Journal article
An Algorithm to Identify Compounded Non-Sterile Products that Can Be Formulated on a Commercial Scale or Imported to Promote Safer Medication Use in Children
Pharmacy, v 3(4)
01 Dec 2015
PMID: 28975916
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
The lack of commercially-available pediatric drug products and dosage forms is well-known. A group of clinicians and scientists with a common interest in pediatric drug development and medicines-use systems developed a practical framework for identifying a list of active pharmaceutical ingredients (APIs) with the greatest market potential for development to use in pediatric patients. Reliable and reproducible evidence-based drug formulations designed for use in pediatric patients are needed vitally, otherwise safe and consistent clinical practices and outcomes assessments will continue to be difficult to ascertain. Identification of a prioritized list of candidate APIs for oral formulation using the described algorithm provides a broader integrated clinical, scientific, regulatory, and market basis to allow for more reliable dosage forms and safer, effective medicines use in children of all ages. Group members derived a list of candidate API molecules by factoring in a number of pharmacotherapeutic, scientific, manufacturing, and regulatory variables into the selection algorithm that were absent in other rubrics. These additions will assist in identifying and categorizing prime API candidates suitable for oral formulation development. Moreover, the developed algorithm aids in prioritizing useful APIs with finished oral liquid dosage forms available from other countries with direct importation opportunities to North America and beyond.
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Details
- Title
- An Algorithm to Identify Compounded Non-Sterile Products that Can Be Formulated on a Commercial Scale or Imported to Promote Safer Medication Use in Children
- Creators
- Varsha Bhatt-Mehta - University of MichiganRobert B. MacArthur - Clinical Development, Pharmaceutics International, Inc., Hunt Valley, MD, 21031, USA.Raimar Loebenberg - Fac Pharm & Pharmaceut Sci, Div Pharmaceut Sci, Edmonton, AB T6G 2R3, CanadaJeffrey J. Cies - Collaborative Research GroupIbolja Cernak - Collaborative Research GroupRichard H. Parrish - Collaborative Research Group
- Publication Details
- Pharmacy, v 3(4)
- Publisher
- Mdpi
- Number of pages
- 11
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- College of Medicine
- Web of Science ID
- WOS:000367727900007
- Other Identifier
- 991019350584704721
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- Collaboration types
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Pharmacology & Pharmacy