Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: Impact of FDA pharmacometrics during 2004-2006

Journal of Clinical Pharmacology

Volumn 48, Issue 2, 2008, Pages 146-156

  Wang, Yaning ^a   Venkatesh Bhattaram, A ^a   Jadhav, Pravin R ^a   Lesko, Lawrence J ^a   Madabushi, Rajanikanth ^a   Powell, J Robert ^a   Qiu, Wei ^a   Sun, He ^a   Yim, Dong S ^a   Zheng, Jenny J ^a   Gobburu, Jogarao V S ^a  

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

Author keywords

Drug development; EOP2A meeting; FDA; Modeling; Pharmacodynamics; Pharmacokinetics; Pharmacometrics; Regulatory decisions; Simulation

Indexed keywords

ANTICOAGULANT AGENT; ANTINEOPLASTIC AGENT; ANTIVIRUS AGENT; GLUCOSE; HEMOGLOBIN A1C; PLACEBO; ZOLPIDEM;

ANTICOAGULANT THERAPY; AREA UNDER THE CURVE; ARTICLE; CLINICAL DECISION MAKING; CLINICAL PRACTICE; CLINICAL TRIAL; DEEP VEIN THROMBOSIS; DISEASE COURSE; DRUG ACTIVITY; DRUG DESIGN; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG INDICATION; DRUG INDUSTRY; DRUG LEGISLATION; DRUG QUALITY; DRUG RESEARCH; DRUG SAFETY; EPILEPSY; FOOD AND DRUG ADMINISTRATION; GLUCOSE BLOOD LEVEL; HEALTH PROGRAM; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFECTION; INSOMNIA; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTCOME ASSESSMENT; PAIN; PRACTICE GUIDELINE; PROSTATE CANCER; RATING SCALE; SIMULATION; SLEEP DISORDER; VASOMOTOR DISORDER; WEIGHT REDUCTION;

CLINICAL TRIALS AS TOPIC; DECISION MAKING; DRUG APPROVAL; DRUG INDUSTRY; GOVERNMENT REGULATION; GUIDELINES AS TOPIC; HUMANS; INVESTIGATIONAL NEW DRUG APPLICATION; LEGISLATION, DRUG; ORGANIZATIONAL OBJECTIVES; TIME FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 38349115335     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270007311111     Document Type: Article

References (20)

1. Food and Drug Administration. Innovation or stagnation: challenges and opportunity on the critical path to new medical products, March 2004. http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html. Accessed December 15, 2007.
2. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Concept Paper: End-of-Phase-2A meetings with sponsors regarding exposure-response of IND and NDA products. October 2003. http://www.fda.gov/ohrms/dockets/ac/03/briefing/ 3998B1_01_Topic%201-Part%20A.pdf. Accessed December 15, 2007.
3. Bhattaram VA, Booth BP, Ramchandani RP, et al. Impact of pharmacometrics on drug approvals and labeling decisions: survey of 42 new drug applications. AAPS J. 2005 ; 7 (3). E503 - E512. Review.
4. Bhattaram VA, Bonapace C., Chilukuri DM, et al. Impact of pharmacokinetic review on new drug approval and labeling decisions-a survey of 31 new drug applications submitted between 2005 and 2006. Clin Pharmacol Ther. 2007 ; 81: 213-221.
5. Lesko LJ Paving the critical path: how can clinical pharmacology help achieve the vision? Clin Pharmacol Ther. 2007 ; 81 (2). 170-117. Review.
6. Funk GA, Fischer M., Joos B., et al. Quantification of in vivo replicative capacity of HIV-1 in different compartments of infected cells. J Acquir Immune Defic Syndr. 2001 ; 26 (5). 397-404.
7. Kastrissios H., Blaschke TF Medication compliance as a feature in drug development. Annu Rev Pharmacol Toxicol. 1997 ; 37: 451-475. Review.
8. Hawley P., Amantea M., Poland B., et al. Integrated adherence, pharmacokinetic, and pharmacodynamic modeling to design a dose-ranging study of capravirine with kaletra in treatment-experienced patients. Poster presented at 4th International Workshop on the Clinical Pharmacology of HIV Therapy, Cannes, France, March 27-29, 2003. http://www.medadvocates.org/resources/conferences/ 4thPharmWkshp/indexkaletra.htm. Updated February 20, 2007. Accessed December 14, 2007.
9. Dayneka NL, Garg V., Jusko WJ Comparison of 4 basic indirect response models. J Pharmacokinet Biopharm. 1993 ; 21: 457-478.
10. Merlotti L., Roehrs T., Koshorek G., Zorick F., Lamphere J., Roth T. The dose effects of zolpidem on the sleep of healthy normals. J Clin Psychopharmacol. 1989 ; 9 (1). 9-14.
11. Scharf MB, Roth T., Vogel GW, Walsh JK A multicenter, placebo-controlled study evaluating zolpidem in the treatment of chronic insomnia. J Clin Psychiatry. 1994 ; 55 (5). 192-199.
12. DiMasi JA, Hansen RW, Grabowski HG The price of innovation: new estimates of drug development costs. J Health Econ. 2003 ; 22 (2). 151-185.
13. Russell J. Marvelous models of biological systems. Bio-IT World. February 15, 2006. http://www.bio-itworld.com/issues/2006/feb/cover-story-models/. Accessed December 15, 2007.
14. Proceedings of the Clinical Pharmacology Sub-Committee Advisory Committee Meeting. Oct 26, 2006. http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006- 4248B1-04-FDA-topic-3-replacement.pdf. Accessed December 15, 2007.
15. Zhang L., Sinha V., Forgue ST, et al. Model-based drug development: the road to quantitative pharmacology. J Pharmacokinet Pharmacodyn. 2006 ; 33 (3). 369-393.
16. Olson SC, Bockbrader H., Boyd RA, et al. Impact of population pharmacokinetic-pharmacodynamic analyses on the drug development process: experience at Parke-Davis. Clin Pharmacokinet. 2000 ; 38 (5). 449-459.
17. Reigner BG, Williams PE, Patel IH, Steimer JL, Peck C., van Brummelen P. An evaluation of the integration of pharmacokinetic and pharmacodynamic principles in clinical drug development. Experience within Hoffmann La Roche. Clin Pharmacokinet. 1997 ; 33 (2). 142-152.
18. Lalonde RL, Kowalski KG, Hutmacher MM, et al. Model-based drug development. Clin Pharmacol Ther. 2007 ; 82 (1). 21-32.
19. Miller R., Ewy W., Corrigan BW, et al. How modeling and simulation have enhanced decision-making in new drug development. J Pharmacokinet Pharmacodyn. 2005 ; 32 (2). 185-197. Review.
20. Powell JR, Gobburu JV Pharmacometrics at FDA: evolution and impact on decisions. Clin Pharmacol Ther. 2007 ; 82 (1). 97-102.