A Systematic Assessment of US Food and Drug Administration Dosing Recommendations For Drug Development Programs Amenable to Response-Guided Titration
| Autor: | Kimberly Maxfield, Robert N. Schuck, Issam Zineh, Rajanikanth Madabushi, Lingshan Wang, Daphne Guinn |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Drug
medicine.medical_specialty Individualized dosing media_common.quotation_subject 030226 pharmacology & pharmacy Article Food and drug administration 03 medical and health sciences 0302 clinical medicine Drug Development medicine Humans Pharmacology (medical) Drug Dosage Calculations Dosing Precision Medicine Intensive care medicine Drug Approval media_common Drug Labeling Pharmacology business.industry United States Food and Drug Administration United States Drug development Pharmaceutical Preparations Research Design 030220 oncology & carcinogenesis business Dose selection |
| Zdroj: | Clin Pharmacol Ther |
| Popis: | A key goal in drug development is optimized dosing for patients. Interactions between drug developers and regulatory scientists throughout development are important for the optimization of dosing and serve as a forum to discuss approaches for optimal dosing such as precision or individualized dosing. To date, there has not been a systematic assessment of the advice provided by the US Food and Drug Administration (FDA) to drug developers from an individualized dosing perspective. Here, we reviewed FDA recommendations on dose selection for efficacy trials at End-of-Phase (EOP) meetings between the FDA and drug developers for 76 New Molecular Entities (NMEs) approved between 2013–2017 that are considered amenable for an individualized dosing method, response-guided titration (RGT). Forty FDA dosing recommendations were identified as specific to dose selection and design of the respective efficacy trials and subsequently: 1) characterized based on if they were supportive of individualized dosing and 2) compared with dosing regimens used in efficacy trials and labeling at approval to evaluate if FDA recommendations were implemented. Of these 40 recommendations for efficacy trials, 35 (88%) were considered supportive of individualized dosing. Eighteen of these 40 recommendations (45%) were incorporated into efficacy trials and 11 (28%) were incorporated into labeling. This research suggests that early FDA-sponsor interactions can support the study of doses in efficacy trials that may lead to individualized dosing strategies in labeling. |
| Databáze: | OpenAIRE |
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