AbuAsal BS, Hamed SS, Ahmed MA, Al-Mansour L, Uppoor R, Mehta M. Application of Clinical Pharmacology Principles in Drug Development of Modified-Release Products: Leveraging Exposure-Response Information to Support Approval. J Clin Pharmacol. 2020 Nov;60(11):1441-1452. doi: 10.1002/jcph.1637. Epub 2020 May 26. PMID: 32453882.
The development of modified-release (MR) drug products aims to address a clinical need such as improving patient compliance. There are multiple pathways and development strategies for the registration and approval of MR products. The development strategy of an MR product is usually dependent on the availability and pharmacokinetic/pharmacodynamics (PK/PD) characteristics of the reference drug product, that is, an immediate-release (IR) product or a reference MR. Compared with a reference IR product, an MR product is likely to have a different PK profile over the least common dosing time due to unequal dosing intervals. In case of differences in PK profiles between the MR product and the reference product, confirmatory efficacy and safety studies may be needed to support registration.