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Update on the transition to dolutegravir-based antiretroviral therapy

Update on the transition to dolutegravir-based antiretroviral therapy PDF Author: World Health Organization
Publisher: World Health Organization
ISBN: 9240053336
Category : Medical
Languages : en
Pages : 23

Book Description


Update on the transition to dolutegravir-based antiretroviral therapy

Update on the transition to dolutegravir-based antiretroviral therapy PDF Author: World Health Organization
Publisher: World Health Organization
ISBN: 9240053336
Category : Medical
Languages : en
Pages : 23

Book Description


 PDF Author:
Publisher: World Health Organization
ISBN: 9240100296
Category :
Languages : en
Pages : 40

Book Description


FDA's Drug Review Process and the Package Label

FDA's Drug Review Process and the Package Label PDF Author: Tom Brody
Publisher: Academic Press
ISBN: 0128146486
Category : Medical
Languages : en
Pages : 671

Book Description
FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of the drug. In detail, the book reproduces data on efficacy and safety from one hundred different FDA-submissions (NDAs, BLAs). The book reproduces comments and complaints from FDA reviewers regarding data that are fragmentary, ambiguous, or that detract from the drug's approvability, and the book reveals how sponsors overcame FDA's concerns and how sponsors succeeded in persuading FDA to grant approval of the drug. The book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely text and data from NDAs and BLAs, as published on FDA's website. The source material for writing this book included about 80,000 pages from FDA's Medical Reviews, FDA's Clinical Pharmacology Reviews, and FDA's Pharmacology Reviews, from one hundred different NDAs or BLAs for one hundred different drugs. Each chapter focuses on a different section of the package label, e.g., the Dosage and Administration section or the Drug Interactions section, and demonstrates how the sponsor's data supported that section of the package label. - Reveals strategies for winning FDA approval and for drafting the package label - Examples are from one hundred FDA-submissions (NDAs, BLAs) for one hundred different drugs, e.g., for oncology, metabolic diseases, autoimmune diseases, and neurological diseases - This book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely, the data from NDAs and BLAs as published on FDA's website at the time FDA grants approval to the drug

Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection

Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection PDF Author: World Health Organization
Publisher:
ISBN: 9789241549684
Category : AIDS (Disease)
Languages : en
Pages : 429

Book Description
These guidelines provide guidance on the diagnosis of human immunodeficiency virus (HIV) infection, the use of antiretroviral (ARV) drugs for treating and preventing HIV infection and the care of people living with HIV. They are structured along the continuum of HIV testing, prevention, treatment and care. This edition updates the 2013 consolidated guidelines on the use of antiretroviral drugs following an extensive review of evidence and consultations in mid-2015, shared at the end of 2015, and now published in full in 2016. It is being published in a changing global context for HIV and for health more broadly.

Primary health care and HIV: convergent actions. Policy considerations for decision-makers

Primary health care and HIV: convergent actions. Policy considerations for decision-makers PDF Author: World Health Organization
Publisher: World Health Organization
ISBN: 9240077065
Category : Medical
Languages : en
Pages : 56

Book Description
The 2030 health-related Sustainable Development Goals call on countries to end AIDS as a public health threat and also to achieve universal health coverage. The World Health Organization (WHO) promotes primary health care (PHC) as the key mechanism for achieving universal health coverage, and the PHC approach is also essential for ending AIDS and reaching other Sustainable Development Goal targets. This publication helps decision-makers to consider and optimize the synergies between existing and future assets and investments intended for both PHC and disease-specific responses, including HIV.

Antiviral Drug Discovery and Development

Antiviral Drug Discovery and Development PDF Author: Xinyong Liu
Publisher: Springer Nature
ISBN: 9811602670
Category : Medical
Languages : en
Pages : 357

Book Description
This book summarizes state-of-the-art antiviral drug design and discovery approaches starting from natural products to de novo design, and provides a timely update on recently approved antiviral drugs and compounds in advanced clinical development. Special attention is paid to viral infections with a high impact on the world population or highly relevant from the public health perspective (HIV, hepatitis C, influenza virus, etc.). In these chapters, limitations associated with adverse effects and emergence of drug resistance are discussed in detail. In addition to classical antiviral strategies, chapters will be dedicated to discuss the non-classical drug development strategies to block viral infection, for instance, allosteric inhibitors, covalent antiviral agents, or antiviral compounds targeting protein–protein interactions. Finally, current prospects for producing broad-spectrum antiviral inhibitors will be also addressed. The book is distinctive in providing the most recent update in the rapidly evolving field of antiviral therapeutics. Authoritative reviews are written by international scientists well known for their contributions in their topics of research, which makes this book suitable for researchers not only within the antiviral research community but also attractive to a broad audience in the drug discovery field. This book covers molecular structures and biochemical mechanisms mediating the antiviral effects, while discussing various ligand design strategies, which include traditional medicinal chemistry, computational chemistry, and chemical biology approaches. The book provides a comprehensive review of antiviral drug discovery and development approaches, particularly focusing on current innovations and future trends.

HIV drug resistance strategy, 2021 update

HIV drug resistance strategy, 2021 update PDF Author:
Publisher: World Health Organization
ISBN: 9240030565
Category : Medical
Languages : en
Pages : 36

Book Description


A Guide to the Clinical Care of Women with HIV

A Guide to the Clinical Care of Women with HIV PDF Author: Jean R. Anderson
Publisher: DIANE Publishing Inc.
ISBN: 9780160726118
Category : Health & Fitness
Languages : en
Pages : 636

Book Description
NOTE: NO FURTHER DISCOUNT FOR THIS PRODUCT ITEM -OVERSRTOCK SALE-- Significantly reduced price. Edited by Jean R. Anderson. This guide addresses the health care needs unique to women with HIV. It targets clinicians who provide primary care to women as well as those seeking an understanding of how to take care of women with HIV/AIDS. This guide includes tables, figures, color plates, resources, references, and indices. This 2005 edition includes new chapters on international issues and nutrition. Edge indexed."

Perinatal HIV, An Issue of Clinics in Perinatology, E-Book

Perinatal HIV, An Issue of Clinics in Perinatology, E-Book PDF Author: Ann Chahroudi
Publisher: Elsevier Health Sciences
ISBN: 0443129142
Category : Medical
Languages : en
Pages : 225

Book Description
In this issue of Clinics in Perinatology, guest editors Drs. Ann Chahroudi and Avy Violari bring their considerable expertise to the topic of Perinatal HIV. The goal of perinatal HIV transmission elimination requires assuring prenatal care, HIV screening, and treatment during pregnancy. This important issue addresses critical clinical topics such as clinical care, prevention, and research to provide a state-of-the-art review of this topic. - Contains 14 practice-oriented topics including standard of care for prevention of perinatal HIV transmission and challenges in different regions; treatment of pediatric HIV infection; neurocognitive outcomes following perinatal HIV infection; care of the child perinatally exposed to HIV; state-of-the-art research in perinatal HIV; and more. - Provides in-depth clinical reviews of perinatal HIV, offering actionable insights for clinical practice. - Presents the latest information on this timely, focused topic under the leadership of experienced editors in the field. Authors synthesize and distill the latest research and practice guidelines to create clinically significant, topic-based reviews.

Economic Evaluation in Clinical Trials

Economic Evaluation in Clinical Trials PDF Author: Henry A. Glick
Publisher: OUP Oxford
ISBN: 0191508055
Category : Medical
Languages : en
Pages : 265

Book Description
It is becoming increasingly important to examine the relationship between the outcomes of a clinical trial and the costs of the medical therapy under study. The results of such analysis can affect reimbursement decisions for new medical technologies, drugs, devices or diagnostics. It can aid companies seeking to make claims about the cost-effectiveness of their product, as well as allowing early consideration of the economic value of therapies which may be important to improving initial adoption decisions. It is also vital for addressing the requirements of regulatory bodies. Economic Evaluation in Clinical Trials provides practical advice on how to conduct cost-effectiveness analyses in controlled trials of medical therapies. This new edition has been extensively rewritten and revised; topics discussed range from design issues such as the types of services that should be measured and price weights, to assessment of quality-adjusted life years. Illustrative materials, case histories and worked examples are included to encourage the reader to apply the methods discussed. These exercises are supported with datasets, programmes and solutions made available online.