التفاصيل البيبلوغرافية
| العنوان: |
Vitamin D3: Summary Report |
| المؤلفون: |
Gianturco, Stephanie L., Pavlech, Laura L., Storm, Kathena D., Yuen, Melissa V., Mattingly, Ashlee N. |
| سنة النشر: |
2021 |
| المجموعة: |
UMB Digital Archive (University of Maryland, Baltimore) |
| مصطلحات موضوعية: |
Vitamin D3, Compounding, Food, Drug and Cosmetic Act, Section 503B, Food and Drug Administration, Outsourcing facility, Cholecalciferol, Drug Compounding, Legislation, Drug, United States Food and Drug Administration |
| الوصف: |
The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), in collaboration with the Food and Drug Administration (FDA), conducted research and outreach to solicit input from the public, including medical specialists, to better understand the use of certain bulk drug substances nominated for use in compounding by outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (the Act). In particular, we were interested in how drugs compounded with these bulk drug substances were used historically, and how they are currently used in clinical practice. The research will assist the FDA in its development of a list of bulk drug substances that outsourcing facilities can use in compounding under section 503B of the Act. Research for each bulk drug substance included a systematic literature review, interviews with medical experts and a survey of healthcare practitioners. Our findings for the nominated substance, Vitamin D3, were summarized in this report. ; U.S. Food and Drug Administration clinical use of bulk drug substances nominated for inclusion on the 503B Bulks List Grant number: #U01FD005946 |
| نوع الوثيقة: |
report |
| اللغة: |
English |
| Relation: |
http://hdl.handle.net/10713/17718; No |
| الاتاحة: |
http://hdl.handle.net/10713/17718 |
| Rights: |
Attribution-NoDerivatives 4.0 International ; http://creativecommons.org/licenses/by-nd/4.0/ |
| رقم الانضمام: |
edsbas.C1ACA06A |
| قاعدة البيانات: |
BASE |