Author:
Gad Shayne C.,Spainhour Charles B.,Serota David G.
Publisher
Springer International Publishing
Reference21 articles.
1. Biomarkers Definitions Working Group. (2001). Biomarkers and surrogate endpoints: Preferred definitions and conceptual frameworks. Clinical Pharmacology and Therapeutics, 69, 89–95.
2. Eikelbom, J. W., Mehta, S. R., Pogue, J., & Yusuf, S. (2001). Safety outcomes in meta-analyses of phase II versus phase III randomized trials. JAMA, 285, 444–450.
3. Gad, S. C. (2009). Clinical trials handbook. Hoboken, NJ: Wiley Interscience.
4. Gad, S. C. (2016). Drug safety evaluation (3rd ed.). New York: Wiley.
5. Gad, S. C. (2010). International regulatory safety evaluation of pharmaceuticals and medical devices. Berlin: Springer.