Fixed-Dose Combinations for HIV/AIDS, Tuberculosis, and Malaria - Report of a Meeting Held 16-18 December 2003 Geneva
(2003; 199 pages) View the PDF document
Table of Contents
Open this folder and view contentsSummary: Observations and some ways forward
Open this folder and view contentsWelcome
Open this folder and view contentsFixed-dose combinations for tuberculosis: lessons learned from a clinical, formulation and regulatory perspective
Open this folder and view contentsProduct costs of fixed-dose combination tablets in comparison with separate dispensing and or co-blistering of antituberculosis drugs
Close this folderFixed-dose combinations: artemisinin-based combination therapies for malaria treatment
View the documentIntroduction
View the documentBackground
View the documentImplementation issues
View the documentProcess leading to the development of guidelines on the use of artemisinin-based combination therapies (ACTs)
View the documentSupport to countries in the implementation of ACTs
View the documentChallenges/way forward
View the documentRecommendations for further research
View the documentConclusion
View the documentReferences
Open this folder and view contentsDeveloping combinations of drugs for malaria examination of critical issues and lessons learnt
Open this folder and view contentsSafety and long-term effectiveness of generic fixed-dose formulations of nevirapine-based HAART amongst antiretroviral-naïve HIV-infected patients in India
Open this folder and view contentsEffect of introduction of fixed-dose combinations on the drug supply chain: experiences from the field
Open this folder and view contentsEffect of fixed-dose combination (FDC) medications on adherence and treatment outcomes
Open this folder and view contentsEffect of fixed-dose combination (FDC) drugs on development of clinical antimicrobial resistance: a review paper
Open this folder and view contentsFixed-dose combination (FDC) drugs availability and use as a global public health necessity: intellectual property and other legal issues
Open this folder and view contentsPharmaceutical development and quality assurance of FDCs
View the documentAnnotated agenda
View the documentList of participants
 

Challenges/way forward

1. RBM partners plan to create a forum for dialogue with the manufacturers of ACTs. Such a forum is key in facilitating the sharing of information on needs and capacities as well as bottlenecks in ensuring access to these vital products.

2. WHO should coordinate the forecasting of needs for ACTs, due to the implications for manufacturers in sourcing APIs and requirements for raw materials to be extracted from natural sources, linked with agricultural production plans.

3. Manufacturers of ACTs should be encouraged to extend their stability testing protocols to include evaluation of products under tropical conditions (Climatic Zone IV as -described under WHO guidelines for GMP).

4. The pre-qualification of antimalarials should be extended to include the sources of active pharmaceutical ingredients (API) for artemisinin derivatives and their recommended partner drugs.

5. Safety and efficacy data on the WHO recommended ACTs should be collated and disseminated to national regulatory authorities to facilitate the review and registration of these products.

6. Comparator products for bio-equivalence studies with the ACTs should be established. A process for this activity is established in WHO/EDM and funding now needs to be identified.

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Last updated: May 3, 2013