Fixed-Dose Combinations for HIV/AIDS, Tuberculosis, and Malaria - Report of a Meeting Held 16-18 December 2003 Geneva
(2003; 199 pages) Ver el documento en el formato PDF
Índice de contenido
Abrir esta carpeta y ver su contenidoSummary: Observations and some ways forward
Abrir esta carpeta y ver su contenidoWelcome
Cerrar esta carpetaFixed-dose combinations for tuberculosis: lessons learned from a clinical, formulation and regulatory perspective
Ver el documentoAbstract
Ver el documentoTuberculosis in the world of today
Ver el documentoCombination therapy and fixed-dose combination (FDC) formulations in the management of TB
Ver el documentoRegistration requirements for rifampicin-containing FDC formulations
Ver el documentoConclusions
Ver el documentoAcknowledgments
Ver el documentoAnnex: Bioavailability of rifampicin, the Biopharmaceutic Classification System and the 4D approach to disease management
Ver el documentoResults/c results/comments
Ver el documentoReferences
Abrir esta carpeta y ver su contenidoProduct costs of fixed-dose combination tablets in comparison with separate dispensing and or co-blistering of antituberculosis drugs
Abrir esta carpeta y ver su contenidoFixed-dose combinations: artemisinin-based combination therapies for malaria treatment
Abrir esta carpeta y ver su contenidoDeveloping combinations of drugs for malaria examination of critical issues and lessons learnt
Abrir esta carpeta y ver su contenidoSafety and long-term effectiveness of generic fixed-dose formulations of nevirapine-based HAART amongst antiretroviral-naïve HIV-infected patients in India
Abrir esta carpeta y ver su contenidoEffect of introduction of fixed-dose combinations on the drug supply chain: experiences from the field
Abrir esta carpeta y ver su contenidoEffect of fixed-dose combination (FDC) medications on adherence and treatment outcomes
Abrir esta carpeta y ver su contenidoEffect of fixed-dose combination (FDC) drugs on development of clinical antimicrobial resistance: a review paper
Abrir esta carpeta y ver su contenidoFixed-dose combination (FDC) drugs availability and use as a global public health necessity: intellectual property and other legal issues
Abrir esta carpeta y ver su contenidoPharmaceutical development and quality assurance of FDCs
Ver el documentoAnnotated agenda
Ver el documentoList of participants
 

Abstract

Worldwide, tuberculosis (TB) remains one of the most important communicable diseases in terms of morbidity and mortality. Its control requires multi-drug therapy for at least six months and this tends to lead to patient non-compliance, and thus failure of therapy and ultimately emergence of drug resistance. Anti-TB therapy, given in the form of fixed-dose combinations (FDCs) reduces the number of tablets to be consumed and thereby increases patient compliance with recommended treatment regimens. Thus, FDCs play a significant role in preventing the emergence of drug resistance. However, the quality of FDCs and their registration requirements are major hurdles to their implementation in national programmes. There is also concern about the bioavailability of rifampicin.

To increase use of FDCs, their quality and registration needs to be addressed systematically. It is anticipated that a large global market for FDCs will encourage large-scale production and increased competition, which in turn will result in FDCs at affordable prices. The ‘Global TB Drug Facility’, established by WHO and its Stop TB partners, aims to ensure universal uninterrupted access to quality TB drugs for implementation of directly observed treatment short-course (DOTS) in resource-poor countries. In this programme, four-drug FDCs were accepted as the drugs of first choice because of their obvious advantages in controlling TB.

Current knowledge on anti-TB FDCs, their dosage, combinations, available clinical studies and the experiences with TB therapy should serve as lessons for selection of appropriate FDCs for other diseases such as malaria and AIDS.

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Última actualización: le 3 mayo 2013