a step guide for "in vitro in vivo correlation ship (ivivc)" by shivang chaudhary
TRANSCRIPT
© Created & Copyrighted by Shivang Chaudhary
A STEP GUIDE FOR IN VITRO IN VIVO CORRELATIONSHIP FOR PHARMACEUTICAL PRODUCT DEVELOPMENT AS PER QbD
SHIVANG CHAUDHARY
© Copyrighted by Shivang Chaudhary
Quality Risk Manager & Intellectual Property Sentinel- CIIE, IIM Ahmedabad MS (Pharmaceutics)- National Institute of Pharmaceutical Education & Research (NIPER), INDIA
PGD (Patents Law)- National academy of Legal Studies & Research (NALSAR), INDIA
+91 -9904474045, +91-7567297579 [email protected]
https://in.linkedin.com/in/shivangchaudhary
facebook.com/QbD.PAT.Pharmaceutical.Development
PRODUCT REGISTRATION
PROCESS SCALE UP
PROSPECTIVE IVIVC
RETROSPECTIVE IVIVC
ASSUMED IN VITRO IN VIVO CORRELATIONSHIP
iViVC STEP GUIDE
© Created & Copyrighted by Shivang Chaudhary
For establishment of THEORETICAL In-Vitro TARGETS
Drug Substance to Drug Product
PRODUCT REGISTRATION
PROCESS SCALE UP
ASSUMED IVIVC
iViVC STEP GUIDE
© Created & Copyrighted by Shivang Chaudhary
PROSPECTIVE IVIVC
RETROSPECTIVE IN VITRO IN VIVO CORRELATIONSHIP
For establishment of PRACTICAL In-Vitro TARGETS
Cp DeConvolution
t
Ab
t
$In Vitro Dissolution profiling generated in different pH of media, different dissolution volume, different speed of dissolution apparatus, different dissolution apparatus to compare with In vivo absorption time profile for correlation analysis
Wagner Nelson or Loo Riegelman Method
Time(hrs) Cp (ug/L) [AUC]t n
t n–1 [AUC]
t 0 Ke [AUC]
t 0
C p + k[AUC]
t 0 Ab/Abinf PDA
PRODUCT REGISTRATION
ASSUMED IVIVC
iViVC STEP GUIDE
© Created & Copyrighted by Shivang Chaudhary
RETROSPECTIVE IVIVC
PROCESS SCALE UP
PROSPECTIVE IN VITRO IN VIVO CORRELATIONSHIP
For FORMULATION OPTIMIZATION & Model Validation
Convolution Cp
t
Dd
t
PRODUCT REGISTRATION
ASSUMED IVIVC
iViVC STEP GUIDE
© Created & Copyrighted by Shivang Chaudhary
RETROSPECTIVE IVIVC
PROSPECTIVE IVIVC
PILOT SCALE UP WITH PROCESS OPTIMIZATION
For PROCESS OPTIMIZATION & Pivotal batches with Pharmacokinetic Studies
ASSUMED IVIVC
iViVC STEP GUIDE
© Created & Copyrighted by Shivang Chaudhary
RETROSPECTIVE IVIVC
PROSPECTIVE IVIVC
PROCESS SCALE UP
PRODUCT
REGISTRATION
Product REGISTRATION/ Filing for CHANGES after approval
by SUPAC with IVIVC Model
THANK YOU SO MUCH FROM
DESIGNING IS A JOURNEY OF DISCOVERY…
© Created & Copyrighted by Shivang Chaudhary
SHIVANG CHAUDHARY
© Copyrighted by Shivang Chaudhary
Quality Risk Manager & Intellectual Property Sentinel- CIIE, IIM Ahmedabad MS (Pharmaceutics)- National Institute of Pharmaceutical Education & Research (NIPER), INDIA
PGD (Patents Law)- National academy of Legal Studies & Research (NALSAR), INDIA
+91 -9904474045, +91-7567297579 [email protected]
https://in.linkedin.com/in/shivangchaudhary
facebook.com/QbD.PAT.Pharmaceutical.Development