How Much Nonclinical Safety Data Are Required for a Clinical Study in Ophthalmology?
Author:
Affiliation:
1. PharmaLogic Development, Inc., San Rafael, California.
2. Departments of Pharmacology and Ophthalmology, University of California Davis School of Medicine, Davis, California.
3. M/P Biomedical Consultants LLC, Mill Valley, California.
Publisher
Mary Ann Liebert Inc
Subject
Pharmacology (medical),Pharmacology,Ophthalmology
Link
http://www.liebertpub.com/doi/pdf/10.1089/jop.2015.0120
Reference5 articles.
1. Safety Evaluation of Ocular Drug Delivery Formulations: Techniques and Practical Considerations
2. Translating Drugs From Animals to Humans: Do We Need to Prove Efficacy?
3. The “In-between” New Drug Application
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