“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.)