Little progress has been made since the 1960s and 1970s to widen the therapeutic arsenal against Trypanosoma cruzi, the causative pathogen of Chagas disease, which remains a frustrating and perplexing infectious disease. This chapter focuses on the strategic and operational challenges in the clinica...l drug development of a novel antitrypanosomal agent for Chagas disease. The various elements that contribute to a robust assessment of treatment effect including dose selection, choice of patient population, trial methodology, endpoint measures, and regulatory perspectives are discussed. The learnings herein should serve as resource to help researchers and other stakeholders optimize their clinical development plans and speed delivery of new medicines to patients with Chagas disease.
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Drug registration in Kenya started in 1982; the process mainly involves an evaluation committee at the Kenya Pharmacy and Poisons Board (PPB) that aims to approve products based on quality, safety and efficacy.
Many vaccines and drugs hold the promise of reducing mortality and morbidity among pregnant women and infants living in low- and middle-income countries (LMICs). However, sufficient information on the safety of drugs and vaccines in pregnant women is rarely available at the time of product licensure... or approval. To account for this, active safety surveillance efforts are needed during the post-licensure and post-approval
phase to assess the safety of drugs and vaccines in pregnant women and their offspring. Pregnancy exposure registries (PER) are used to monitor the safety of vaccines and drugs. PERs are observational studies that systematically collect health information on exposure to medical products such as drugs and vaccines during pregnancy. This review demonstrates that a number of resources presently exist in LMICs that perform active safety surveillance in pregnant populations. These results indicate such systems employ a wide variety of approaches, each with their own set of strengths and challenges, as summarized in the final section of the report.
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Report: A survey conducted among the 27 high MDR-TB burden countries.
March – July 2015
Stop TB Partnership in collaboration with Medecins Sans Frontieres (MSF).
Accessed November 2017.
Three Years After Enactment of the Drug Quality and Security Act
A survival guide for clinicans.
3rd edition.
Irresponsible pharmaceutical companies fuel the proliferation of superbugs through supply chain pollution, the European Public Health Alliance (EPHA) reports. The advocacy group uncovered lapses such as dirty production and inadequate waste disposal in the production of antimicrobials in China and I...ndia, which supplies most of the antimicrobials consumed in Europe. In a briefing detailing the pollution, the EPHA urges major purchasers of antibiotics to blacklist irresponsible pharmaceutical companies, demand that the industry clean up its supply chain, introduce greater transparency on the origin of antibiotics, and review and revise procurement policies from an ethics perspective.
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First Revised Edition
March 2000
The aim of the operational framework is to ensure 1) accurate collection, handling, shipment and storage of specimens collected in countries implementing HIV drug resistance surveillance; and 2) the availability of quality-assured HIV genotyping laboratory services producing comparable and reliable ...results at the national, regional and global levels.
This publication updates the WHO HIVResNet HIV drug resistance laboratory operational framework published in 2017 and reflects technical and strategic developments over the past three years.
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National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
Division of Tuberculosis Elimination
Accessed: 08.10.2019
A new formulation of a drug to prevent excessive bleeding following childbirth could save thousands of women’s lives in low- and lower-middle-income countries, according to a study led by the World Health Organization (WHO) in collaboration with MSD for Mothers and Ferring Pharmaceuticals.
Curren...tly WHO recommends oxytocin as the first-choice drug for preventing excessive bleeding after childbirth. Oxytocin, however, must be stored and transported at 2–8 degrees Celsius, which is hard to do, in many countries, depriving many women of access to this lifesaving drug. When they can obtain it, the drug may be less effective because of heat exposure.
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Guidelines
HIV drug resistance
July 2017
Training for staff working at DR-TB management centres.
Training modules
STATUTORY INSTRUMENTS | SUPPLEMENT No. 8 28th March, 2014 | STATUTORY INSTRUMENTS SUPPLEMENT | to The Uganda Gazette No. 18 Volume CVII dated 28th March, 2014 | Printed by UPPC, Entebbe, by Order of the Government. | STATUTORY INSTRUMENTS | 2014 No. 29.
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention.
Division of Tuberculosis Elimination.