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Bioequivalence studies of reformulated pharmaceuticals newly off patent Cover

Bioequivalence studies of reformulated pharmaceuticals newly off patent

Open Access
|Feb 2017

References

  1. 1. Chen, ML, Shah V, Patnaik R, Adams W, Hussain A, Conner D, et al. Bioavailability and bioequivalence: an FDA regulatory overview. Pharm Res. 2001; 18: 1645-50.10.1023/A:1013319408893
  2. 2. Raw AS, Furness MS, Gill DS, Adams RC, Holcombe FO, Yu LX. Regulatory considerations of pharmaceutical solid polymorphism in Abbreviated New Drug Applications (ANDAs). Adv Drug Deliv Rev. 2004; 56:397-414.10.1016/j.addr.2003.10.01114962589
  3. 3. WHO Tech Rep Ser. Additional guidelines for organizations performing in vivo bioequivalence studies. Geneva 2006.
  4. 4. Jullangkoon, M, Jarurathanasirikul S, Ainlang N. Bioequivalence study of cefepime intramuscular injection in healthy volunteers. Asian Biomed. 2014; 8: 237-4010.5372/1905-7415.0802.284
DOI: https://doi.org/10.5372/1905-7415.0801.273 | Journal eISSN: 1875-855X | Journal ISSN: 1905-7415
Language: English
Page range: 137 - 138
Published on: Feb 4, 2017
Published by: Chulalongkorn University
In partnership with: Paradigm Publishing Services
Publication frequency: 6 issues per year

© 2017 Editorial Office of Asian Biomedicine, published by Chulalongkorn University
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.