An overview of regulations for bioequivalence assessment of locally acting orally inhaled drug products for the United States, Europe, Canada, and India-Reference-Cited by-同舟云学术

An overview of regulations for bioequivalence assessment of locally acting orally inhaled drug products for the United States, Europe, Canada, and India

Published:2021-12-02 Issue:12 Volume:18 Page:1843-1855
ISSN:1742-5247
Container-title:Expert Opinion on Drug Delivery
language:en
Short-container-title:Expert Opinion on Drug Delivery

Author:

Patil Prajakta P.¹,Pawar Atmaram P.²,Mahadik Kakasaheb R.³,Gaikwad Vinod L.¹⁴

Affiliation:

1. Department of Drug Regulatory Affairs, BVDU Poona College of Pharmacy, Pune, India

2. Department of Pharmaceutics, BVDU Poona College of Pharmacy, Pune, India

3. Department of Pharmaceutical Chemistry, BVDU Poona College of Pharmacy, Pune, India

4. Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER) Hajipur, Bihar, India

Publisher

Informa UK Limited

Subject

Pharmaceutical Science

Link

https://www.tandfonline.com/doi/pdf/10.1080/17425247.2021.2010701

Reference43 articles.

1. 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

2. BMC. Therapeutic equivalence [internet]. Bryn Mawr Commun. LLC. [cited 2021 Aug 21]. Available from: http://bmctoday.net/vehiclesmatter/pdfs/TherapeuticEquivalence.pdf

3. 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

4. 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

5. 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/10.1007/s11095-017-2235–y

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