References
- USFDA. CFR - code of federal regulations title 21CFR314.3 [internet]. USFDA CFR; 2020 [ cited 2021 May 23]. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=314.3
- BMC. Therapeutic equivalence [internet]. Bryn Mawr Commun. LLC. [ cited 2021 Aug 21]. Available from: http://bmctoday.net/vehiclesmatter/pdfs/TherapeuticEquivalence.pdf
- Zerilli T, He A, Nathan JP, et al. To substitute or not to substitute: that is the question [internet]. Pharm. Times; 2011 [ cited 2021 May 23]. Available from: https://www.pharmacytimes.com/view/genericfeature–0311
- USFDA. Orange book: approved drug products with therapeutic equivalence evaluations [internet]. USFDA Orange B; 2021 [ cited 2021 May 23]. Available from: https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
- FYs 2013–2017 regulatory science report: locally-acting orally inhaled and nasal drug products [internet]. US Food Drug Adm; 2018 [ cited 2019 Jul 17]. cited http://link.springer.com/https://doi.org/10.1007/s11095-017-2235–y
- Raines KW. A primer on generic drugs and bioequivalence: an overview of the generic drug approval process [internet]. [ cited 2019 Jul 17]. p. 1–43. Available from: https://www.fda.gov/media/89135/download
- Davit B, Braddy AC, Conner DP, et al. International guidelines for bioequivalence of systemically available orally administered generic drug products: a survey of similarities and differences. AAPS J. 2013;15(4):974–990.
- USFDA. Orange book preface | FDA [internet]. USFDA Orange B. Pref; 2021 [ cited 2021 May 23]. Available from: https://www.fda.gov/drugs/development-approval-process-drugs/orange-book-preface#_ftn9
- Roy J. Drugs, medicines, and regulatory authorities. In: Roy J, editor. An Introd to Pharm Sci. 1st ed. Amsterdam: Elsevier; 2011. p. 43–68.
- Santos-Oliveira R. Pharmaceutical equivalence and bioequivalence of radiopharmaceuticals: thinking the possibility of generic radiopharmaceuticals and preparing for new technology as nanotechnology drugs. J Bioequivalence Bioavailability. 2014;6:23.
- Bermingham E, Del Castillo JR, Lainesse C, et al. Demonstrating bioequivalence using clinical endpoint studies. J Vet Pharmacol Ther. 2012;35:31–37.
- Dunne S, Shannon B, Dunne C, et al. A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study. BMC Pharmacol Toxicol. 2013;14(1):1. BioMed Central.
- EMA. Guideline on the investigation of bioequivalence [internet]. 1997 [ cited 2019 Jul 17]. Available from: http://www.ema.europa.eu
- CADTH. What are bioavailability and bioequivalence [internet]. 2012 [ cited 2019 Jul 17]. p. 1–3. Available from: http://www.pharmac.govt.nz/2009/08/25/bpjse_generics_2009.pdf
- CDSCO. BA/ BE [internet]. 2019 [ cited 2019 Jul 17]. Available from: https://cdsco.gov.in/opencms/opencms/en/bioequi_bioavail/
- Lee SL, Adams WP, Li BV, et al. In vitro considerations to support bioequivalence of locally acting drugs in dry powder inhalers for lung diseases. AAPS J. 2009;11(3):414–423.
- Fuglsang A. The US and EU regulatory landscapes for locally acting generic/hybrid inhalation products intended for treatment of asthma and COPD. J Aerosol Med Pulm Drug Deliv. 2012;25(4):243–247.
- Health Canada. Guidance to establish equivalence or relative potency of safety and efficacy of a second entry short-acting beta2-agonist metered dose inhaler (MDI) [internet]. Heal. Canada; 1999 [ cited 2021 Jun 2]. p. 1–33. Available from: https://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/mdi_bad-eng.pdf
- USFDA. Orange book: approved drug products with therapeutic equivalence evaluations [internet]. 2019 [ cited 2019 Jul 17]. Available from: https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
- Peng T, Lin S, Niu B, et al. Influence of physical properties of carrier on the performance of dry powder inhalers. Acta Pharm Sin B. 2016;6(4):308–318.
- CDER FDA. Guidance for industry bioavailability and bioequivalence studies for nasal aerosols and nasal sprays for local action [internet]. US Food Drug Adm; 2003 [ cited 2019 Jul 17]. p. 1–37. Available from: http://www.fda.gov/cder/guidance/index.htm
- USFDA. Draft guidance on Albuterol Sulfate [internet]. USFDA; 2013 [ cited 2021 Jun 2]. p. 1–9. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/psg/Albuterolsulfate_meteredinhalationaerosol_RLD20503;20983;21457_RV12-16.pdf
- USFDA. Draft guidance on Budesonide [internet]. USFDA; 2012 [ cited 2021 Jun 5]. p. 1–15. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/psg/Budesonide_Inhalation_Sus_20929_RC_09-12.pdf
- Lu D, Lee SL, Lionberger RA, et al. International guidelines for bioequivalence of locally acting orally inhaled drug products: similarities and differences. AAPS J. 2015;17(3):546–557.
- Christopher D, Adams WP, Lee DS, et al. Product quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols: part 2–evaluation of a method for determining equivalence. AAPS PharmSciTech. 2007;8(1):E39–E48. Springer.
- Lee S. Scientific and regulatory considerations for bioequivalence (BE) of dry powder inhalers (DPIs) [internet]. US Food Drug Adm; 2011 [ cited 2019 Jul 17]. p. 1–24. Available from: https://www.fda.gov/media/82921/download
- Health Canada. Guidance document: data requirements for safety and effectiveness of subsequent entry inhaled corticosteroid products used for the treatment of asthma [internet]. Heal. Canada; 2018 [ cited 2019 Jul 17]. p. 1–14. Available from: https://www.Canada.ca/en/health-Canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/inhaled-corticosteroid-profile/inhaled-corticosteroid-guidance.html
- Health Canada. Guidance for industry - pharmaceutical quality of inhalation and nasal products [internet]. Heal. Canada; 2006 [ cited 2021 Jun 2]. Available from: https://www.Canada.ca/en/health-Canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/chemical-entity-products-quality/guidance-industry-pharmaceutical-quality-inhalation-nasal-products.html
- USFDA. Draft guidance on Fluticasone Propionate; Salmeterol Xinafoate [internet]. USFDA; 2013 [ cited 2021 Jun 2]. p. 1–7. Available from: https://wayback.archive-it.org/7993/20170406171133/https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM367643.pdf
- EMA. Guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulm [internet]. EMA; 2009 [ cited 2021 Jun 2]. p. 1–26. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-requirements-clinical-documentation-orally-inhaled-products-oip-including-requirements_en.pdf
- EMA. Guideline on the investigation of bioequivalence [internet]. EMA; 2010 [ cited 2021 Jun 2]. p. 1–27. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-bioequivalence-rev1_en.pdf
- Health Canada. Draft guidance document on data requirements for safety and effectiveness of subsequent market entry inhaled corticosteroid products for use in the treatment of asthma [internet]. Heal. Canada; 2011 [ cited 2021 Jun 2]. p. 1–16. Available from: https://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/consultation/drug-medic/draft_inhal_ebauche_corticost-eng.pdf
- CDSCO. A guidance document for medical device [internet]. 2018 [ cited 2018 Jun 30]. Available from: http://www.cdsco.nic.in/writereaddata/GuidanceDocumentipv.pdf
- Lee SL, Saluja B, García-Arieta A, et al. Regulatory considerations for approval of generic inhalation drug products in the US, EU, Brazil, China, and India. AAPS J. 2015;17(5):1285–1304. Springer.
- CDSCO. Guidelines for bioavailability and bioequivalence studies [internet]. 2005 [ cited 2019 Jun 28]. Available from: http://www.cdsco.nic.in/html/beguidelinesdraftver10march16,05.pdf
- CDSCO. The drugs and cosmetics act, 1940 (as amended up to the 30th June, 2005) and The Drugs and Cosmetics Rules, 1945 (as amended up to the 30th June, 2005). 2005.
- Ministry of Health and Family Welfare India. Schedule Y, drugs and cosmetics (IInd amendment) rules, 2005 [internet]. 2005 [ cited 2019 Jul 17]. p. 1–37. Available from: https://ibkp.dbtindia.gov.in/DBT_Content_Test/CMS/Guidelines/20181115121749531_Schedule_Y.pdf
- Good clinical practice guidelines [internet]. [ cited 2019 Jul 17]. Available from: http://unpan1.un.org/intradoc/groups/public/documents/apcity/unpan009867.pdf
- National Institute of Tuberculosis and Respiratory Diseases. Ethical guidelines for biomedical research on human subjects [internet]. [ cited 2019 Jul 17]. Available from: http://www.nitrd.nic.in/WriteReadData/userfiles/file/EthicalGuidelines.pdf
- Hochhaus G, Davis-Cutting C, Oliver M, et al. Current scientific and regulatory approaches for development of orally inhaled and nasal drug products: overview of the IPAC-RS/University of Florida Orlando inhalation conference. AAPS J. 2015;17(5):1305–1311. Springer US.
- García -Arieta A. In vitro and PK studies for generics based on European experience [internet]. IPAC-RS/University Florida Orlando Inhal. Conf. Orlando; 2014 [ cited 2021 Jun 4]. p. 1–44. Available from: https://custom.cvent.com/7BA2EE65E8B64AEBB1E77F19E7FD30BC/files/event/8a749091c2c741228907ca5c70b619eb/f1667a8615fe4a55ad931c409392c08e.pdf
- Santos GML. Considerations for generic OIPs in Brazil [internet]. IPAC-RS Univ. Florida Orlando Inhal. Conf; 2014 [ cited 2021 Jun 4]. Available from: https://custom.cvent.com/7BA2EE65E8B64AEBB1E77F19E7FD30BC/files/event/8a749091c2c741228907ca5c70b619eb/98f6e2e31b024eed9c8f81c31b3e9242.pdf
- CHMP EMEA. Guideline on the pharmaceutical quality of inhalation and nasal products [internet]. EMEA; 2006 [ cited 2021 Aug 18]. p. 1–27. cited https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-pharmaceutical-quality-inhalation-nasal-products_en.pdf