Best practices for the development, scale-up, and post-approval change control of IR and MR dosage forms in the current quality-by-design paradigm

AAPS PharmSciTech

Volumn 15, Issue 3, 2014, Pages 665-693

  Van Buskirk, Glenn A ^a   Asotra, Satish ^b   Balducci, Christopher ^c   Basu, Prabir ^d   DiDonato, Gerald ^e   Dorantes, Angelica ^f   Eickhoff, W Mark ^g   Ghosh, Tapash ^f   González, Mario A ^h   Henry, Theresa ⁱ   Howard, Matthew ^j   Kamm, Jason ^k   Laurenz, Steven ^l   MacKenzie, Ryan ^m   Mannion, Richard ⁿ   Noonan, Patrick K ⁱ   Ocheltree, Terrance ^f   Pai, Umesh ^o   Poska, Richard P ^l   Putnam, Michael L ^p   Raghavan, Ramani R ^q   Ruegger, Colleen ^c   Sánchez, Eric ^r   Shah, Vinod P ⁱ   Shao, Zezhi Jesse ^s   Somma, Russell ^t   Tammara, Vijay ^u   Thombre, Avinash G ^v   Thompson, Bruce ^g   Timko, Robert J ^w   Upadrashta, Satyam ^x   Vaithiyalingam, Sivakumar ^y   more..

^a Nonclinical Drug Development Consulting Services LLC   (United States)

^b AHI Inc   (Canada)

^c NOVARTIS PHARMA AG   (Switzerland)

^d National Institute of Pharmaceutical Technology and Engineering (NIPTE)   (United States)

^e BRISTOL MYERS SQUIBB   (United States)

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

^g MERCK RESEARCH LABORATORIES   (United States)

^h P'Kinetics International Inc   (United States)

ⁱ McNeil Consumer Healthcare ^*

^j McNeil Laboratories Inc   (United States)

^k Summit Pharma Solutions LLC   (United States)

^l ABBVIE INC   (United States)

^m JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

ⁿ PURDUE PHARMA L P   (United States)

^o Clinical Operations and Development Sun Pharma USA   (United States)

^p BOEHRINGER INGELHEIM VETMEDICA INC   (United States)

^q GENENTECH INC   (United States)

^r Janssen Ortho LLC   (Puerto Rico)

^s ARENA PHARMACEUTICALS   (United States)

^t Somma Tech Consulting   (United States)

^u Nuron Biotech   (United States)

^v PFIZER INC   (United States)

^w ASTRAZENECA   (United Kingdom)

^x MILLENNIUM PHARMACEUTICALS INC   (United States)

^y Teva Pharmaceuticals   (United States)

more..

Author keywords

CMC; ICH; IVIVC; PAT; QbD

Indexed keywords

DRUG DESIGN; DRUG DOSAGE FORM; DRUG INDUSTRY; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW; ANIMAL; CHEMISTRY; DELAYED RELEASE FORMULATION; DRUG APPROVAL; FOOD AND DRUG ADMINISTRATION; HUMAN; MEDICINAL CHEMISTRY; PHARMACEUTICS; PHARMACOKINETICS; PROCEDURES; RISK ASSESSMENT; SOLUBILITY; STANDARDS; TOXICOLOGY; UNITED STATES;

DELAYED RELEASE FORMULATION; DRUG; EXCIPIENT;

ANIMALS; BENCHMARKING; CHEMISTRY, PHARMACEUTICAL; DELAYED-ACTION PREPARATIONS; DRUG APPROVAL; DRUG INDUSTRY; EXCIPIENTS; HUMANS; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS; QUALITY CONTROL; RISK ASSESSMENT; SOLUBILITY; TECHNOLOGY, PHARMACEUTICAL; TOXICOLOGY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84901979478     PISSN: None     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/s12249-014-0087-x     Document Type: Review

References (37)

1. Skelly JP, Van Buskirk GA, Savello DR, Amidon GL, Arbit HM, Dighe S, et al. Scaleup of immediate release oral solid dosage forms. Pharm Res. 1993;10:313-6. (Pubitemid 23041751)
2. Skelly JP, Van Buskirk GA, Arbit HM, Amidon GL, Augsburger L, Barr WH, et al. Scaleup of oral extended-release dosage forms. Pharm Res. 1993;10(12):1800-5. (Pubitemid 24000370)
3. Communication from the Commission - Guideline on the details of the various categories of variations to the terms of marketing authorizations for medicinal products for human use and veterinary medicinal products. Off J Eur Union, 22.1.2010, C17/1-41. http://ec.europa.eu/health/files/eudralex/vol-2/c17- 1/c17-1-en.pdf.
4. Post-Notice of Compliance (NOC) Changes - quality guidance appendix 1 for human pharmaceuticals. Canada Ministry of Health, Health Products and Food Branch, Implementation 10/17/2011. http://www.hc-sc.gc.ca/dhp-mps/alt-formats/ hpfb-dgpsa/pdf/prodpharma/applic-demande/guide-ld/postnoc-change-apresac/ noc-pn-quality-ac-sa-qualite-eng.pdf.
5. FDA challenges and opportunities report - innovation or stagnation: challenge and opportunity on the critical path to new medical products. US Department of Health and Human Services, Food and Drug Administration, March 2004. http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/ CriticalPathOpportunitiesReports/ucm077262.htm.
6. International Conference on Harmonization Guideline ICH Q6A: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances. October 1999. http://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm134966.htm.
7. Lionberger RA, Lee SAU, Lee L, Rau A, Yu LX. Quality by design: concepts for ANDAs. AAPS J. 2008;10(2):268-88. doi:10.1208/s12248-008-9026-7.
8. FDA manual of policies and procedures. Center for Drug Evaluation and Research, Office of Pharmaceutical Science, MAPP 5016.1 - Applying ICH Q8(R2), Q9, and Q10 principle to CMC review. February 2011. http://www.fda.gov/ downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/UCM242665.pdf.
9. International Conference on Harmonization Guideline ICH Q8(2) - Pharmaceutical development. November 2008. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM073507.pdf.
10. International Conference onHarmonization Guideline ICHQ9 - quality risk management. November 2005. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM073511.pdf.
11. International Conference on Harmonization Guideline ICH Q10 - Pharmaceutical quality systems. June 2008. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM073517.pdf.
12. International Conference on Harmonization Guideline ICHQ11 - Development and manufacture of drug substances (Chemical entities and biotechnological/ biological entities). May 2012. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM261078.pdf.
13. Guidance for Industry: PAT - a framework for innovative pharmaceutical development, manufacturing, and quality assurance. September 2004. http://www.fda.gov/downloads/Drugs/.../Guidances/ucm070305.pdf.
14. United States Code of Federal Regulations, Title 21 - Food and drugs. Chapter 1 - Food and Drug Administration Department of Health and Human Services, Subchapter D - Drugs for human use, Part 314 - Applications for FDA approval to market a new drug, Subpart B - Applications, Section 314.70 - Supplements and other changes to an approved application.
15. Guidance for Industry: Changes to an approved NDA or ANDA, Revision 1. April 2004. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM077097.pdf.
16. Draft Guidance for Industry: CMC post-approval manufacturing changes reportable in annual reports. June 2010. http://www.fda.gov/downloads/ DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM217043.pdf
17. Health Canada Draft Quality (Chemistry and Manufacturing) Guidance: New drug submissions (NDSs) http://www.hc-sc.gc.ca/dhp-mps/alt-formats/hpfb-dgpsa/ pdf/prodpharma/qual-ndsands-pdnpadn-07-01-eng.pdf.
18. Abbreviated New Drug Submissions (SNDSs) rather than the PMNOC-QD, or stability data requirements as per Health Canada Guidance Stability Testing of Existing Drug Substances and Product http://www.hc-sc.gc.ca/dhp-mps/alt-formats/ hpfb-dgpsa/pdf/prodpharma/stabt-stabe-eng.pdf.
19. Post Authorization Procedural Advice on Variation Regulation (EC) No. 1234/2008. EMA/40404/2010 http://www.emea.europa.eu/docs/en-GB/document-library/ Regulatory-and-procedural-guideline/2010/01/WC500060512.pdf.
20. Public Consultation Paper - Review of the variations guidelines regulation (EC) No. 1234/2008 Article 4: Review of the variations guidelines European Commission, Health and Consumers Directorate - General Health Systems and Products Medicinal products - Authorizations, EMA, Brussels, Sanco.ddg1.d.5(2012)817838. http://ec.europa.eu/health/files/betterreg/2012-06- 11-public-consultation-en.pdf.
21. Guideline for descriptions on application forms for marketing approval of drugs, etc. under the revised pharmaceutical affairs law, PFSB/ELDnotification no. 0210001, February 10, 2005. http://www.pmda.go.jp/english/service/pdf/ guideline-application-2.pdf.
22. nd edition. Informa Healthcare; 2011.
23. SAS Global Forum. In: Figard S, editor. Paper 284-2009: The basics of experimental design for multivariate analysis. Abbott Park: Abbott Laboratories; 2009.
24. ISPE Product Quality Lifecycle Implementation (PQLI) Guide: Overview of product design, development and realization: a science- and risk-based approach to implementation. http://www.ispe.org/index.php/ci-id/38143/la-id/1.htm.
25. Garcia T, Cook G, Nosal R. PQLI key topics - criticality, design space, and control strategy. J Pharm Innov. 2008;3:60-8.
26. Michaels JN, Bonsignore H, Hudson-Curtis BL, Laurenz S, Lin H-RH, Mathai T, et al. Attribute-based design space: material-science-based quality-by-design for operational flexibility and process portability. J Pharm Innov. 2011;6:193-201.
27. Colgan ST, Watson TJ, Nosal R, Cunningham E. Leveraging API product knowledge and process understanding for successful development and commercialization. AAPS Annual Meeting. 2009.
28. 21 CFR 314.50 (d) (1)(ii)(a). http://www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfcfr/CFRSearch.cfm?fr=314.50.
29. Pharmaceutical cGMPs for the 21st Century - A risk-based approach: second progress report and implementation plan. http://www.fda.gov/Drugs/ DevelopmentApprovalProcess/Manufacturing/ QuestionsandAnswersonCurrentGoodManufacturingPracticescGMPforDrugs/UCM071836.
30. Guidance for Industry: Extended release oral dosage forms: development, evaluation, and application of in vitro/in vivo correlations. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM070239.pdf.
31. USP 34 General Chapter 〈1088〉 In vitro and in vivo evaluation of dosage forms. 2011.
32. Guidance for Industry: Immediate release solid oral dosage forms scale-up and postapproval changes: chemistry, manufacturing, and controls, in vitro dissolution testing, and in vivo bioequivalence documentation. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM070636.pdf.
33. Guidance for Industry: SUPAC-MR: modified release solid oral dosage forms scale-up and postapproval changes: chemistry, manufacturing, and controls; in vitro dissolution testing and in vivo bioequivalence documentation. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM070640.pdf.
34. 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.
35. Guidance for Industry: process validation: general principles and practices. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM070336.pdf.
36. Process analytical technology - particle sciences technical brief 2012: volume 7. http://www.particlesciences.com/news/technicalbriefs/2012/process- analytical-technology.html.
37. CFR 210.3. http://www.gpo.gov/fdsys/pkg/CFR-2011-title21-vol4/pdf/CFR- 2011-title21-vol4-sec210-3.pdf.