Impact of biopharmaceutics classification system-based biowaivers

Molecular Pharmaceutics

Volumn 7, Issue 5, 2010, Pages 1539-1544

  Cook, Jack A ^a   Davit, Barbara M ^b   Polli, James E ^c  

^a PFIZER INC   (United States)

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

^c UNIVERSITY OF MARYLAND SCHOOL OF PHARMACY   (United States)

Author keywords

bioequivalence; Biopharmaceutics Classification System; biowaiver; cost; highly variable drugs

Indexed keywords

GENERIC DRUG; NEW DRUG;

BIOEQUIVALENCE; DRUG CLASSIFICATION; DRUG EXPOSURE; ECONOMIC ASPECT; PHARMACEUTICS; PRIORITY JOURNAL; REVIEW;

BIOPHARMACEUTICS; CHEMISTRY, PHARMACEUTICAL; COST SAVINGS; DRUG COSTS; DRUG DISCOVERY; DRUG EVALUATION; HUMANS; PHARMACEUTICAL PREPARATIONS; THERAPEUTIC EQUIVALENCY;

EID: 77957727096     PISSN: 15438384     EISSN: 15438392     Source Type: Journal    
DOI: 10.1021/mp1001747     Document Type: Review

References (26)

1. Cook, J. A.; Bockbrader, H. N. An industrial implementation of the biopharmaceutics classification system Dissolution Technol. 2002, 9, 6-9
2. Yu, L. X.; Amidon, G. L.; Polli, J. E.; Zhao, H.; Mehta, M. U.; Conner, D. P.; Shah, V. P.; Lesko, L. J.; Chen, M. L.; Lee, V. H.; Hussain, A. S. Biopharmaceutics classification system: the scientific basis for biowaiver extensions Pharm. Res. 2002, 19, 921-925
3. Jantratid, E.; Prakongpan, S.; Amidon, G. L.; Dressman, J. B. Feasibility of biowaiver extension to Biopharmaceutics classification system class III drug products: cimetidine Clin. Pharmacokinet. 2006, 45, 385-399
4. Polli, J. E.; Abrahamsson, B. S.; Yu, L. X.; Amidon, G. L.; Baldoni, J. M.; Cook, J. A.; Fackler, P.; Hartauer, K.; Johnston, G.; Krill, S. L.; Lipper, R. A.; Malick, W. A.; Shah, V. P.; Sun, D.; Winkle, H. N.; Wu, Y.; Zhang, H. Summary workshop report: bioequivalence, Biopharmaceutics classification system, and beyond AAPS J. 2008, 10, 373-379
5. Anonymous. "Annex 7: Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability". In WHO Expert Committee on Specifications for Pharmaceutical Preparations: Fortieth Report; WHO: Geneva, Switzerland, 2006; pp 347 - 390. http://whqlibdoc.who.int/trs/WHO-TRS-937-eng.pdf (accessed March 19, 2010).
6. Committee for Medicinal Products for Human Use. Guideline on the investigation of bioequivalence Jan. 20, 2010. http://www.ema.europa.eu/pdfs/ human/qwp/140198enrev1fin.pdf (accessed March 19, 2010).
7. Polli, J. E. In vitro studies are sometimes better than conventional human pharmacokinetic in vivo studies in assessing bioequivalence of immediate-release solid oral dosage forms AAPS J. 2008, 10, 289-299
8. Takagi, T.; Ramachandran, C.; Bermejo, M.; Yamashita, S.; Yu, L. X.; Amidon, G. L. A provisional biopharmaceutical classification of the top 200 oral drug products in the United States, Great Britain, Spain, and Japan Mol. Pharmaceutics 2006, 3, 631-643
9. Lindenberg, M.; Kopp, S.; Dressman, J. B. Classification of orally administered drugs on the World Health Organization Model list of Essential Medicines according to the Biopharmaceutics classification system Eur. J. Pharm. Biopharm. 2004, 58, 265-278
10. Kasim, N. A.; Whitehouse, M.; Ramachandran, C.; Bermejo, M.; Lennernäs, H.; Hussain, A. S.; Junginger, H. E.; Stavchansky, S. A.; Midha, K. K.; Shah, V. P.; Amidon, G. L. Molecular properties of WHO essential drugs and provisional biopharmaceutical classification Mol. Pharmaceutics 2004, 12, 85-96
11. Wu, C. Y.; Benet, L. Z. Predicting drug disposition via application of BCS: transport/absorption/ elimination interplay and development of a biopharmaceutics drug disposition classification system Pharm. Res. 2005, 22, 11-23
12. Khandelwal, A.; Bahadduri, P. M.; Chang, C.; Polli, J. E.; Swaan, P. W.; Ekins, S. Computational models to assign Biopharmaceutics drug disposition classification from molecular structure Pharm. Res. 2007, 24, 2249-2262
13. Haidar, S. H.; Davit, B.; Chen, M. L.; Conner, D.; Lee, L.; Li, Q. H.; Lionberger, R.; Makhlouf, F.; Patel, D.; Schuirmann, D. J.; Yu, L. X. Bioequivalence approaches for highly variable drugs and drug products Pharm. Res. 2008, 25, 237-241
14. Benet, L., Therapeutic Considerations of Highly Variable Drugs. FDA Advisory Committee for Pharmaceutical Science Meeting Transcript, October 6, 2006. http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4241s2-index.htm (accessed March 19, 2010).
15. Davit, B. M.; Conner, D. P.; Fabian-Fritsch, B.; Haidar, S. H.; Jiang, X.; Patel, D. T.; Seo, P. R.; Suh, K.; Thompson, C. L.; Yu, L. X. Highly variable drugs: observations from bioequivalence data submitted to the FDA for new generic drug applications AAPS J. 2008, 148-156
16. Tanguay, M.; Potvin, D.; Haddad, J.; Lavigne, J.; Marier, J. F.; DiMarco, M.; Ducharme, M. P. When will a drug formulation pass or fail bioequivalence criteria? Experience from 1200 studies AAPS PharmSci. 2002, 4 (S1) Abstract R6193
17. U.S. Food and Drug Administration. Drugs@FDA: FDA approved drug products. http://www.accessdata.fda.gov/scripts/cder/drugsatfda (accessed March 19, 2010).
18. US Food and Drug Administration. Guidance for industry: Food-effect bioavailability and fed bioequivalence studies. http://www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070241.pdf (accessed May 14, 2010).
19. Kola, I.; Landis, J. Can the pharmaceutical industry reduce attrition rates Nat. Rev. Drug Discovery 2004, 3, 711-715
20. Kaitin, K. I. Obstacles and opportunities in new drug development Clin. Pharmacol. Ther. 2008, 83, 210-212
21. U.S. Government Printing Office. Code of Federal Regulations Title 21 - Food and Drugs. Part 320 - Bioavailability and Bioequivalence Requirements. http://www.access.gpo.gov/nara/cfr/waisidx-03/21cfr320-03.html (accessed May 14, 2010).
22. DiLiberti, C. E. Why bioequivalence of highly variable drugs is an issue. Advisory Committee for Pharmaceutical Sciences Meeting Transcript, April 14, 2004. http://www.fda.gov/ohrms/dockets/ac/04/transcripts/4034T2.htm (accessed May 14, 2010).
23. US Food and Drug Administration. Critical Path Initiative Challenges and Opportunities Report-March 2004. http://www.fda.gov/ScienceResearch/ SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm077262. htm (accessed May 14, 2010).
24. US Food and Drug Administration. Guidance for industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/ucm070246.pdf (accessed May 14, 2010).
25. Anonymous. "Annex 7: Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability". In WHO Expert Committee on Specifications for Pharmaceutical Preparations: Fortieth Report; WHO: Geneva, Switzerland, 2006, pp 347 - 390. http://whqlibdoc.who.int/trs/WHO-TRS-937-eng.pdf (accessed May 14, 2010).
26. Japanese Institute of Health Sciences: Questions and answers to Guideline for Bioequivalence Test on Oral Solid Preparation with Different Drug Strengths and Guideline for Bioequivalence Test on Oral Solid Preparation for which the Formulation has been changed: http://www.nihs.go.jp/drug/be-guide/QA061124- ganryo-shoho.pdf (accessed May 14, 2010).