Physiologically based pharmacokinetics is impacting drug development and regulatory decision making

CPT: Pharmacometrics and Systems Pharmacology

Volumn 4, Issue 6, 2015, Pages 313-315

  Rowland, M ^a,b   Lesko, L J ^c   Rostami Hodjegan, A ^a,d  

^a UNIVERSITY OF MANCHESTER   (United Kingdom)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c UNIVERSITY OF FLORIDA   (United States)

^d CERTARA UK LIMITED   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ALLELE; CLINICAL DECISION MAKING; CLINICAL PHARMACOLOGY; COMPARTMENT MODEL; COMPUTER MODEL; CONCEPTUAL FRAMEWORK; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG DEVELOPMENT; DRUG DISTRIBUTION; DRUG EXCRETION; DRUG INDUSTRY; DRUG INTERACTION; DRUG METABOLISM; EUROPEAN MEDICINES AGENCY; FOOD AND DRUG ADMINISTRATION; GENETIC POLYMORPHISM; GERMLINE MUTATION; HUMAN; IN VITRO STUDY; INTRINSIC CLEARANCE; KIDNEY FUNCTION; LIVER CLEARANCE; PHARMACOGENOMICS; PHARMACOKINETICS; PHYSIOLOGICALLY BASED PHARMACOKINETICS; PRIORITY JOURNAL; PUBLICATION; REVIEW; TISSUE DISTRIBUTION;

EID: 84936773921     PISSN: None     EISSN: 21638306     Source Type: Journal    
DOI: 10.1002/psp4.52     Document Type: Review

References (4)

1. Wagner, C,. et al. Application of physiologically-based pharmacokinetic (PBPK) modeling to support dose selection-report of a FDA public workshop on PBPK. CPT Pharmacometrics Syst. Pharmacol 4, 226-230 (2015).
2. Shepard, T., Scott, G., Cole, S., Nordmark, A., &, Bouzom, F,. Physiologically based models in regulatory submissions: output from the ABPI/MHRA Forum on Physiologically Based Modelling and Simulation. CPT Pharmacometrics Syst. Pharmacol 4, 221-225 (2015).
3. Concept paper on qualification and reporting of physiologically based pharmacokinetic (PBPK) modelling and analyses. EMA/CHMP/211243/2014.
4. Guidance for Industry: Population Pharmacokinetics. U.S. Department of Health and Human Services, Food and Drug Administration, Washington DC. < http://www.fda.gov/downloads/Drugs/Guidances/UCM072137.pdf > (1999). Accessed 16 April 2015.