Drug Development Considerations for Additives to Organ Preservation Solutions.
| Autor: | O'Brien Laramy M; Synthetic Molecule Pharmaceutical Sciences, Genentech, Inc., South San Francisco, CA., Robinson J; Pharma Technical Regulatory, Genentech, Inc., South San Francisco, CA., Venkatramani CJ; Synthetic Molecule Pharmaceutical Sciences, Genentech, Inc., South San Francisco, CA., Horn S; Pharma Technical Regulatory-Device and Combination Products, F. Hoffmann-La Roche Ltd, Basel, Switzerland., Steiner C; Analytical Research & Development, Pharma Technical Development, F. Hoffmann-La Roche, Basel, Switzerland., Son YJ; Pharma Technical Development Project and Portfolio Development, South San Francisco, CA. |
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| Jazyk: | angličtina |
| Zdroj: | Transplantation [Transplantation] 2024 Oct 08. Date of Electronic Publication: 2024 Oct 08. |
| DOI: | 10.1097/TP.0000000000005221 |
| Abstrakt: | The addition of a novel therapeutic agent to an organ preservation solution has the potential to address unmet needs in organ transplantation and enhance outcomes for transplant recipients. However, the development expectations for novel therapeutic agents in this context are unclear because of limited precedence and published regulatory guidance documents. To address these gaps, we have articulated a drug development strategy that leverages expectations for parenteral drug products administered via more conventional routes (eg, intravenous) and provided considerations for when deviations may be justified. We have supplemented this strategy with a comparison to available regulatory guidance from the US Food and Drug Administration to highlight potential areas for further clarification. The strategy articulated here is based on Genentech's internal experience for a program intended for use in kidney transplantation. (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.) |
| Databáze: | MEDLINE |
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