Development of Drug Products: Similarities and Differences Between Protein Biologics and Small Synthetic Molecules

Protein Formulation and Delivery, Second Edition

Volumn , Issue , 2007, Pages 327-334

  McNally, Eugene J ^a   Hastedt, Jayne E ^b  

^a Catalent Pharma Solutions Company   (United States)

^b ALZA CORPORATION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 79955476503     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.3109/9780849379529-17     Document Type: Chapter

References (7)

1. Van Arnum P, Greb E, McCormick D. Pharmaceutical Technology 2005 Manufacturer’s Rankings, July 2006.
2. Carstensen JT. Drug stability: principles and practices. Vol. 43. Drugs and the Pharmaceutical Sciences. New York: Marcel Dekker, 1990:2–4.
3. ICH Harmonized Tripartite Guideline Q8—Pharmaceutical Development, Nov 10, 2005.
4. http://www.gene.com/gene/about/views/followon-biologics.jsp.
5. Markovic I. Challenges associated with extractable and/or leachable substances in therapeutic biologic protein products. Am Pharm Rev 2006; 9:20–27.
6. Modi P, Mihic M, Lewin A. The evolving role of oral insulin in the treatment of diabetes using a novel RapidMist System. Diabetes Metab Res Rev 2002; 18 (suppl 1): S38–S42.
7. Pearlman R, Nyugen T. Pharmaceutics of protein drugs. J Pharm Pharmacol 1992; 44:178–185.