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Author : Robert V. Cerwinski
Publisher :
ISBN 13 : 9781539286721
Total Pages : 686 pages
Book Rating : 4.2/5 (867 download)
Download or read book Guide to Biosimilars Litigation and Regulation in the U.S. written by Robert V. Cerwinski and published by . This book was released on 2019 with total page 686 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 : 9781731923752
Total Pages : 0 pages
Book Rating : 4.9/5 (237 download)
Download or read book Guide to Biosimilars Litigation and Regulation in the U.S. written by and published by . This book was released on 2022 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Iqbal Ramzan
Publisher : John Wiley & Sons
ISBN 13 : 1119564654
Total Pages : 328 pages
Book Rating : 4.1/5 (195 download)
Download or read book Biologics, Biosimilars, and Biobetters written by Iqbal Ramzan and published by John Wiley & Sons. This book was released on 2021-02-03 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive primer and reference, this book provides pharmacists and health practitioners the relevant science and policy concepts behind biologics, biosimilars, and biobetters from a practical and clinical perspective. Explains what pharmacists need to discuss the equivalence, efficacy, safety, and risks of biosimilars with physicians, health practitioners, and patients about Guides regulators on pragmatic approaches to dealing with these drugs in the context of rapidly evolving scientific and clinical evidence Balances scientific information on complex drugs with practical information, such as a checklist for pharmacists
Author : Hiten J. Gutka
Publisher : Springer
ISBN 13 : 3319996800
Total Pages : 709 pages
Book Rating : 4.3/5 (199 download)
Download or read book Biosimilars written by Hiten J. Gutka and published by Springer. This book was released on 2018-12-13 with total page 709 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development. For the ease of readers, the book comprises of six sections as follows: Section I: Business, Health Economics and Intellectual Property Landscape for Biosimilars Section II: Regulatory Aspects of Development and Approval for Biosimilars Section III: Biopharmaceutical Development and Manufacturing of Biosimilars Section IV: Analytical Similarity Considerations for Biosimilars Section V: Clinical aspects of Biosimilar Development Section VI: Biosimilars- Global Development and Clinical Experience Chapters have been written by one or more experts from academia, industry or regulatory agencies who have been involved with one or more aspects of biosimilar product development. The authors and editors have an expertise in commercialization and pricing of biosimilars, intellectual property considerations for biosimilars, chemistry manufacturing controls (CMC) and analytical development for biosimilars, regulatory and clinical aspects of biosimilar development. Besides the industry practitioners, the book includes several contributions from regulators across the globe.
Author : World Intellectual Property Organization
Publisher : WIPO
ISBN 13 : 9280523082
Total Pages : 259 pages
Book Rating : 4.2/5 (85 download)
Download or read book Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade written by World Intellectual Property Organization and published by WIPO. This book was released on 2013 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.
Author : Lawton R. Burns
Publisher : Cambridge University Press
ISBN 13 : 9780521838986
Total Pages : 400 pages
Book Rating : 4.8/5 (389 download)
Download or read book The Business of Healthcare Innovation written by Lawton R. Burns and published by Cambridge University Press. This book was released on 2005-08-25 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first wide-ranging analysis of business trends in the manufacturing segment of the health care industry.
Author : Ellen F. M. 't Hoen
Publisher :
ISBN 13 : 9789079700851
Total Pages : 181 pages
Book Rating : 4.7/5 (8 download)
Download or read book Private Patents and Public Health written by Ellen F. M. 't Hoen and published by . This book was released on 2016 with total page 181 pages. Available in PDF, EPUB and Kindle. Book excerpt: Millions of people around the world do not have access to the medicines they need to treat disease or alleviate suffering. Strict patent regimes introduced following the establishment of the World Trade Organization in 1995 interfere with widespread access to medicines by creating monopolies that keep medicines prices well out of reach for many. 0The AIDS crisis in the late nineties brought access to medicines challenges to the public?s attention, when millions of people in developing countries died from an illness for which medicines existed, but were not available or affordable. Faced with an unprecedented health crisis ? 8,000 people dying daily ? the public health community launched an unprecedented global effort that eventually resulted in the large-scale availability of low-priced generic HIV medicines. 0But now, high prices of new medicines - for example, for cancer, tuberculosis and hepatitis C - are limiting access to treatment in low-, middle and high-income countries alike. Patent-based monopolies affect almost all medicines developed since 1995 in most countries, and global health policy is now at a critical juncture if the world is to avoid new access to medicines crises. 0This book discusses lessons learned from the HIV/AIDS crisis, and asks whether actions taken to extend access and save lives are exclusive to HIV or can be applied more broadly to new global access challenges.
Author : Robin Feldman
Publisher : Cambridge University Press
ISBN 13 : 131673949X
Total Pages : 165 pages
Book Rating : 4.3/5 (167 download)
Download or read book Drug Wars written by Robin Feldman and published by Cambridge University Press. This book was released on 2017-06-09 with total page 165 pages. Available in PDF, EPUB and Kindle. Book excerpt: While the shockingly high prices of prescription drugs continue to dominate the news, the strategies used by pharmaceutical companies to prevent generic competition are poorly understood, even by the lawmakers responsible for regulating them. In this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest. In highly engaging prose, they offer specific examples of how generic competition has been stifled for years, with costs climbing into the billions and everyday consumers paying the price. Drug Wars is a guide to the current landscape, a roadmap for reform, and a warning of what is to come. It should be read by policymakers, academics, patients, and anyone else concerned with the soaring costs of prescription drugs.
Author : MATT. LAVY HERVEY (DR MATTHEW.)
Publisher :
ISBN 13 : 9780414083028
Total Pages : pages
Book Rating : 4.0/5 (83 download)
Download or read book LAW OF ARTIFICIAL INTELLIGENCE,THE. written by MATT. LAVY HERVEY (DR MATTHEW.) and published by . This book was released on 2020 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : World Health Organization
Publisher : WHO Technical Report
ISBN 13 : 9789241210195
Total Pages : 0 pages
Book Rating : 4.2/5 (11 download)
Download or read book WHO Expert Committee on Specifications for Pharmaceutical Preparations written by World Health Organization and published by WHO Technical Report. This book was released on 2018 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: - WHO guidelines on good herbal processing practices for herbal medicines; - Guidelines on good manufacturing practices for the manufacture of herbal medicines; - Considerations for requesting analysis of medicine samples; - WHO model certificate of analysis; - WHO guidance on testing of "suspect" falsified medicines; - Good pharmacopoeial practices - Chapter on monographs for compounded preparations; - Good pharmacopoeial practices - Chapter on monographs on herbal medicines; - Guidelines on heating, ventilation and air-conditioning systems for non-sterile pharmaceutical products; - Guidance on good practices for desk assessment of compliance with good manufacturing practices, good laboratory practices and good clinical practices for medical products regulatory decisions; - Stability testing of active pharmaceutical ingredients and finished pharmaceutical products; and - Collaborative procedure in the assessment and accelerated national registration of pharmaceutical products and vaccines approved by stringent regulatory authorities.
Author : National Institutes of Health (U.S.). Division of Biologics Standard
Publisher :
ISBN 13 :
Total Pages : 40 pages
Book Rating : 4.3/5 (243 download)
Download or read book Regulation of Biological Products written by National Institutes of Health (U.S.). Division of Biologics Standard and published by . This book was released on 1960 with total page 40 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Thomas Squire Barrett
Publisher :
ISBN 13 :
Total Pages : 74 pages
Book Rating : 4.R/5 (6 download)
Download or read book Examination of Gillespie, by T.S.Barrett written by Thomas Squire Barrett and published by . This book was released on 1871 with total page 74 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : A. Bogner
Publisher : Springer
ISBN 13 : 0230244270
Total Pages : 281 pages
Book Rating : 4.2/5 (32 download)
Download or read book Interviewing Experts written by A. Bogner and published by Springer. This book was released on 2009-07-08 with total page 281 pages. Available in PDF, EPUB and Kindle. Book excerpt: Expert interviews are today a standard method of qualitative approach in the social sciences. It is surprising that methodological reflections about the expert interview are still lacking. This book gives a comprehensive overview of their theory and practice. The contributors are experienced theorists and practitioners of expert interviews.
Author :
Publisher :
ISBN 13 :
Total Pages : 272 pages
Book Rating : 4.3/5 ( download)
Download or read book Southwestern Law Review written by and published by . This book was released on 1916 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : World Intellectual Property Organization
Publisher : WIPO
ISBN 13 : 9280535153
Total Pages : 643 pages
Book Rating : 4.2/5 (85 download)
Download or read book An International Guide to Patent Case Management for Judges written by World Intellectual Property Organization and published by WIPO. This book was released on 2023-04-19 with total page 643 pages. Available in PDF, EPUB and Kindle. Book excerpt: Produced with the support of the University of California at Berkeley School of Law and the Berkeley Judicial Institute, this Guide highlights the progress achieved in patent case management in ten patent-heavy jurisdictions. The Guide offers an overview of the patent system in each jurisdiction, including the role of patent offices in evaluating and deciding on patent validity, and the judicial structures responsible for resolving patent disputes. Thereafter chapters are structured on the different stages of patent litigation in civil infringement cases. Readers can create their own custom guide by selecting any combination of jurisdictions and topics covered in the Guide. Please see the Custom guide link: https://www.wipo.int/about-patent-judicial-guide/en
Author : BIRD & BIRD. LLP
Publisher :
ISBN 13 : 9780414070547
Total Pages : pages
Book Rating : 4.0/5 (75 download)
Download or read book LIFE SCIENCES AND INTELLECTUAL PROPERTY. written by BIRD & BIRD. LLP and published by . This book was released on 2019 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : William F. Fox
Publisher :
ISBN 13 : 9781422498651
Total Pages : 0 pages
Book Rating : 4.4/5 (986 download)
Download or read book Understanding Administrative Law written by William F. Fox and published by . This book was released on 2012 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: External controls on administrative agencies : the legislative branch -- External controls on administrative agencies : the executive branch -- The exercise of agency power -- Agency decision-making : the constitutional limitations -- Agency decision-making : choosing rule or order -- Rulemaking.
