The absence of available pediatric dosage forms can lead to an increased potential for dosing errors or nonadherence. Therefore, specific dosing guidelines and acceptable dosage forms for pediatric patients need to be developed to optimize therapeutic efficacy and limit and prevent serious adverse side effects.
Custom-designed equipment and suites, flexible manufacturing lines, and alternative delivery and manufacturing approaches are critical to achieving a timely launch in a competitive marketplace.
Experts share a case study that illustrates how to use PBPK modeling, the developability classification system, and the biopharmaceutics drug distribution classification system together to facilitate the development of a molecule.
Learn how to avoid common pitfalls in the transfer and scale-up process using an integrated approach, with industry experts sharing key considerations when planning for scale-up of a development program.
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