APIs: Current trends

Pharmaceutical Engineering

Volumn 23, Issue 3, 2003, Pages 112-124

  Hall, Stephen ^a   Stoker, Andy ^a  

^a AMEC FOSTER WHEELER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG MANUFACTURE; HEAT TRANSFER; MATERIALS MANAGEMENT; PHARMACEUTICAL ENGINEERING; REACTOR; REVIEW; SAFETY;

EID: 0037668822     PISSN: 02738139     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (16)

1. Personal communication with Don Hall, Engineered Technology Corporation, Providence, Rhode Island.
2. Battrum, Mike, Dr., BASF plc, Presentation to IChemE, Newcastle, UK, November 2002.
3. Yue, Changjun, "Comparative Advantage, Exchange Rate, and Exports in China," paper delivered at CERD, conference tilted, "Has China Become a Market Economy?"CERDI, Clermon-Ferrand, France, May 17-18, 2001.
4. Karris, George, "API Manufacturing: How Will Changes in India and China Affect the Outsourcing of APIs,?" Contract Pharma, September 2002.
5. Bureau of Export Administration, Chapter 6, "Toxic Chemicals, Chemical Precursors, and Associated Equipment, Technology and Software," The Foreign Policy Report to Congress, January 18, 2002.
6. Greally, Declan, and Edwards, Roger, "Transferring a Genetically Engineered Biopharmaceutical from Research to Clinical Development - Impact on Facility Design and Build Projects," Pharmaceutical Engineering, 22 (4), July/August 2002, p35-46.
7. BRITEST stands for "Best Route Innovative Technology Evaluation and Selection Techniques," www.britest.co.uk.
8. Personal communication with Professor Paul Sharatt, UMIST.
9. Frost & Sullivan, "European Pharmaceutical Intermediates Market," Report Number B027, November 8, 2002.
10. Rouhi, A. Maureen, "Chiral Roundup," Chemical Engineering News, Volume 80, Number 23, June 10, 2002.
11. Archibald, Thomas, "Safe Reactions," supplement to Chemical Specialties Magazine, October 2001.
12. "Vision 2020:2000 - Separations Roadmap," published by the US Center for Waste Reduction Technologies of the AIChE in cooperation with the US Department of Energy.
13. Commetta, Chiara, et.al., "Active Pharmaceutical Ingredients," published by SRI Consulting, July 2001. http:/ /scup.sric.sri.com/Public/Reports/MEDIC000/.
14. Food and Drug Administration, "Guidance for Industry: Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients," August 2001. Also available from the European Agency for Evaluation of Medicinal Products (EMEA), the International Federation of Pharmaceutical Manufacturers Association (IFPMA), the Pharmaceutical Inspection Convention, and the National Institute of Health Sciences (Japan).
15. ISPE, Baseline®Guide: Volume 1 - Bulk Pharmaceutical Chemicals, First Edition, June 1996. (to be reissued in 2004).
16. Quote from Edwin Rivera Martinez of the FDA's compliance office of the Center for Drug Evaluation and Research, from Synthetic Organic Chemical Manufacturers Association (SOCMA), Current Good Manufacturing Practices Workshop," Washington, D.C., September 23, 2002.