Summary Workshop Report: Facilitating oral product development and reducing regulatory burden through novel approaches to assess bioavailability/ bioequivalence

AAPS Journal

Volumn 14, Issue 3, 2012, Pages 627-638

  Polli, James E ^a   Cook, Jack A ^b   Davit, Barbara M ^c   Dickinson, Paul A ^d   Argenti, Domenick ^e   Barbour, Nancy ^f   García Arieta, Alfredo ^g   Geoffroy, Jean Marie ^h   Hartauer, Kerry ⁱ   Li, Shoufeng ^j   Mitra, Amitava ^k   Muller, Francis X ^l   Purohit, Vivek ^b   Sanchez Felix, Manuel ⁱ   Skoug, John W ^m   Tang, Kin ⁿ  

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

^b PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

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

^d ASTRAZENECA   (United Kingdom)

^e JANSSEN RESEARCH AND DEVELOPMENT   (United States)

^f BRISTOL MYERS SQUIBB   (United States)

^g Agencia Espanola de Medicamentos y Productos Sanitarios   (Spain)

^h TAKEDA PHARMACEUTICALS   (United States)

ⁱ ELI LILLY AND COMPANY   (United States)

^j NOVARTIS PHARMA AG   (Switzerland)

^k MERCK RESEARCH LABORATORIES   (United States)

^l GLAXOSMITHKLINE   (United States)

^m ABBOTT LABORATORIES   (United States)

ⁿ HOFFMANN LA ROCHE INC   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

DRUG; HIGHLY VARIABLE PRODUCT; METHYLPHENIDATE; NIFEDIPINE; ORAL DRUG PRODUCT; PALIPERIDONE; SPECIALIZED MODIFIED RELEASE PRODUCT; UNCLASSIFIED DRUG; ZOLPIDEM; ZOLPIDEM TARTRATE;

AREA UNDER THE CURVE; ATTENTION DEFICIT DISORDER; BIOEQUIVALENCE; CANADA; CONFERENCE PAPER; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG CONTROL; DRUG DESIGN; DRUG DEVELOPMENT; DRUG FORMULATION; DRUG QUALITY; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; HUMAN; INSOMNIA; MAXIMUM PLASMA CONCENTRATION; METHODOLOGY; MORNING DOSAGE; RISK ASSESSMENT; UNITED STATES; WORKSHOP;

ADMINISTRATION, ORAL; BIOLOGICAL AVAILABILITY; DRUG DESIGN; THERAPEUTIC EQUIVALENCY;

EID: 84862757971     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-012-9376-z     Document Type: Conference Paper

References (28)

1. LX Yu 2008 Pharmaceutical quality by design: product and process development, understanding, and control Pharm Res 25 781 91 10.1007/s11095-007- 9511-1 18185986 10.1007/s11095-007-9511-1 1:CAS:528:DC%2BD1cXkt1Sntrg%3D
2. Wilson W, Peng Y, Augsburger LL. Generalization of a prototype intelligent hybrid system for hard gelatin capsule formulation development. AAPS PharmSciTech. 2005. doi: 10.1208/pt060356.
3. M Rowland C Peck G Tucker 2011 Physiologically-based pharmacokinetics in drug 414 development and regulatory science Annu Rev Pharmacol Toxicol 51 45 73 20854171 10.1146/annurev-pharmtox-010510-100540 1:CAS:528:DC%2BC3MXisFOjurw%3D
4. N Penner L Xu C Prakash 2012 Radiolabeled absorption, distribution, metabolism, and excretion studies in drug development: why, when, and how? Chem Res Toxicol 25 513 31 10.1021/tx300050f 22309195 10.1021/tx300050f 1:CAS:528:DC%2BC38XhslGitLw%3D
5. X Ding J Rose J Van Gelder 2012 Developability assessment of clinical drug products with maximum absorbable doses Int J Pharm 427 260 9 22349050 10.1016/j.ijpharm.2012.02.003 1:CAS:528:DC%2BC38XjtF2hsbk%3D
6. Dickinson PA, Abu Rmaileh R, Ashworth L, Barker RA, Burke WM, Patterson CM, Stainforth N, Yasin M. An investigation into the utility of a multi-compartmental, dynamic, system of the upper gastrointestinal tract to support formulation development and establish bioequivalence of poorly soluble drugs. AAPS J. 2012;14:196-205. doi: 10.1208/s12248-012-9333-x.
7. CDER/FDA. Guidance for Industry, Q8(R2) Pharmaceutical development. November 2009. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM073507.pdf. Accessed 30 Apr 2012).
8. AS Rathore H Winkle 2009 Quality by design for biopharmaceuticals Nat Biotechnol 27 26 34 10.1038/nbt0109-26 19131992 10.1038/nbt0109-26 1:CAS:528:DC%2BD1MXis1yisA%3D%3D
9. R Dubey 2012 Bioequivalence challenges in development of fixed-dose combination products: looking beyond reformulation Expert Opin Drug Deliv 9 325 32 10.1517/17425247.2012.655723 22250699 10.1517/17425247.2012.655723 1:CAS:528:DC%2BC38Xis1aqsLY%3D
10. RL Wolen 1986 The application of stable isotopes to studies of drug bioavailability and bioequivalence Clin Pharmacol 26 419 24 1:CAS:528: DyaL28XkslWqsbk%3D
11. Cook JA. Development strategies for IVIVC in an industrial environment. Biopharm Drug Dispos. 2012. doi: 10.1002/bdd.1791.
12. Japan Institute of Health Sciences, Division of Drugs. Guideline for bioequivalence studies for formulation changes of oral solid dosage forms. December 2006. http://www.nihs.go.jp/drug/be-guide(e)/form-change2006e.pdf. Accessed 30 Apr 2012.
13. Purohit VS. Biopharmaceutic Planning in Pediatric Drug Development. AAPS J. 2012. doi: 10.1208/s1224801293643.
14. CDER/FDA. Guidance for Industry, waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a Biopharmaceutics Classification System. August 2000. http://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070246.pdf. Accessed 30 Apr 2012.
15. Dickinson PA, Lee WW, Stott PW, Townsend AI, Smart JP, Ghahramani P, Hammett T, Billett L, Behn S, Gibb RC, Abrahamsson B. Clinical relevance of dissolution testing in quality by design. AAPS J. 2008;10:380-90. doi: 10.1208/s12248-008-9034-7.
16. Cardot J-M, Davit BM. In vitro-in vivo correlations: tricks and traps. AAPS J. 2012. doi: 10.1208/s12248-012-9359-0.
17. Farrell C, Hayes S. IVIVC for oral drug delivery: immediate release and extended release dosage forms. In: Chilukuri DM, Sunkara G, Young D, editors. Pharmaceutical product development: in vitro-in vivo correlation. New York: Informa Healthcare; 2007. p. 125-40.
18. Qiu Y. In vitro-in vivo correlations: fundamentals, development considerations, and applications. In: Qiu Y, Chen Y, Zhang GZ, editors. Developing solid oral dosage forms: pharmaceutical theory and practice. Burlington: Academic; 2009. p. 379-408.
19. MN Samtani S Gopal C Gassmann-Mayer L Alphs JM Palumbo 2011 Dosing and switching strategies for paliperidone palmitate based on population pharmacokinetic modelling and clinical trial data CNS Drugs 25 829 45 21936586 1:CAS:528:DC%2BC3MXhsVOjsLrM
20. Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency (EMA). Guideline on the investigation of bioequivalence. January 20, 2010. http://www.emea.europa.eu/docs/en-GB/document-library/Scientific- guideline/2010/01/WC500070039.pdf. Accessed 30 Apr 2012.
21. BM Davit DP Conner B Fabian-Fritsch SH Haidar X Jiang, et al. 2008 Highly variable drugs: observations from bioequivalence data submitted to the FDA for new generic drug applications AAPS J 10 148 56 18446515 10.1208/s12248-008-9015- x 1:CAS:528:DC%2BD1cXhtVWrsLrF
22. Health Canada, Therapeutic Products Directorate. Conduct and analysis of bioavailability and bioequivalence studies-part B: oral modified release formulations. 1996.
23. L Endrenyi L Tothfalusi 2010 Do regulatory bioequivalence requirements adequately reflect the therapeutic equivalence of modified-release drug products? J Pharm Pharm Sci 13 107 13 20456835 1:CAS:528:DC%2BC3cXmslahtLs%3D
24. CDER/FDA. Briefing Information for the April 13, 2010 Meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee. http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ AdvisoryCommitteeforPharmaceuticalScienceandClinicalPharmacology/ucm207954.htm. Accessed 30 Apr 2012.
25. M-L Chen VP Shah D Ganes KK Midha J Caro P Nambiar, et al. 2010 Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified-release products: workshop summary report Eur J Pharm Sci 40 148 53 20347972 10.1016/j.ejps.2010.03.017 1:CAS:528:DC%2BC3cXlt1Smsbw%3D
26. E Gupta DM Barends E Yamashita KA Lentz AM Harmsze VP Shah JB Dressman RA Lipper 2006 Review of global regulations concerning biowaivers for immediate release solid oral dosage forms Eur J Pharm Sci 29 315 24 10.1016/j.ejps.2006. 05.001 16806858 10.1016/j.ejps.2006.05.001 1:CAS:528:DC%2BD28XhtFentrrE
27. A Selen MT Cruañes A Müllertz PA Dickinson JA Cook JE Polli F Kesisoglou J Crison KC Johnson GT Muirhead T Schofield Y Tsong 2010 Meeting report: applied biopharmaceutics and quality by design for dissolution/release specification setting: product quality for patient benefit AAPS J 12 465 72 10.1208/s12248-010-9206-0 20517660 10.1208/s12248-010-9206-0
28. JE Polli 2008 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 10 289 99 10.1208/s12248-008- 9027-6 18500564 10.1208/s12248-008-9027-6 1:CAS:528:DC%2BD1cXhtlOgsbvK