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Author:
Publisher: Academic Press
ISBN: 0128173173
Category : Medical
Languages : en
Pages : 290
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Book Description
Drug-Induced Liver Injury, Volume 85, the newest volume in the Advances in Pharmacology series, presents a variety of chapters from the best authors in the field. Chapters in this new release include Cell death mechanisms in DILI, Mitochondria in DILI, Primary hepatocytes and their cultures for the testing of drug-induced liver injury, MetaHeps an alternate approach to identify IDILI, Autophagy and DILI, Biomarkers and DILI, Regeneration and DILI, Drug-induced liver injury in obesity and nonalcoholic fatty liver disease, Mechanisms of Idiosyncratic Drug-Induced Liver Injury, the Evaluation and Treatment of Acetaminophen Toxicity, and much more. - Includes the authority and expertise of leading contributors in pharmacology - Presents the latest release in the Advances in Pharmacology series
Author:
Publisher: Academic Press
ISBN: 0128173173
Category : Medical
Languages : en
Pages : 290
Get Book Here
Book Description
Drug-Induced Liver Injury, Volume 85, the newest volume in the Advances in Pharmacology series, presents a variety of chapters from the best authors in the field. Chapters in this new release include Cell death mechanisms in DILI, Mitochondria in DILI, Primary hepatocytes and their cultures for the testing of drug-induced liver injury, MetaHeps an alternate approach to identify IDILI, Autophagy and DILI, Biomarkers and DILI, Regeneration and DILI, Drug-induced liver injury in obesity and nonalcoholic fatty liver disease, Mechanisms of Idiosyncratic Drug-Induced Liver Injury, the Evaluation and Treatment of Acetaminophen Toxicity, and much more. - Includes the authority and expertise of leading contributors in pharmacology - Presents the latest release in the Advances in Pharmacology series
Author: Pablo Figueroa
Publisher: Edward Elgar Publishing
ISBN: 1785362615
Category : Business & Economics
Languages : en
Pages : 733
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Book Description
This book provides a systematic analysis of the law and practice of EU competition and trade in the pharmaceutical sector. Authored by leading private practitioners, economists, scholars and high-level officials at competition regulators, this work provides valuable insider knowledge on the application of law and policies to the pharmaceutical industry. The work contains extensive commentary on the legislation and the latest case law and administrative precedents in this sector, at both EU and national level, including certain significant jurisdictions (e.g., the US, China). Coverage of various key developments includes the recent pay-for-delay antitrust investigations, the perennial issues around parallel trade, and an examination of mergers among pharmaceutical companies and medical devices manufacturers. In addition to the legal analysis, it offers vital economic and business perspectives to ensure that the reader has the full range of tools with which to prepare for cases and conduct transactions within the pharmaceutical industry.
Author: Amalia Athanasiadou
Publisher: Kluwer Law International B.V.
ISBN: 9403501146
Category : Law
Languages : en
Pages : 349
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Book Description
Reverse payment settlements or “pay-for-delay agreements” between originators and generic drug manufacturers create heated debates regarding the balance between competition and intellectual property law. These settlements touch upon sensitive issues such as timely generic entry and access to affordable pharmaceuticals and also the need to preserve innovation incentives for originators and to strengthen the pipeline of life-saving pharmaceuticals. This book is one of the first to critically and comparatively analyse how such patent settlements and various other strategies employed by the pharmaceutical industry are scrutinised by both United States (US) and European courts and enforcement authorities, and to discuss the applicable legal tests and the main criteria used for their assessment. The book’s ultimate objective is to provide guidance to the pharmaceutical industry regarding the types of patent settlements, strategies and conduct which may be problematic from US antitrust and European Union (EU) competition law perspectives and to assist practitioners in structuring settlements which are both efficient and compliant. To this end, an exhaustive legal analysis of some of the most controversial issues regarding pharmaceutical patent settlements is provided, including: – the lengthy split among US Circuit Courts on the issue of pay-for-delay settlements, its resolution by the US Supreme Court in FTC v. Actavisand subsequent jurisprudence; – the decision of Lundbeck v. Commissionby the European General Court and the Servier decision of the European Commission; – the Roche/Novartisdecision of the European Court of Justice and the most important decisions by National Competition Authorities on pharma patent settlements in the EU; – an overview of other types of strategies such as product-hopping and product reformulations, no-authorised generic commitments, problematic side-deals, mechanisms affecting generic substitution; – the rejection of the “scope of the patent” test in both the US and the EU and the balancing of patent law and antitrust law considerations in the prevailing applicable tests; – the benefits of settlements and the main criteria for assessing their legitimacy under US antitrust and EU competition law. The analysis provides concrete examples of both illegitimate and legitimate settlements and strategies, emphasising on conduct that falls within a grey zone and on the circumstances and criteria under which such conduct could be deemed problematic from an antitrust perspective. This book will serve as a valuable guide for pharmaceutical companies wishing to minimise the risk of engaging in conduct that could potentially infringe US antitrust and EU competition law. It further aims to save courts and enforcement agencies and also practitioners and academics considerable time and resources by providing an exhaustive analysis of the relevant caselaw, with the ultimate goal to increase legal certainty on the most controversial aspects of patent settlements in the pharmaceutical industry.
Author: Hovenkamp, Janis, Lemley, Leslie, Carrier
Publisher: Wolters Kluwer
ISBN: 1454885289
Category :
Languages : en
Pages : 3280
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Book Description
Author:
Publisher: DIANE Publishing
ISBN: 1428951938
Category :
Languages : en
Pages : 129
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Book Description
Author:
Publisher: American Bar Association
ISBN: 9781590318683
Category : Law
Languages : en
Pages : 428
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Book Description
Author: Christopher Scott Hemphill
Publisher: Stanford University
ISBN:
Category :
Languages : en
Pages : 249
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Book Description
This dissertation examines the law and economics of generic drug entry, and the problems that arise from specific U.S. regulatory arrangements that govern innovation and competition in the market for patented pharmaceuticals. As Chapter 1 explains, competitive entry by generic drug makers is limited by both patents and industry-specific regulation, which together provide the means for brand-name drug makers to avoid competition and thereby recoup large investments in research, development, and testing. At the same time, the complex rules of the Hatch-Waxman Act furnish a pathway by which generic drug makers may challenge the validity or scope of brand-name patents, with a view to entering the market with a competing product prior to patent expiration. The subsequent chapters examine several aspects of the competitive interaction between brand-name and generic drug makers. Chapter 2 analyzes settlements of patent litigation between brand-name and generic drug makers, in which the brand-name firm pays the generic firm in exchange for delayed market entry. Such pay-for-delay settlements are an important, unresolved question in U.S. antitrust policy. The analysis reveals that the pay-for-delay settlement problem is more severe than has been commonly understood. Several specific features of the Act—in particular, a 180-day bounty granted to certain generic drug makers as an incentive to pursue pre-expiration entry—widen the potential for anticompetitive harm from pay-for-delay settlements, compared to the usual understanding. In addition, I show that settlements are "innovation inefficient" as a means of providing profits and hence ex ante innovation incentives to brand-name drug makers. To the extent that Congress established a preferred tradeoff between innovation and competition when it passed the Act, settlements that implement a different, less competition-protective tradeoff are particularly problematic from an antitrust standpoint. Chapter 3 synthesizes available public information about pay-for-delay settlements in order to offer a new account of the extent and evolution of settlement practice. The analysis draws upon a novel dataset of 143 such settlements. The analysis uncovers an evolution in the means by which a brand-name firm can pay a generic firm to delay entry, including a variety of complex "side deals" by which a brand-name firm can compensate a generic firm in a disguised fashion. It also reveals several novel forms of regulatory avoidance. The analysis in the chapter suggests that, as a matter of institutional choice, an expert agency is in a relatively good position to conduct the aggregate analysis needed to identify an optimal antitrust rule. Chapter 4 examines the co-evolution of increased brand-name patenting and increased generic pre-expiration challenges. It draws upon a second novel dataset of drug approvals, applications, patents, and other drug characteristics. Its first contribution is to chart the growth of patent portfolios and pre-expiration challenges. Over time, patenting has increased, measured by the number of patents per drug and the length of the nominal patent term. During the same period, challenges have increased as well, and drugs are challenged sooner, relative to brand-name approval. The analysis shows that brand-name sales, a proxy for the profitability of the drug, have a positive effect on the likelihood of generic challenge, consistent with the view that patents that later prove to be valuable receive greater ex post scrutiny. The likelihood of challenge also varies by patent type and timing of expiration. Conditional on sales and other drug characteristics, drugs with weaker patents, particularly those that expire later than a drug's basic compound patent, face a significantly higher likelihood of challenge. Though the welfare implications of Hatch-Waxman patent challenge provisions are complicated, these results suggest these challenges serve a useful purpose, in promoting scrutiny of low quality and late-expiring patents.
Author: Phillip Areeda
Publisher: Aspen Publishing
ISBN: 1543817491
Category : Law
Languages : en
Pages : 1175
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Book Description
Distinguished authorship characterizes Antitrust Analysis: Problems, Text, and Cases, first written by Phil Areeda, the leading antitrust commentator of the 20th century. The text continues to be revised by three of the leading lawyer economists of the early 21st century. This traditional casebook is also known for its pedagogy (cases, explanatory text, and problems) and insightful text that conveys essential background information along with necessary economic principles. Recognizing that the most important development in antitrust doctrine over the past fifty years is the increasingly central role of economic analysis, the authors take great care to convey economic learning to students in plain language with a minimum of technical apparatus, resulting in a powerful volume adopted by experienced instructors and first-time teachers alike. Helpful appendices include Selected Statutes, such as the Sherman Act, the Clayton Act, and the Federal Trade Commission Act. New to the Eighth Edition: The addition of C. Scott Hemphill as a co-author, adding to the already distinguished author team. Since the last edition, antitrust enforcers and courts have struggled to grapple with the rising importance of platforms in our increasingly digital economy. The new edition gives extensive attention to these developments, including: The Supreme Court’s decision in Ohio v. American Express Major enforcement actions against Apple, Facebook, and Google New Vertical Merger Guidelines Completely rewritten and streamlined introductory material in Chapter 1. Professors and student will benefit from: Distinguished authorship: Original author Areeda was the leading antitrust commentator of the 20th century; Kaplow, Edlin, and Hemphill are leading lawyer-economists of the early 21st century. Pedagogy: Traditional casebook with cases, explanatory text, and problems. Insightful textual explanations convey essential background information and necessary economic principles. Adopted by experienced instructors and first-time teachers alike. Appendix includes selected statutes and the Sherman Act, the Clayton Act, and the Federal Trade Commission Act. Teaching materials Include: Teacher’s Manual
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241547537
Category : Business & Economics
Languages : en
Pages : 219
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Book Description
This fourth edition of the anthrax guidelines encompasses a systematic review of the extensive new scientific literature and relevant publications up to end 2007 including all the new information that emerged in the 3-4 years after the anthrax letter events. This updated edition provides information on the disease and its importance, its etiology and ecology, and offers guidance on the detection, diagnostic, epidemiology, disinfection and decontamination, treatment and prophylaxis procedures, as well as control and surveillance processes for anthrax in humans and animals. With two rounds of a rigorous peer-review process, it is a relevant source of information for the management of anthrax in humans and animals.
Author: James Langenfeld
Publisher: Emerald Group Publishing
ISBN: 1787566005
Category : Business & Economics
Languages : en
Pages : 483
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Book Description
This volume of Research in Law and Economics contains articles that address important legal and economic developments in the areas of healthcare, intellectual property and labor settlements, competitive effects, cartel overcharges, and the U.S. Federal Trade Commission (FTC)
