Applications of IVIVC in Formulation Development - PQRI

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Setting of Dissolution Specifications Dissolution at Release Dissolution at Release (%) and After 3 Months (%) Time (Hr) Mean -10% +10% -3 SD +3 SD Mean - 3SD +3 SD 2 21 11 31 15 27 22 16 28 4 53 43 63 47 59 54 49 59 5 64 54 74 58 70 65 60 69 8 85 75 95 78 92 86 82 91 12 97 87 107 90 104 98 93 103 Simulated Bioavailability Parameters Parameter Mean -10% +10% -3 SD +3 SD Mean - 3SD +3 SD AUC 69.8 62.7 77.0 64.9 73.9 69.6 65.0 73.6 % Diff from Mean -- 10.2 10.4 7.0 6.0 -- 6.6 5.6 % Diff Low to High -- 18.6 12.2 -- 11.6 Cmax 2.76 2.47 3.04 2.55 2.97 2.76 2.64 2.89 % Diff from Mean -- 10.4 10.2 7.6 7.5 -- 4.2 4.8 % Diff Low to High -- 18.8 14.1 -- 8.6
Case Study 2 BCS Class II Drug Highly variable pharmacokinetics AUC and Cmax dependent upon input rate Reformulation of generic formulation to IR reference drug products at three dose levels Controlled release required to achieve bioequivalence to reference drug product IVIVC desired to support change in tablet coating and change in site of manufacture
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: Level A IVIVC Validation - Acetate
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

Applications of IVIVC in Formulation Development - PQRI

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