Challenges and strategies to facilitate formulation development of pediatric drug products: Safety qualification of excipients

Author:

Buckley Lorrene A.,Salunke Smita,Thompson Karen,Baer Gerri,Fegley Darren,Turner Mark A.

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference25 articles.

1. Final amended report on the safety assessment of methylparaben, ethylparaben, propylparaben, isopropylparaben, butylparaben, isobutylparaben, and benzylparaben as used in cosmetic products;Anderson;Int. J. Toxicol.,2008

2. Morbidity and mortality among low birth weight infants exposed to an intravenous vitamin E product, E-Ferol;Arrowsmith;Pediatrics,1989

3. Exploring a new approval process for continued excipient innovation;Challener;Pharm. Technol.,2014

4. Reflection Paper: Formulations of Choice for the Paediatric Population;EMA,2005

5. EU Guideline on Pharmaceutical Development of Medicines for Paediatric Use;EMA,2013

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