PMID- 30673891
OWN - NLM
STAT- MEDLINE
DCOM- 20200214
LR  - 20200309
IS  - 1550-7416 (Electronic)
IS  - 1550-7416 (Linking)
VI  - 21
IP  - 2
DP  - 2019 Jan 23
TI  - PBPK Absorption Modeling: Establishing the In Vitro-In Vivo Link-Industry 
      Perspective.
PG  - 19
LID - 10.1208/s12248-019-0292-3 [doi]
AB  - The establishment of an in vitro-in vivo correlation (IVIVC) is considered the 
      gold standard to establish in vivo relevance of a dissolution method and to 
      utilize dissolution data in the context of regulatory bioequivalence questions, 
      including the development of dissolution specifications. However, several recent 
      publications, including industry surveys and reviews from regulatory agencies, 
      have indicated a low success rate for IVIVCs, especially for immediate-release 
      formulations. In recent years, the use of physiologically based pharmacokinetics 
      (PBPK) and absorption modeling, as a tool to facilitate formulation development, 
      has been attracting increased attention. This manuscript provides an industry 
      perspective on the current challenges with establishing IVIVCs and the potential 
      PBPK and absorption modeling offer to increase their impact. Case studies across 
      both immediate-release and extended-release formulations from five pharmaceutical 
      companies are utilized to demonstrate how physiologically based IVIVC (PB-IVIVC) 
      may facilitate drug product understanding and to inform bioequivalence assessment 
      and clinically relevant specifications. Finally, PB-IVIVC best practices and a 
      strategy for model development and application are proposed.
FAU - Stillhart, Cordula
AU  - Stillhart C
AD  - Pharmaceutical Research & Development, Formulation & Process Sciences, F. 
      Hoffmann-La Roche Ltd., Basel, Switzerland.
FAU - Pepin, Xavier
AU  - Pepin X
AD  - AstraZeneca, Pharmaceutical Technology & Development, Silk Road Business Park, 
      Charter Way, Macclesfield, SK10 2NA, UK.
FAU - Tistaert, Christophe
AU  - Tistaert C
AD  - Pharmaceutical Sciences, Discovery, Product Development & Supply, Janssen 
      Research and Development, Beerse, Belgium.
FAU - Good, David
AU  - Good D
AD  - Drug Product Science and Technology, Bristol-Myers Squibb Co., P.O. Box 191, New 
      Brunswick, New Jersey, 08903-0191, USA.
FAU - Van Den Bergh, An
AU  - Van Den Bergh A
AD  - Pharmacodynamics, Pharmacokinetics, and Metabolism, Discovery, Product 
      Development & Supply, Janssen Research and Development, Beerse, Belgium.
FAU - Parrott, Neil
AU  - Parrott N
AD  - Pharmaceutical Sciences, Pharmaceutical Research and Early Development, Roche 
      Innovation Center Basel, Basel, Switzerland.
FAU - Kesisoglou, Filippos
AU  - Kesisoglou F
AD  - Biopharmaceutics and Specialty Dosage Forms, Pharmaceutical Sciences, Merck & 
      Co., Inc., 770 Sumneytown Pike, WP75B-210, West Point, Pennsylvania, 19486-0004, 
      USA. filippos_kesisoglou@merck.com.
LA  - eng
PT  - Journal Article
DEP - 20190123
PL  - United States
TA  - AAPS J
JT  - The AAPS journal
JID - 101223209
RN  - 0 (Biological Products)
RN  - 0 (Delayed-Action Preparations)
SB  - IM
MH  - *Absorption, Physiological
MH  - Administration, Oral
MH  - Biological Products/administration & dosage/*pharmacokinetics
MH  - Delayed-Action Preparations/administration & dosage/pharmacokinetics
MH  - Drug Development/methods/*standards
MH  - Drug Industry/*standards
MH  - Drug Liberation
MH  - Guidelines as Topic
MH  - Humans
MH  - *Models, Biological
MH  - Solubility
MH  - Therapeutic Equivalency
OTO - NOTNLM
OT  - IVIVC
OT  - oral absorption modeling
OT  - physiologically based absorption modeling
OT  - physiologically based biopharmaceutics modeling
OT  - physiologically based pharmacokinetics
EDAT- 2019/01/24 06:00
MHDA- 2020/02/15 06:00
CRDT- 2019/01/24 06:00
PHST- 2018/10/02 00:00 [received]
PHST- 2018/12/28 00:00 [accepted]
PHST- 2019/01/24 06:00 [entrez]
PHST- 2019/01/24 06:00 [pubmed]
PHST- 2020/02/15 06:00 [medline]
AID - 10.1208/s12248-019-0292-3 [pii]
AID - 10.1208/s12248-019-0292-3 [doi]
PST - epublish
SO  - AAPS J. 2019 Jan 23;21(2):19. doi: 10.1208/s12248-019-0292-3.