iBCS: 1. Principles and Framework of an Inhalation-Based Biopharmaceutics Classification System-Reference-Cited by-同舟云学术

iBCS: 1. Principles and Framework of an Inhalation-Based Biopharmaceutics Classification System

Published:2022-05-16 Issue:7 Volume:19 Page:2032-2039
ISSN:1543-8384
Container-title:Molecular Pharmaceutics
language:en
Short-container-title:Mol. Pharmaceutics

Author:

Hastedt Jayne E.¹^ORCID,Bäckman Per²^ORCID,Cabal Antonio³,Clark Andy⁴,Ehrhardt Carsten⁵,Forbes Ben⁶^ORCID,Hickey Anthony J.⁷,Hochhaus Guenther⁸,Jiang Wenlei⁹,Kassinos Stavros¹⁰,Kuehl Philip J.¹¹^ORCID,Prime David¹²,Son Yoen-Ju¹³,Teague Simon¹⁴,Tehler Ulrika¹⁵,Wylie Jennifer¹⁶

Affiliation:

1. JDP Pharma Consulting, San Carlos, California 94070, United States

2. Emmace Consulting, Lund, SE-223 81, Sweden

3. Eisai, Woodcliff Lake, New Jersey 07677, United States

4. Aerogen Pharma, San Mateo, California 94402, United States

5. Trinity College Dublin, Dublin 2, Ireland

6. King’s College London, London WC2R 2LS, United Kingdom

7. University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599, United States

8. University of Florida, Gainesville, Florida 32611, United States

9. U.S. FDA, Center for Drug Evaluation and Research, Office of Generic Drugs, Office of Research and Standards, Silver Spring, Maryland 20993, United States

10. University of Cyprus, Nicosia 1678, Cyprus

11. Lovelace Biomedical, Albuquerque, New Mexico 87108, United States

12. Pulmonary Drug Delivery Consultant, Ware SG12, United Kingdom

13. Genentech, South San Francisco, California 94080, United States

14. GlaxoSmithKline, Stevenage SG1 2NY, United Kingdom

15. Pharmaceutical Sciences, R&D, AstraZeneca, Gothenburg 43183, Sweden

16. Merck & Co., Rahway, New Jersey 07033, United States

Funder

Enterprise Ireland

European Cooperation in Science and Technology

Product Quality Research Institute

Publisher

American Chemical Society (ACS)

Subject

Drug Discovery,Pharmaceutical Science,Molecular Medicine

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.molpharmaceut.2c00113

Reference46 articles.

1. Scope and relevance of a pulmonary biopharmaceutical classification system AAPS/FDA/USP Workshop March 16-17th, 2015 in Baltimore, MD

2. ICH M9 on Biopharmaceutics Classification System Based Biowaivers. 2020, ICH M9 https://www.ema.europa.eu/en/documents/scientific-guideline/ich-m9-biopharmaceutics-classification-system-based-biowaivers-step-5_en.pdf, accessed 18 Apr 2022.

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