absolute percent prediction error (%PE) of 10% or less for C max and AUC and no individual %PE of individual formulation more than 15% validates IVIVC External Validation Predict plasma concentration-time profiles, C max and AUC values using in vitro dissolution data for a formulation that was not used in the development of IVIVC %PE of 10% or less for C max and AUC validates IVIVC Proof of external validation provides greater confidence in IVIVC than internal validation
Level A IVIVC Validation – Water as Dissolution Medium Internal Predictability Formula Obs AUC Pred AUC %PE Obs C max Pred C max %PE Slow Release Fast Release 63.4 66.0 4.15 1.77 2.02 14.3 74.1 78.2 5.54 3.45 3.00 13.2 Average %PE 4.84 Average %PE 13.7 External Predictability Formula Obs AUC Pred AUC %PE Obs C max Pred C max %PE Medium Release 66.8 67.2 0.67 2.26 2.22 1.77 AUC units: ng-hr/mL, C max units: ng/mL
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: IVIVC Model - Water as Dissolution
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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