Position Statement On Innovative Clinical Trial Design For Development Of New Tb Treatments

Author :
Publisher : World Health Organization
ISBN 13 : 9240030808
Total Pages : 14 pages
Book Rating : 4.00/5 ( download)

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Download or read book Position statement on innovative clinical trial design for development of new TB treatments written by and published by World Health Organization. This book was released on 2021-07-14 with total page 14 pages. Available in PDF, EPUB and Kindle. Book excerpt: This position statement aims to support TB regimen development by highlighting key clinical trial characteristics to help advance novel therapies. It summarises key innovations in TB clinical trial designs, ranging from pharmacokinetic-pharmacodynamic (PK-PD) modelling and new advances in biomarker development to the value of novel clinical trial design methodologies and post-licensure observational studies. For various stages along the development pathway, outstanding challenges are described alongside possible solutions to help overcome these issues. Beyond a welcome expansion of the TB drug pipeline, innovations in TB drug development and clinical trial design are anticipated to accelerate the development and evaluation as well as facilitate approval of novel regimens to treat all forms of TB.

Author :
Publisher : World Health Organization
ISBN 13 : 9240030867
Total Pages : 87 pages
Book Rating : 4.62/5 ( download)

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Download or read book Report of the technical consultation on innovative clinical trial designs for development of new TB treatments written by and published by World Health Organization. This book was released on 2021-07-28 with total page 87 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Global Tuberculosis Programme of the World Health Organization (WHO) convened a virtual technical consultation on “Innovative Clinical Trial Designs for Development of New TB Treatments” on 5 days between 20 August and 13 October 2021. The main objective of the meeting was to establish evidence-based approaches to trial designs and use of data to inform policy guidance of new regimens for the treatment of TB with the view to accelerate future regimen development. The consultation brought together researchers, academics, technical partners, TB drugs and regimens developers including pharmaceutical industry, trialists, regulators, guideline developers, programme managers, nongovernmental organizations and civil society.

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309158060
Total Pages : 442 pages
Book Rating : 4.60/5 ( download)

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Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Author :
Publisher : World Health Organization
ISBN 13 : 9240047158
Total Pages : 59 pages
Book Rating : 4.50/5 ( download)

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Download or read book Report of the technical consultation on innovative clinical trial designs for evaluating new TB preventive treatments written by and published by World Health Organization. This book was released on 2022-04-19 with total page 59 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Zeeshan Fatima
Publisher : Academic Press
ISBN 13 : 0323919448
Total Pages : 316 pages
Book Rating : 4.49/5 ( download)

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Download or read book Biology of Mycobacterial Lipids written by Zeeshan Fatima and published by Academic Press. This book was released on 2022-06-03 with total page 316 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biology of Mycobacterial Lipids covers various topics pertaining to the advancements and current research in the field of mycobacterial lipids, and on the significant progress in lipidomics, in recent times. The chapters present comprehensive, yet systematic cutting-edge research, comprising mycobacterial lipid terminologies, classifications, biosynthetic pathways, tools and techniques, and functional burgeoning. This unique reference book has contributions from pioneer researchers, experts, and eminent veterans from around the globe. It covers ground-breaking work that will bridge the gap between understanding biochemical patterns related to virulence, pathogenesis, and resistance and elucidating new targets for drug design, identifying biomarkers for predicting risk, early diagnosis, and therapeutic outcome. Covers major biochemical aspects of mycobacterial lipids, nomenclature, structure and classification, and metabolic pathways Focuses on recent trends and state-of-the-art technology, used in mycobacterial lipids study Brings together the functional aspects of mycobacterial lipidome, involvement of lipids in cellular network and signaling, its involvement in virulence and resistance, and host factor manipulations Highlights the discovery of lipid biomarkers, for diagnostic and therapeutic interventions, using mycobacterial lipidomic studies Presents lipids at the interface of various other biomolecules with integrative omics aspects

Author : Giovanna Riccardi
Publisher : MDPI
ISBN 13 : 3039432362
Total Pages : 296 pages
Book Rating : 4.63/5 ( download)

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Download or read book Tuberculosis Drug Discovery and Development 2019 written by Giovanna Riccardi and published by MDPI. This book was released on 2020-11-24 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tuberculosis (TB) is an infectious disease caused by Mycobacterium tuberculosis and still represents one of the global health threats to mankind. The World Health Organization estimated more than 10 million new cases and reported more than 1.5 million deaths in 2019, thus ranking TB among the main causes of death due to a single pathogen. Standard anti-TB therapy includes four first-line antibiotics that should be administered for at least six months. However, in the case of multi- and extensively drug-resistant TB, second-line medications must be used and these frequently cause severe side effects resulting in poor compliance. Developing new anti-TB drug candidates is therefore of outmost importance. In this Special Issue dedicated to Tuberculosis Drug Discovery and Development, we present the main and latest achievements in the fields of drug and target discovery, host-directed therapy, anti-virulence drugs, and describe the development of two advanced compounds: macozinone and delpazolid. In addition, this Special Issue provides an historical perspective focused on Carlo Forlanini, the inventor of pneumothorax for TB treatment, and includes an overview of the state-of-the-art technologies which are being exploited nowadays in TB drug development. Finally, a summary of TB vaccines that are either approved or undergoing clinical trials concludes the Special Issue.

Author : King K. Holmes
Publisher : World Bank Publications
ISBN 13 : 1464805253
Total Pages : 506 pages
Book Rating : 4.57/5 ( download)

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Download or read book Disease Control Priorities, Third Edition (Volume 6) written by King K. Holmes and published by World Bank Publications. This book was released on 2017-11-06 with total page 506 pages. Available in PDF, EPUB and Kindle. Book excerpt: Infectious diseases are the leading cause of death globally, particularly among children and young adults. The spread of new pathogens and the threat of antimicrobial resistance pose particular challenges in combating these diseases. Major Infectious Diseases identifies feasible, cost-effective packages of interventions and strategies across delivery platforms to prevent and treat HIV/AIDS, other sexually transmitted infections, tuberculosis, malaria, adult febrile illness, viral hepatitis, and neglected tropical diseases. The volume emphasizes the need to effectively address emerging antimicrobial resistance, strengthen health systems, and increase access to care. The attainable goals are to reduce incidence, develop innovative approaches, and optimize existing tools in resource-constrained settings.

Author : World Health Organization
Publisher :
ISBN 13 : 9789241501583
Total Pages : 0 pages
Book Rating : 4.88/5 ( download)

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Download or read book Guidelines for the Programmatic Management of Drug-Resistant Tuberculosis written by World Health Organization and published by . This book was released on 2015-04-20 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This 2011 update of Guidelines for the programmatic management of drug-resistant tuberculosis is intended as a tool for use by public health professionals working in response to the Sixty-second World Health Assembly's resolution on prevention and control of multidrug-resistant tuberculosis and extensively drug-resistant tuberculosis. Resolution WHA62.15, adopted in 2009, calls on Member States to develop a comprehensive framework for the management and care of patients with drug-resistant TB. The recommendations contained in these guidelines address the most topical questions concerning the programmatic management of drug-resistant TB: case-finding, multidrug resistance, treatment regimens, monitoring the response to treatment, and selecting models of care. The guidelines primarily target staff and medical practitioners working in TB treatment and control, and partners and organizations providing technical and financial support for care of drug-resistant TB in settings where resources are limited.

Author : National Academies Of Sciences Engineeri
Publisher : National Academies Press
ISBN 13 : 9780309093378
Total Pages : pages
Book Rating : 4.76/5 ( download)

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Download or read book Systematizing the One Health Approach in Preparedness and Response Efforts for Infectious Disease Outbreaks: Proceedings of a Workshop written by National Academies Of Sciences Engineeri and published by National Academies Press. This book was released on 2022-10-11 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: On February 23-25, 2021, a planning committee convened by the Forum on Microbial Threats at the National Academies of Sciences, Engineering, and Medicine held a 3-day virtual workshop titled Systematizing the One Health Approach in Preparedness and Response Efforts for Infectious Disease Outbreaks. The workshop gave particular consideration to research opportunities, multisectoral collaboration mechanisms, community-engagement strategies, educational opportunities, and policies that speakers have found effective in implementing the core capacities and interventions of One Health principles to strengthen national health systems and enhance global health security. This publication summarizes the presentation and discussion of the workshop.

Author : World Health Organization
Publisher : World Health Organization
ISBN 13 : 9240093982
Total Pages : 42 pages
Book Rating : 4.80/5 ( download)

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Download or read book WHO Evidence Considerations for Vaccine Policy Development for Tuberculosis Vaccines Intended for Adults and Adolescents written by World Health Organization and published by World Health Organization. This book was released on 2024-05-28 with total page 42 pages. Available in PDF, EPUB and Kindle. Book excerpt: This ECVP is a new technical product that aims to anticipate and collectively delineate the clinical trial, observational and other data likely to be required by global and national policy-makers, and to do so when most valuable – during development of the late-stage clinical plan, including the design of the pivotal licensure trial. Proactively generating this evidence as part of or in parallel to clinical development – where feasible – rather than reactively post-licensure, creates an opportunity to accelerate vaccine policy formulation, adoption and impact, particularly in LMICs.