Utility of population pharmacokinetic modeling in the assessment of therapeutic protein-drug interactions

Journal of Clinical Pharmacology

Volumn 54, Issue 5, 2014, Pages 593-601

  Chow, Andrew T ^a   Earp, Justin C ^b   Gupta, Manish ^c   Hanley, William ^d   Hu, Chuanpu ^e   Wang, Diane D ^f   Zajic, Stefan ^d   Zhu, Min ^a  

^a AMGEN INC   (United States)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^c BRISTOL MYERS SQUIBB   (United States)

^d MERCK RESEARCH LABORATORIES   (United States)

^e JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^f PFIZER INC   (United States)

Author keywords

confirmatory PPK approach; drug drug interaction; population pharmacokinetic model; therapeutic protein; TP drug interaction

Indexed keywords

ARTICLE; DRUG INDUSTRY; DRUG INTERACTION; FOOD AND DRUG ADMINISTRATION; HUMAN; MODEL; POPULATION PHARMACOKINETIC MODELING; PROTEIN DRUG INTERACTION; STRATEGIC PLANNING; STUDY DESIGN; BIOLOGICAL MODEL;

PROTEIN;

DRUG INTERACTIONS; HUMANS; MODELS, BIOLOGICAL; PROTEINS;

EID: 84898624772     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1002/jcph.240     Document Type: Article

References (49)

1. US Food and Drug Administration (FDA). Draft guidance for industry: drug metabolism/drug interaction studies in the drug development process: studies in vitro. Rockville, MD: US Department of Health and Human Services; 1997. http://www.fda.gov/downloads/AboutFDA/CentersOffices/ OfficeofMedicalProductsandTobacco/CDER/UCM142439.pdf.
2. US Food and Drug Administration (FDA): Guidance for industry on in vivo drug metabolism/drug interaction studies-study design, data analysis, and recommendations for dosing and labeling. Rockville, MD: US Department of Health and Human Services; 1999.
3. Health Canada: Therapeutic products programme guidance document on drug-drug interactions: studies in vitro and in vivo. Ottawa, Ontario, 2000.
4. US Food and Drug Administration (FDA). Draft guidance for industry: drug interaction studies-study design, data analysis, and implications for dosing and labeling. Rockville, MD: US Department of Health and Human Services; 2006.
5. EMA guideline on the investigation of drug interactions (draft, April 2010).
6. US Food and Drug Administration (FDA). Draft guidance for industry (for comment only): drug interaction studies-study design, data analysis, and implications for dosing and labeling. Rockville, MD: US Department of Health and Human Services; 2012. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM292362.pdf.
7. Seitz K, Zhou H., Pharmacokinetic drug-drug interaction potentials for therapeutic monoclonal antibodies: reality check. J Clin Pharmacol. 2007; 47 (9): 1104-1118.
8. Mahmood I, Green MD., Drug interaction studies of therapeutic proteins or monoclonal antibodies. J Clin Pharmacol. 2007; 47 (12): 1540-1554. (Pubitemid 350115304)
9. Lee JIK, Zhang L, Men AY, et al., CYP-mediated therapeutic protein-drug interactions: clinical findings, proposed mechanisms and regulatory implications. Clin Pharmacokinet. 2010; 49 (5): 295-310.
10. Williams SJ, Farrell GC., Inhibition of antipyrine metabolism by interferon. Br J Clin Pharmacol. 1986; 22 (5): 610-612. (Pubitemid 17177041)
11. Williams SJ, Baird-Lambert JA, Farrell GC., Inhibition of theophylline metabolism by interferon. Lancet. 1987; 2 (8565): 939-941. (Pubitemid 17150287)
12. Strehlau J, Pape L, Offner G, et al. Interleukin-2 receptor antibody-induced alterations of cyclosporine dose requirements in paediatric transplant recipients. Lancet. 2000; 356 (9238): 1327-1328.
13. Schmitt C, Kuhn B, Zhang X, et al. Disease-drug-drug-interaction involving tocilizumab and simvastatin in patients with rheumatoid arthritis. Clin Pharmacol Ther. 2011; 89 (5): 735-740.
14. Krieckaert CL, Nurmohamed MT, Wolbink GJ., Methotrexate reduces immunogenicity in adalimumab treated rheumatoid arthritis patients in a dose dependent manner. Ann Rheum Dis. 2012, 71 (11): 1914-1915.
15. US food and drug administration postmarketing requirements and commitments. http://www.accessdata.fda.gov/Scripts/cder/pmc/index.cfm.
16. Evers R, Dallas S, Dickmann LJ, et al. Critical review of preclinical approaches to investigate cytochrome P450-mediated therapeutic protein drug-drug interactions and recommendations for best practices: a white paper. Drug Metab Dispos. 2013; 41 (9): 1598-1609.
17. Wang D, Zhu, M, Kassir N, et al. The utility of a population approach in DDI assessments: an evaluation using simulation approaches. Abstract and poster (M-027) presented at 2013 American Conference on Pharmacometrics.
18. Kenny JR, Liu MM, Chow AT, et al. Therapeutic protein drug-drug interactions: navigating the knowledge gaps-highlights from the 2012 AAPS NBC roundtable and IQ Consortium/FDA workshop. AAPS J. 2013; 15 (4): 933-940.
19. Huang S-M, Temple R, Throckmorton DD, et al., Drug interaction studies: study design, data analysis, and implications for dosing and labeling. Clin Pharmacol Ther. 2007, 81 (2): 298-304. (Pubitemid 46174829)
20. Kraynov E, Martin SW, Hurst S, et al. How current understanding of clearance mechanisms and pharmacodynamics of therapeutic proteins can be applied for evaluation of their drug-drug interaction potential. Drug Metab Dispos. 2011; 39 (10): 1779-1783.
21. FDA guidance for industry on population pharmacokinetics. 1999. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/ucm072137.pdf.
22. Zhou H., Population-based assessments of clinical drug-drug interactions: qualitative indices or quantitative measures ? J Clin Pharmacol. 2006; 46 (11): 1268-1289. (Pubitemid 44564356)
23. Perez Ruixo JJ, Ma P, Chow AT., The utility of modeling and simulation approaches to evaluate immunogenicity effect on the therapeutic protein pharmacokinetics. AAPS J. 2013; 15 (1): 172-182.
24. Duan JZ., Drug-drug interaction pattern recognition. Drugs R D. 2010; 10 (1): 9-24.
25. Duan, JZ., Applications of population pharmacokinetics in current drug labeling. J Clin Pharm Ther. 2007; 32 (1): 57-79. (Pubitemid 46213942)
26. Bristol-Myers Squibb: Abatacept Package Insert; Revised in Dec 2010; Download in Dec 2012, http://packageinserts.bms.com/pi/pi-orencia.pdf.
27. Genentech: TocilizumabPackage Insert, Download in Dec 2012 http://www.accessdata.fda.gov/drugsatfda-docs/label/2010/125276lbl.pdf.
28. Bruno R., Washington CB, Lu JF, et al. Population pharmacokinetics of trastuzumab in patients with HER2+ metastatic breast cancer. Cancer Chemother Pharmacol. 2005; 56 (4): 361-369. (Pubitemid 41095399)
29. Xu Z., Seitz K, Fasanmade A, et al. Population pharmacokinetics of infliximab in patients with ankylosing spondylitis. J Clin Pharmacol. 2008; 48 (6): 681-695. (Pubitemid 351713154)
30. Zhou, H., Mayer PR, Wajdula J, et al. Unaltered etanercept pharmacokinetics with concurrent methotrexate in patients with rheumatoid arthritis. J Clin Pharmacol. 2004; 44 (11): 1235-1243. (Pubitemid 39391482)
31. Xu Z, Vu T, Lee H, et al. Population pharmacokinetics of golimumab, an anti-tumor necrosis factor-alpha human monoclonal antibody, in patients with psoriatic arthritis. J Clin Pharmacol. 2009; 49 (9): 1056-1070.
32. Kovarik JM, Kalbag J, Figueiredo J, et al. Differential influence of azathioprine and mycophenolatemofetil on the disposition of basiliximab in renal transplant patients. Clin Transplant. 2001; 15 (2): 123-130. (Pubitemid 32229801)
33. Novartis: Basiliximab label, Revised in Jan 2003; Download in Dec 2012. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/ HowDrugsareDevelopedandApproved/ApprovalApplications/ TherapeuticBiologicApplications/ucm113375.pdf.
34. Lloyd P, Zhou H, Theil FP, et al. Pharmacokinetics and Disposition Expert Working Group drug-drug interaction taskforce highlights from a recent BIO survey on therapeutic protein-drug interactions. J Clin Pharmacol. 2012, 52: 1755-1763.
35. Hu C, Dong Y., Estimating the predictive quality of dose-response after model selection. Stat Med. 2007; 26 (16): 3114-3139. (Pubitemid 47019010)
36. FDA Clinical Pharmacology Review for Jevtana Kit (Cabazitaxel) on http://www.accessdata.fda.gov/scripts/cder/drugsatfda/.
37. Hu C, Moore, K., Kim, Y., Sale, M., Statistical issues in a modeling approach to assessing bioequivalence or PK similarity with presence of sparsely sampled subjects, J Pharmacokinet Pharmacodyn. 2004; 33 (4): 321-339. (Pubitemid 39287339)
38. Kowalski KG, Hutmacher MM., Design evaluation for a population pharmacokinetic study using clinical trial simulations: a case study. Stat Med. 2001; 20 (1): 75-91.
39. Silber HE, Kjellsson MC, Karlsson MO., The impact of misspecification of residual error or correlation structure on the type I error rate. J Pharmacokinet Pharmacodyn. 2009; 36 (1): 81-99.
40. Seber GAF, Wild CJ, Nonlinear regression. Hoboken, New Jersey, USA; John Wiley & Sons, Inc., 2005.
41. Kang D, Schwartz JB, Verotta D., A sample size computation method for non-linear mixed effects models with applications to pharmacokinetics models. Stat Med. 2004; 23 (16): 2551-2566. (Pubitemid 39149267)
42. Retout S, Comets E, Samson A, et al. Design in nonlinear mixed effects models: optimization using the Fedorov-Wynn algorithm and power of the Wald test for binary covariates. Stat Med 2007; 26 (28): 5162-5179. (Pubitemid 350148473)
43. Efron, B, Tibshirani, R, An introduction to the bootstrap. Florida, USA: CRC Press; 1993.
44. Hu C, Xu Z, Rahman M, et al., A latent variable approach for modeling categorical endpoints among patients with rheumatoid arthritis treated with golimumab plus methotrexate, J Pharmacokinet Pharmacodyn. 2010; 37 (4): 309-321.
45. Savic RM, Wilkins JJ, Karlsson MO., (Un)informativeness of empirical Bayes estimate-based diagnostics. AAPS J. 2006; 8, No. S2, Abstract T3360 (2006): American Association of Pharmaceutical Scientists.
46. Hu C, Zhang J, Zhou H., Confirmatory analysis for phase III population pharmacokinetics. Pharm Stat. 2011; 10 (1): 14-26.
47. Hu C, Zhou H., An improved approach for confirmatory phase III population pharmacokinetic analysis. J Clin Pharmacol. 2008; 48 (7): 812-822. (Pubitemid 351871963)
48. Zhu Y, Hu C, Lu M, et al. Population pharmacokinetic modeling of ustekinumab, a human monoclonal antibody targeting IL-12/23p40, in patients with moderate to severe plaque psoriasis. J Clin Pharmacol. 2009; 49 (2): 162-175.
49. FDA guidance for industry on Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products-Content and Format. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/ucm109739.pdf.