Response to Comment on “Interchangeability Between Generic and Reference Products: Limits of Average Bioequivalence Methodology”-Reference-Cited by-同舟云学术

Response to Comment on “Interchangeability Between Generic and Reference Products: Limits of Average Bioequivalence Methodology”

Published:2023-01-21 Issue:2 Volume:48 Page:217-219
ISSN:0378-7966
Container-title:European Journal of Drug Metabolism and Pharmacokinetics
language:en
Short-container-title:Eur J Drug Metab Pharmacokinet

Author:

Lechat Philippe^ORCID

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Link

https://link.springer.com/content/pdf/10.1007/s13318-022-00813-5.pdf

Reference13 articles.

1. Nicolas P, Bertagna X. Comment on “Interchangeability between generic and reference products: limits of average bioequivalence methodology”. Eur J Drug Metab Pharmacokinet. 2023. https://doi.org/10.1007/s13318-022-00814-4.

2. Lechat P. Interchangeability between generic and reference products: limits of average bioequivalence methodology. Eur J Drug Metab Pharmacokinet. 2022;47(6):777–87.

3. Chen ML, Rabindra P, Hauck WW, Schuirmann DJ, Hyslop T, Williams R. An individual bioequivalence criterion: regulatory considerations. Stat Med. 2000;19:2821–42.

4. Yu Y, Teerenstra S, Neef C, Burger D, Maliepaard M. A comparison of the intrasubject variation in drug exposure between generic and brand-name drugs: a retrospective analysis of replicate designs. Br J Clin Pharmacol 2015;81:667-78.

5. FDA Draft guidance on Levothyroxin. 2014. https://www.accessdata.fda.gov/drugsatfda_docs/psg/Levothyroxine_Sodium%20capsules_NDA%20021924_RC%20Oct%202018.pdf. Accessed 12 Dec 2022.

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