Dear Laurance,
Greetings from coastal Suffolk. Hope you find the following of some
interest/?use regarding your above posting.
Pignatti F, Aronsson B, Gate N, Vamvakas S, Wade G, Moulon I, Le Courtois P.
The review of drug applications submitted to the European Medicines
Evaluation Agency: frequently raised objections, and outcome. Eur J Clin
Pharmacol 2002 Dec;58(9):573-80.
(This study’s conclusions: Despite the existence of various mechanisms that
allow important deficiencies to be resolved, failure to establish clinical
efficacy due to the lack of adequate randomised controlled trials remained
problematic, leading to a high risk of rejection).
Lexchin J. New drugs with novel therapeutic characteristics. Have they been
subject to randomized controlled trials? Can Fam Physician 2002
Sep;48:1487-92
Rawlins MD, Jefferys DB. Study of United Kingdom product licence
applications containing new active substances, 1987-9. BMJ 1991 Jan
26;302(6770):223-5
Jefferys DB, Leakey D, Lewis JA, Payne S, Rawlins MD. New active substances
authorized in the United Kingdom between 1972 and 1994. Br J Clin Pharmacol
1998 Feb;45(2):151-6
Rawlins MD, Jefferys DB. United Kingdom Product Licence applications
involving new active substances, 1987-1989: their fate after appeals. Br J
Clin Pharmacol 1993 Jun;35(6):599-602
Kobayashi K, DeLap RJ. FDA review practices and priorities for drugs used in
cancer treatment. Ann N Y Acad Sci 2001 Dec;949:341-4.
WWW sorces:
http://www.bioindex.com/Online/BioIndex/biotech.asp
Cheers & regards,
Badri
Dr.P.Badrinath M.D,M.Phil,(Epid)PhD(Cantab),MPH(Distinc)DFPHM
Specialist Registrar in Public Health Medicine,
Suffolk Public Health Network & Coastal PCT, PO Box 170,
St.Clement's Hospital, Ipswich IP3 8LS, UK.
http://myprofile.cos.com/badrishanthi
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