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[e-drug] FDCs for HIV/AIDS, TB and malaria

E-DRUG: FDCs for HIV/AIDS, TB and malaria
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[Fixed-dose combinations were the specific topic of a WHO/EDM consultation
recently in Geneva (15-17 December). Anti-retroviral FDCs are hotly debated
as they might improve adherence (only 1 pill rather than 3) but currently
they are only available from generic companies, and not from big farma. This
poses a dilemma for big donors like USA and the IFPMA.

The papers and presentations have been made available on the Internet - have
a look at:
http://www.who.int/medicines/organization/par/FDC/FDCmain.shtml
Maybe a participant can shed some light on the discussions? WB]

The following papers are downloadable from
www.who.int/medicines/organization/par/FDC/FDCmain.shtml

Monday, 15 December 2003

- Fixed-dose combinations for tuberculosis: lessons learned from a clinical,
production and regulatory perspective (R. Panchagnula)
- Fixed-dose combinations for malaria: translating clinical recommendations
to product supply (Peter Olumese and Andrea Bosman/RBM)
- Fixed-dose combinations for HIV/AIDS: the pros and cons of experiences to
date (Sanjay Pujari)
- Analysis of the impact of introduction on Fixed-dose combinations on
supply management and security when compared with separate dispensing and/or
"co-blistering" (Jane Masiga)
- Review of the evidence on better compliance and treatment outcomes with
Fixed-dose combinations when compared with separate dispensing and/or
"co-blistering" (Jennie Connor)
- Review of the evidence on effect of fixed-dose combinations on the
development of clinical resistance when compared with separate dispensing
and/or "co-blistering"  (Warren Kaplan)
- Field research on packaging, co-blistering; and experiences with other
combinations (Jane Kengeya Kayondo)
- Comparison of the product cost of Fixed-dose combinations in comparison
with separate dispensing and/or "co-blistering" (Robert Bwire, GDF)

Tuesday, 16 December 2003

- Preferred fixed-dose combinations of ARVs for first line use in HIV/AIDS
(Joseph Perriens/Marco Vitoria)
- Clinical perspective from the field on dosing flexibility (Joep Lange)
- Clients perspective on Fixed-dose combinations versus dosing flexibility
- Additional fixed-dose combinations for malaria (Robert Taylor)
- Legal options for overcoming patent barriers of fixed-dose combinations
(Warren Kaplan)
- Summary of Gates Foundation Supported Meeting on FDC Products, Washington
DC, December 12th 2002, Panel Presentation
- Country level experiences (Hanne Bak Pedersen, UNICEF)
- MSF experiences in procuring FDCs (Bernard Pécoul)

Wednesday 17 December 2003

- Development of Fixed-dose combinations; pharmaceutical considerations
(Susan Walters)
- Product formulation of Fixed-dose combinations; practical experiences
(Vinod Arora)
- Assessment Experiences with fixed-dose combinations (ARVs and
Tuberculosis) (János Pogány)
- The WHO Prequalification Scheme  (Lembit Rägo)
- When are new clinical trials needed (Leonard Sachs, Food and Drug
Administration)
- What comparator products should be used for bioequivalence (Roger
Williams, United States Pharmacopeia)

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