Fixed-Dose Combinations for HIV/AIDS, Tuberculosis, and Malaria - Report of a Meeting Held 16-18 December 2003 Geneva: Fixed-dose combinations for tuberculosis: lessons learned from a clinical, formulation and regulatory perspective

Fixed-Dose Combinations for HIV/AIDS, Tuberculosis, and Malaria - Report of a Meeting Held 16-18 December 2003 Geneva
(2003; 199 pages)

Índice de contenido

	Summary: Observations and some ways forward
		A. Overall observations
		B. Experiences with fixed-dose combinations
		C. Public health priorities
		D. IP and legal options
		E. Pharmaceutical development, quality assurance, and regulatory requirements
	Welcome
		Objectives of the meeting
		Expected outcomes
		Presentations on TB FDC issues
		Presentations and discussions on malaria FDC issues
		Presentations and discussions concerning ARV FDCs
		Presentation and discussion of cross-cutting issues related to logistics, adherence and resistance with FDCs
		Procurement experiences
		Intellectual property and industry issues
		Regulatory issues
		Concluding session
	Fixed-dose combinations for tuberculosis: lessons learned from a clinical, formulation and regulatory perspective
		Abstract
		Tuberculosis in the world of today
		Combination therapy and fixed-dose combination (FDC) formulations in the management of TB
		Registration requirements for rifampicin-containing FDC formulations
		Conclusions
		Acknowledgments
		Annex: Bioavailability of rifampicin, the Biopharmaceutic Classification System and the 4D approach to disease management
		Results/c results/comments
		References
	Product costs of fixed-dose combination tablets in comparison with separate dispensing and or co-blistering of antituberculosis drugs
		Introduction
		Method
		Results
		Discussion
		References
	Fixed-dose combinations: artemisinin-based combination therapies for malaria treatment
		Introduction
		Background
		Implementation issues
		Process leading to the development of guidelines on the use of artemisinin-based combination therapies (ACTs)
		Support to countries in the implementation of ACTs
		Challenges/way forward
		Recommendations for further research
		Conclusion
		References
	Developing combinations of drugs for malaria examination of critical issues and lessons learnt
		Background
		Parasite resistance to antimalarial drugs: a major impediment to effective control
		Strategies to overcome resistance
		Evidence - the key to sensible recommendations
		Further work on the artemisinins
		Recommendations & outstanding challenges
		References
	Safety and long-term effectiveness of generic fixed-dose formulations of nevirapine-based HAART amongst antiretroviral-naïve HIV-infected patients in India
		Abstract
		Introduction
		Methods
		Results
		Discussion
		Immunological improvement
		Viral load
		Clinical findings
		Conclusions
		References
	Effect of introduction of fixed-dose combinations on the drug supply chain: experiences from the field
		Abstract
		Introduction
		Procurement
		Distribution
		Prescribing
		Dispensing to patients
		Cost to patient
		Patient use
		Consumption data
		Conclusion
		References
	Effect of fixed-dose combination (FDC) medications on adherence and treatment outcomes
		Introduction
		Evidence of effect of FDCs or unit-of-use packaging on adherence and treatment outcomes
		Research needs
		Conclusion
		Acknowledgements
		References
	Effect of fixed-dose combination (FDC) drugs on development of clinical antimicrobial resistance: a review paper
		Executive summary
		Introduction
		Biological basis for drug resistance to anti-TB, HIV/AIDS and malaria drugs
		Combination drugs in the context of AMR
		Overcoming clinical resistance using combinations: what is the evidenceⁱ?
		Future research needs
		Conclusion
		Selected studies comparing combinations, FDCs, blister packs and monotherapy with regard to development of antimicrobial resistance
		References
	Fixed-dose combination (FDC) drugs availability and use as a global public health necessity: intellectual property and other legal issues
		Executive summary
		Introduction
		IPRs and Fixed-dose Combinations: Introduction to the “Anticommons Problem”
		IPRs and Fixed-dose Combinations: The “Anticommons Problem” (II)
		Overcoming IP/Legal barriers
		Back to the Future: TRIPS, Public Health, Access to Medicines
		Recommendations
		Conclusions
		References
	Pharmaceutical development and quality assurance of FDCs
		Abstract
		Introduction
		Preformulation studies
		Some examples of the relevance of the properties of the API to product formulation!
		Good Manufacturing Practice (GMP)
		Issues that may arise in the formulation of FDCs that do not arise for single entity products include:
		Changes to registered products (variations)
		Quality control of FDCs
		Recommendations
		References
	Annotated agenda
	List of participants

Fixed-dose combinations for tuberculosis: lessons learned from a clinical, formulation and regulatory perspective

Ramesh Panchagnula^1*, Shrutidevi
Agrawal¹, Yasvant Ashokraj¹,
Manthena Varma¹, Khandavilli
Sateesh¹, Vivekanand Bhardwaj¹,
Sonia Bedi¹, Inder Gulati¹, Jitendra
Parmar¹, Chaman Lal Kaul¹, Bjorn
Blomberg², Bernard Fourie³, Giorgio
Roscigno⁴, Robert Wire⁵, Richard
Laing⁶, Peter Evans⁷and
Thomas Moore⁸

1 Department of Pharmaceutics

National Institute of Pharmaceutical Education and Research (NIPER) Sector-67, SAS Nagar-160 062 (Punjab), India.

2 Department of Medicine/Centre for International Health Haukeland University Hospital, 5021 Bergen, Norway.

3 Director, Lead Programme for Tuberculosis Research Medical Research Council, Private Bag X385, Pretoria 0001, South Africa.

4 Executive Director, Foundation for Innovative New Diagnostics 71Avenue Louis Casai, P.O. Box 93, CH-1218, Geneva, Switzerland.

5 Berkenboog 24, 5386 GC Geffen, The Netherlands.

6 Essential Drugs and Medicines Policy, World Health Organization CH-1211 Geneva 27, Switzerland.

7 Global Drug Facility, StopTB Secretariat, World Health Organization CH-1211 Geneva 27, Switzerland.

8 Principal Program Associate, Management Sciences for Health, Washington, USA.

* Address for correspondence

Prof. Ramesh Panchagnula, Ph.D. FRSC, Head, Department of
Pharmaceutics
National Institute of Pharmaceutical Education and Research (NIPER)
Sector-67, SAS Nagar-160 062 (Punjab), India.
e-mail Drameshp@niper.ac.in