Bioequivalence for locally acting nasal spray and nasal aerosol products: Standard development and generic approval

AAPS Journal

Volumn 15, Issue 3, 2013, Pages 875-883

  Li, Bing V ^a   Jin, Feiyan ^a   Lee, Sau L ^a   Bai, Tao ^a   Chowdhury, Badrul ^a   Caramenico, Hoainhon T ^a   Conner, Dale P ^a  

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

Author keywords

bioequivalence; generic; locally acting drug; nasal aerosol; nasal spray

Indexed keywords

AZELASTINE; AZELASTINE PLUS FLUTICASONE PROPIONATE; BECLOMETASONE DIPROPIONATE; BUDESONIDE; BUTORPHANOL TARTRATE; CICLESONIDE; CROMOGLYCATE DISODIUM; CYANOCOBALAMIN; DESMOPRESSIN; DESMOPRESSIN ACETATE; DIHYDROERGOTAMINE MESILATE; FENTANYL; FLUNISOLIDE; FLUTICASONE FUROATE; FLUTICASONE PROPIONATE; GENERIC DRUG; IPRATROPIUM BROMIDE; KETOROLAC TROMETAMOL; LONG ACTING DRUG; MOMETASONE FUROATE; NAFARELIN ACETATE; NICOTINE; NOSE SPRAY; OLOPATADINE; SALCATONIN; SUMATRIPTAN SUCCINATE; TETRYZOLINE; TRIAMCINOLONE; TRIAMCINOLONE ACETONIDE;

AEROSOL; ALLERGIC RHINITIS; BIOEQUIVALENCE; BREAKTHROUGH PAIN; CANCER PAIN; CLUSTER HEADACHE; COMMON COLD; CYANOCOBALAMIN DEFICIENCY; DIABETES INSIPIDUS; DRUG ABSORPTION; DRUG EFFICACY; HAY FEVER; HEMOPHILIA A; HUMAN; MIGRAINE WITH AURA; MIGRAINE WITHOUT AURA; NASAL PRURITUS; NOCTURNAL ENURESIS; NOSE ALLERGY; NOSE OBSTRUCTION; NOSE POLYP; PAIN; PARTICLE SIZE; PERENNIAL RHINITIS; PERNICIOUS ANEMIA; POLYDIPSIA; POLYURIA; POSTMENOPAUSE OSTEOPOROSIS; PRECOCIOUS PUBERTY; REVIEW; RHINORRHEA; STANDARD; SUSPENSION; VASOMOTOR RHINITIS; VON WILLEBRAND DISEASE; WITHDRAWAL SYNDROME;

ADMINISTRATION, INTRANASAL; ANIMALS; DRUG APPROVAL; DRUG DISCOVERY; DRUGS, GENERIC; HUMANS; NASAL SPRAYS; THERAPEUTIC EQUIVALENCY;

EID: 84879796178     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-013-9494-2     Document Type: Review

References (9)

1. Pires A et al. Intranasal drug delivery: how, why and what for? J Pharm Pharmaceut Sci. 2009;12(3):288-311.
2. Code of Federal Regulations Title 21, 320.1.
3. FDA. FDA Guidance for industry: bioavailability and bioequivalence studies for nasal aerosols and nasal sprays for local action. April 2003
4. US Food and Drug Administration Advisory Committee for Pharmaceutical Science: Orally Inhaled and Nasal Drug Products. 2001. http://www.fda.gov/ohrms/ dockets/ac/01/slides/3764s1.htm. Accessed 14 Mar 2013
5. FDA. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM319983.pdf. Accessed 14 March 2013
6. FDA. Draft guidance on budesonide inhalation suspension. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ ucm081288.htm. Accessed 26 April 2013
7. Li BV (2009) Introduction to a standardized bioequivalence review procedure for nasal spray products: review template and CTD data summary tables. GPhA/FDA 2009 Fall Technical Conference, October 28, 2009
8. US Food and Drug Administration, Generic Drugs: information for industry public. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ HowDrugsareDevelopedandApproved/ApprovalApplications/ AbbreviatedNewDrugApplicationANDAGenerics/ucm142112.htm. Accessed 14 Mar 2013
9. FDA. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm? fuseaction=Search.DrugDetails. Accessed 14 March 2013