BOOKS
2006 Physicians' Desk Reference (Thomson Healthcare, Montvale, NJ 2006)
Biopharmaceutical Drug Design and Development, S. Wu-Pong and Y. Rojanasakul, Eds. (Humana Press Inc., Totowa, NJ 1999)
W. Bains, Biotechnology from A to Z, 3rd ed. (Oxford University Press, Oxford, UK 2004)
Expediting Drug and Biologics Development: A Strategic Approach, 3rd ed., Steven E. Linberg, Ed. (Parexel International Corporation, Waltham, MA 2006)
FDA-Speak: A Glossary and Agency Guide, 2nd ed. D.E. Snyder, Ed. (CRC Press, Boca Raton, FL 2001)
Handbook of Biopharma Industry Acronyms & Terms, Ronald P. Even, Ed, (Jones and Bartlett Publishers, Sudbury, MA 2009)
J.F. Huxsoll, Quality Assurance for Biopharmaceuticals (John Wiley & Sons, Inc., New York 1994)
J.M. Walker and M. Cox, The Language of Biotechnology: A Dictionary of Terms, 2nd ed. (American Chemical Society, Washington, DC 1995)
The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals,14th Edition (Merck & Co., Inc., Whitehouse Station, NJ, 2006)
The Merck Manual of Medical Information Second Home Edition (Merck & Co., Inc., Whitehouse Station, NJ 2003)
P. Singleton and D. Sainsbury, Dictionary of Microbiology and Molecular Biology, 3rd ed. (John Wiley & Sons, New York 2002)
Process Validation in Manufacturing of Biopharmaceuticals, Anurag S. Rathore and Gail Sofer, Eds. (CRC Press, Taylor & Francis Group, Boca Raton, FL 2005)
J.D. Watson, et al., Recombinant DNA, genes and genomes: a short course. (Scientific American Books, distributed by W.H. Freeman
and Company, New York 2007)
ORGANIZATIONS
American Association of Pharmaceutical Scientists,
Arlington, VA
http://aaps.org/
Biotechnology Industry Organization
Washington, DC;
http://bio.org/
California Separation Science Society
San Francisco, CA
http://casss.org/
FDA
US Food and Drug Administration, Rockville, Maryland
Center for Biologics Evaluation and Research,
http://www.fda.gov/cber/index.html
Center for Drug Evaluation and Research,
http://www.fda.gov/cder/
Electronic Freedom-of-Information Reading Room,
http://www.fda.gov/foi/
Health Canada
Health Products and Food Branch Inspectorate,
Ottawa, ON
hc-sc.gc.ca/
The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use
Geneva, Switzerland
http://ich.org/
International Pharmaceutical Excipient Council of the Americas
Arlington, VA
http://ipecamericas.org/
International Society for Pharmaceutical Engineering
Tampa, FL
http://ispe.org/
National Center for Biotechnology Information
National Library of Medicine
Bethesda, MD
ncbi.nlm.nih.gov/
Parenteral Drug Association
Bethesda, MD
http://pda.org/
