Abstract
This chapter details the requirements of the U.S. Food and Drug Administration pertaining to suspension drug products. Extensive information is provided on nomenclature, regulatory filing requirements for new drug applications and abbreviated new drug applications, as well as postapproval changes and supplements. The global move to the common technical document format is also discussed. Finally, the authors present an overview of how quality by design principles can be effectively applied to suspension drug product technology.
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Notes
- 1.
CDER Data Standards Manual Drug Nomenclature Monographs for Dosage Form http://www.fda.gov/cder/dsm/DRG/drg00201.htm.
- 2.
Pharmaceutical cGMPs for the twenty-first Century – A Risk-Based Approach. Final Report – Fall 2004 http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm.
References
CFR211. Current Good Manufacturing Practice for Finished Pharmaceuticals. http://www.gpoaccess.gov/cfr/
CFR314.50. Applications for FDA Approval to Market a New Drug. http://www.gpoaccess.gov/cfr/
Annex to Q8: Pharmaceutical Development. http://www.ich.org
CDER Data Standards Manual. http://www.fda.gov/cder/dsm/
Draft Guidance for Industry: Comparability Protocols – Chemistry, Manufacturing, and Controls Information. http://www.fda.gov/cder/guidance/5427dft.pdf
Electronic Orange Book. http://www.fda.gov/cder/ob/default.htm
EMEA Human Medicines – Procedural timetables/Submission dates. http://www.emea.europa.eu/htms/human/submission/submission.htm
European Medicines Agency. http://www.emea.europa.eu
FDA CDER. http://www.fda.gov/cder/
FDA Guidance Documents: Labeling. http://www.fda.gov/cder/guidance/index.htm#Labeling
Federal Food, Drug, and Cosmetic Act. United States Code (U.S.C.) Title 21, Chapter 9. http://www.access.gpo.gov/uscode/title21/chapter9_.html
Guidance for Industry: Changes to an Approved NDA or ANDA. http://www.fda.gov/cder/guidance/3516fnl.pdf
Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies. http://www.fda.gov/cder/guidance/7086fnl.htm
Guidance for Industry: Individual Product Bioequivalence Recommendations. http://www.fda.gov/cder/guidance/bioequivalence/
Guide to Inspections of Dosage Form Drug Manufacturer’s – CGMPR’S. http://www.fda.gov/ora/inspect_ref/igs/dose.html
Guide to Inspections Oral Solutions and Suspensions. http://www.fda.gov/ora/inspect_ref/igs/oral.html
ICH Q8: Pharmaceutical Development. http://www.ich.org.
ICH Q9: Quality Risk Management. http://www.ich.org.
ICH Q10: Pharmaceutical Quality System. http://www.ich.org
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. http://www.ich.org
New Drug Application. http://www.fda.gov/cder/handbook/ndabox.htm
Office of Generic Drugs. http://www.fda.gov/cder/ogd/
Office of Nonprescription Products. http://www.fda.gov/cder/offices/otc/default.htm
Suspensions. United States Pharmacopeia 30 – National Formulary 25 Supplement 2. http://www.uspnf.com
U.S. Food and Drug Administration. http://www.fda.gov
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Gupta, A., Sayeed, V.A., Khan, M.A. (2010). The Science and Regulatory Perspectives of Pharmaceutical Suspensions. In: Kulshreshtha, A., Singh, O., Wall, G. (eds) Pharmaceutical Suspensions. Springer, New York, NY. https://doi.org/10.1007/978-1-4419-1087-5_9
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