Considerations for Conducting Bioequivalence Studies on Complex Delayed-release, Long Acting Injections and Sustained-release Formulations

Andre Jackson*

Department of Pharmacy, Howard University, USA

*Corresponding Author: Andre Jackson, Department of Pharmacy, Howard University, USA.

Received: February 25, 2022 Published: February 28, 2022

Abstract

Generics have been on the market since the Waxman-Hatch bill was passed in 1984 and the approval process has worked well. However, there are new issues to be resolved. Among these are products with a delayed, sustained, long acting injections or complex absorption. Based upon these absorption issues, how well does adult data predict children. These areas are discussed in the commentary.

Keywords: Injections; Generics; Children/p>

References

1. “What is Hatch-Waxman?”.| PhRMA (2018).
2. “Statistical Approaches to Establishing Bioequivalence”. FDA (2001).
3. Zachary Brennan. “FDA Proposes to Withdraw Two Generic Versions of ADHD Drug Concerta”. RAPS.
4. “Methylphenidate hydrochloride”. (fda.gov).
5. “Methyphenidate Hydrochloride Oral Capsule”. ER (fda.gov).
6. Fang L., et al. “Use of partial area under the curve in bioavailability or bioequivalence assessments: A regulatory perspective”. Clinical Pharmacology and Therapeutics 110 (2021): 880-887.

ef="https://pubmed.ncbi.nlm.nih.gov/28350729/">Krackov R and Rizzolo D. “Real-time ultrasound-guided thoracentesis”. JAAPA4 (2017): 32-37.

Citation

Citation: Andre Jackson. “Considerations for Conducting Bioequivalence Studies on Complex Delayed-release, Long Acting Injections and Sustained-release Formulations". Acta Scientific Pharmacology 3.3 (2022): 57-58.

Copyright

Copyright: © 2022 Andre Jackson. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.