Guidelines for the quality control of population pharmacokinetic- pharmacodynamic analyses: An industry perspective

AAPS Journal

Volumn 14, Issue 4, 2012, Pages 749-758

  Bonate, P L ^a   Strougo, A ^b   Desai, A ^a   Roy, M ^a   Yassen, A ^b   Van Der Walt, J S ^b   Kaibara, A ^c   Tannenbaum, S ^a  

^a ASTELLAS PHARMA GLOBAL DEVELOPMENT   (United States)

^b Astellas Pharma Global Development   (Netherlands)

^c ASTELLAS PHARMA INC   (Japan)

Author keywords

Modeling; NONMEM; Quality assurance

Indexed keywords

ACCURACY; ANALYTICAL ERROR; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; GOOD CLINICAL PRACTICE; NONBIOLOGICAL MODEL; PEER REVIEW; PHARMACOLOGICAL PARAMETERS; POPULATION PHARMACOKINETIC PHARMACODYNAMIC ANALYSIS; PRACTICE GUIDELINE; QUALITY CONTROL; REVIEW; SIMULATION;

DRUG DESIGN; DRUG INDUSTRY; GUIDELINES AS TOPIC; HUMANS; MODELS, BIOLOGICAL; NONLINEAR DYNAMICS; QUALITY CONTROL;

EID: 84869127348     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-012-9387-9     Document Type: Review

References (16)

1. Keizer RJ, van Benten M, Beijnen JH, Schellens JH, Huitema AD. Piraña and PCluster: a modeling environment and cluster infrastructure for NONMEM. Computer Methods and Programs in Biomedicine. 2011;101:72-9.
2. Beal SL. Validation of a population model. NONMEM Topic 006: NONMEM Users Group e-mail discussion. 1994.
3. Bruno R, Vivier N, Vergniol JC, De Phillips SL, Montay G, Shiener LB. A population pharmacokinetic model for docetaxel (Taxotere): model building and validation. J Pharmacokinet Biopharm. 1996;24:153-72.
4. Chen C. Validation of a population pharmacokinetic model for adjunctive lamotrigine therapy in children. Br J Clin Pharmacol. 2000;50:135-45.
5. Cobelli C, Carson ER, Finkelstein L, Leaning MS. Validation of simple and complex models in physiology and medicine. Am J Physiol. 1984;246:R259-66.
6. U.S. Department of Health and Human Services, Division of Drug Information, Center for Drug Evaluation and Research, and Food and Drug Administration. Guidance for Industry-Providing Regulatory Submissions in Electronic Format-Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications. http://www.fda.gov/ RegulatoryInformation/Guidances/ucm126959.htm; 2005. Accessed 1 July 2012.
7. United States Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research. Guidance for industry: population pharmacokinetics. 1999.
8. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Statistical principles for clinical trials (E9). 1998.
9. Gorrell P. A SAS programmers guide to project and program-level quality control. Northeast SAS Users Group (NESUG) 18; 2005.
10. Bonate PL. Consistency of NONMEM parameter estimates across platforms and compilers. Presented at the Annual Meeting of the American Association of Pharmaceutical Scientists, Toronto, Canada; 2002.
11. Frame B, Koup J, Miller R, Lalonde R. Population pharmacokinetics of clinafloxacin in healthy volunteers and patients with infections: experience with heterogeneous pharmacokinetic data. Clin Pharmacokinet. 2001;40:307-15.
12. European Medicines Agency (EMEA) and Committee for Medicinal Products for Human Use (CHMP). Guideline on the reporting the results of population pharmacokinetic analyses. http://www.emea.europa.eu/pdfs/human/ewp/ 18599006enfin.pdf; 2007.
13. Edholm M. Modeling and simulation examples that failed to meet regulator's expectations. Presented at European Medicines Agency-European Federation of Pharmaceutical Industries and Associations Modelling and Simulation Workshop, November 2011; 2011.
14. McCulley/Cuppan. Improving the review process and review outcomes; 2011.
15. Bernhardt S. Improving document review processes in pharmaceutical companies. J Bus Tech Commun. 2003;17:439-73.
16. Lesko L, Williams R. The question based review. Applied Clinical Trials. 1999;8:56-62.