Book chapter: ‘Evaluation of Stability Data’, chapter in “Pharmaceutical Stability Testing”, Springer |
“Analytical
Test Methods for Biological and Biotechnological Products”, N. Ritter and J. McEntire, in Process
Validation in Manufacturing of Biopharmaceuticals: Guidelines,
Current Practices, and Industrial Case Studies (A.S.
Rathore and G. Sofer, eds), CRC Press, Taylor and Francis Group,
Boca Raton, FL, 2005, pp. 227-326. |
"Accelerated
Approval and Tougher Post Marketing Regulations: A Change in
the Playing Field" Journal of GXP Compliance. January
2005 Vol. 3, No. 2 - By Dr. Steve Litwin,
BCG Senior Clinical Consultant |
| FDA
Regulatory Affairs: A Guide for Prescription Drugs, Medical
Devices, and Biologics. Book Chapter on Biologics by Dr. Jim Kenimer, BCG President & Dr. John Jessop, BCG Director of Pharmacology/Toxicology |
| Gene
Transfer for Neurologic Disease: Agencies, Policy, and Process. Article in Neurology (Dec. 2004) by Dr. Andra Miller, BCG Director of Cell & Gene Therapies & Dr. Jerry Mendell |
| "The
IND (Investigational New Drug) Application: Is Our Product Safe
to Administer in the Clinic?" by Dr.
John Jessop, Director, Pharmacology/Toxicology with BCG (First published in GOR Volume 5 No 2 May 2003.
Reproduced by permission of Global Outsourcing Review."
Click on title above to read article.) |
