S. Miksinski

发表

U.S. Food and Drug Administration Approval: Vismodegib for Recurrent, Locally Advanced, or Metastatic Basal Cell Carcinoma

P. Keegan, R. Pazdur, A. Russell, 2013, Clinical Cancer Research.

FDA Approval Summary: Vemurafenib for Treatment of Unresectable or Metastatic Melanoma with the BRAFV600E Mutation

Justin C. Earp, Amy McKee, R. Pazdur, 2014, Clinical Cancer Research.

FDA Approval: Ado-Trastuzumab Emtansine for the Treatment of Patients with HER2-Positive Metastatic Breast Cancer

S. J. Schrieber, R. Pazdur, A. Russell, 2014, Clinical Cancer Research.

Examining Manufacturing Readiness for Breakthrough Drug Development

Earl Dye, Annie Sturgess, Gargi Maheshwari, 2016, AAPS PharmSciTech.

Vandetanib for the Treatment of Symptomatic or Progressive Medullary Thyroid Cancer in Patients with Unresectable Locally Advanced or Metastatic Disease: U.S. Food and Drug Administration Drug Approval Summary

C. Garnett, R. Pazdur, Y. Moon, 2012, Clinical Cancer Research.

Examining Manufacturing Readiness for Breakthrough Drug Development

John G. Groskoph, Kimberly M. L. May, G. Maheshwari, 2016, AAPS PharmSciTech.

Regulatory Perspectives on Strength-Dependent Dissolution Profiles and Biowaiver Approaches for Immediate Release (IR) Oral Tablets in New Drug Applications

J. Duan, T. Ghosh, Zongming Gao, 2016, The AAPS Journal.

U.S. Food and Drug Administration Approval: Vismodegib for Recurrent, Locally Advanced, or Metastatic Basal Cell Carcinoma

P. Keegan, R. Pazdur, A. Russell, 2013, Clinical Cancer Research.

Scientific and Regulatory Considerations in Solid Oral Modified Release Drug Product Development

Susan Rosencrance, Paul Seo, Min Li, 2016, The AAPS Journal.