Biopharmaceutical medicinal products (biologics) represent a huge financial market. Thus upon patent protection expiry of the innovator (reference) biologic there is interest from industry to gain a portion of this market by launching a 'similar' biologic at a reduced development cost, thus boosting potential gains. The EMA responded to this desire and lead the guidance process with industry on the topic of biosimilars. Based on the experience gained with biosimilars in the past, the EMA started to introduce a second generation series of guidance documents, which take into account the past, current and possibly future challenges of biosimilars. Those proposals were evaluated by EMA and partially incorporated into new guidance documents. This work highlights the challenges and risks associated with biosimilar submissions for large and complex bio-molecules such antibodies. Results: There are unaddressed questions for the regulator with regard to the unsolved dynamic of heterogeneity and variations of the quality profile, which have potential implications on safety and efficacy. This is neglected and not taken into account seriously enough by the stakeholders. Solution: Further, the only (in my view) progressive way to deal with such foreseeable situations from the biosimilar developer’s point of view is to incorporate a design space.
There are fewer grounds today than in the past to deplore a North‑South divide in research and innovation. This is one of the key findings of the UNESCO Science Report: towards 2030. A large number of countries are now incorporating science, technology and innovation in their national development agenda, in order to make their economies less reliant on raw materials and more rooted in knowledge. Most research and development (R&D) is taking place in high-income countries, but innovation of some kind is now occurring across the full spectrum of income levels according to the first survey of manufacturing companies in 65 countries conducted by the UNESCO Institute for Statistics and summarized in this report. For many lower-income countries, sustainable development has become an integral part of their national development plans for the next 10–20 years. Among higher-income countries, a firm commitment to sustainable development is often coupled with the desire to maintain competitiveness in global markets that are increasingly leaning towards ‘green’ technologies. The quest for clean energy and greater energy efficiency now figures among the research priorities of numerous countries. Written by more than 50 experts who are each covering the country or region from which they hail, the UNESCO Science Report: towards 2030 provides more country-level information than ever before. The trends and developments in science, technology and innovation policy and governance between 2009 and mid-2015 described here provide essential baseline information on the concerns and priorities of countries that could orient the implementation and drive the assessment of the 2030 Agenda for Sustainable Development in the years to come.
This publication argues that Latin America and the Caribbean are in a position to move towards a "big push for sustainability" through a combination of economic, industrial, social and environmental policies capable of driving an equal and sustainable recovery and relaunching development in the region. Comprised of five chapters, the publication studies the three crises (slow growth, growing inequality and the environmental emergency) affecting economies and societies around the world, placing particular focus on those of Latin America and the Caribbean. It goes on to present a framework for analysing these crises in an integrated manner and measuring their magnitude in the specified regions. It then examines the quantitative impacts on growth, emissions, income distribution and the external sector under different policy scenarios, highlighting the potential of various policy combinations to forge a more dynamic growth path, with lower emissions and greater equality. Further identifying seven sectors that can drive sustainable development and proposing policies to foster these sectors, the publication concludes with an analysis that links up macroeconomic, industrial, social and environmental policies and the role of the State in building consensus for their implementation.
This book provides an overview of the global pharmaceutical pricing policies. Medicines use is increasing globally with the increase in resistant microbes, emergence of new treatments, and because of awareness among consumers. This has resulted in increased drug expenditures globally. As the pharmaceutical market is expanding, a variety of pharmaceutical pricing strategies and policies have been employed by drug companies, state organizations and pharmaceutical pricing authorities.
Wide-Ranging Coverage of Parametric Modeling in Linear and Nonlinear Mixed Effects ModelsMixed Effects Models for the Population Approach: Models, Tasks, Methods and Tools presents a rigorous framework for describing, implementing, and using mixed effects models. With these models, readers can perform parameter estimation and modeling across a whol
Human rights violations and traumatic events often comingle in victims’ experiences; however, the human rights framework and trauma theory are rarely deployed together to illuminate such experiences. This edited volume explores the intersection of trauma and human rights by presenting the development and current status of each of these frameworks, examining traumatic experiences and human rights violations across a range of populations and describing efforts to remediate them. Individual chapters address these topics among Native Americans, African Americans, children, women, lesbian/gay/bisexual/transgender individuals, those with mental disabilities, refugees and asylees, and older adults, and also in the context of social policy and truth and reconciliation commissions. The authors demonstrate that the trauma and human rights frameworks each contribute invaluable and complementary insights, and that their integration can help us fully appreciate and address human suffering at both individual and collective levels.
This 1897 directory of Terrebonne Parish is a trove of information regarding this region of Louisiana. The volume contains information on lawyers, doctors, local businesses, and local school systems. The directory provides essential information for a researcher, genealogist, or curious reader. This work has been selected by scholars as being culturally important, and is part of the knowledge base of civilization as we know it. This work is in the "public domain in the United States of America, and possibly other nations. Within the United States, you may freely copy and distribute this work, as no entity (individual or corporate) has a copyright on the body of the work. Scholars believe, and we concur, that this work is important enough to be preserved, reproduced, and made generally available to the public. We appreciate your support of the preservation process, and thank you for being an important part of keeping this knowledge alive and relevant.
The Model recommends guiding principles and harmonized definitions and specifies the attributes of effective and efficient regulation to be embodied within binding and enforceable law. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF). The Model is particularly relevant for WHO Member States with little or no regulation for medical devices currently in place but with the ambition to improve this situation. It foresees that such countries will progress from basic regulatory controls towards an expanded level to the extent that their resources allow. The Model is written for the legislative, executive, and regulatory branches of government as they develop and establish a system of medical devices regulation. It describes the role and responsibilities of a country's regulatory authority for implementing and enforcing the regulations. Also, it describes circumstances in which a regulatory authority may either "rely on" or "recognize" the work products from trusted regulatory sources (such as scientific assessments, audit, and inspection reports) or from the WHO Prequalification Team. Section 2 of this document recommends definitions of the terms "medical devices" and IVDs. It describes how they may be grouped according to their potential for harm to the patient or user and specifies principles of safety and performance that the device manufacturer must adhere to. It explains how the manufacturer must demonstrate to a regulatory authority that its medical device has been designed and manufactured to be safe and to perform as intended during its lifetime. Section 3 presents the principles of good regulatory practice and enabling conditions for effectively regulating medical devices. It then introduces essential tools for regulation, explaining the function of the regulatory entity and the resources required. Section 4 presents a stepwise approach to implementing and enforcing regulatory controls for medical devices as the regulation progresses from a basic to an expanded level. It describes elements from which a country may choose according to national priorities and challenges. Also, it provides information on when the techniques of reliance and recognition may be considered and on the importance of international convergence of regulatory practice.Section 5 provides a list of additional topics to be considered when developing and implementing regulations for medical devices. It explains the relevance of these topics and provides guidance for regulatory authorities to ensure that they are addressed appropriately. The Model outlines a general approach but cannot provide country-specific guidance on implementation. While it does not offer detailed guidance on regulatory topics, it contains references to relevant documents where further information may be found. It does not detail the responsibilities of other stakeholders such as manufacturers, distributors, procurement agencies, and health-care professionals, all of whom have roles in assuring the quality, safety, and performance of medical devices.
Endodontic Microbiology, Second Edition presents a comprehensive reference to the microbiology, pathogenesis, management, and healing of endodontic pathosis, emphasizing the importance of biological sciences in understanding and managing endodontic disease and its interaction with systemic health. Provides a major revision to the first book to focus on the problems related to microbes in the root canal and periapical tissues Updates current knowledge in endodontic pathosis, especially regarding next generation sequencing and microbial virulence Presents useful diagrams, images, radiographs, and annotated histological images to illustrate the concepts Emphasizes the importance of biological science in understanding and managing endodontic disease Includes contributions from the leading researchers and educators in the field
More than two million medical students, doctors and other health professionals from around the globe have owned a copy of Davidson’s Principles and Practice of Medicine since it was first published. Today’s readers rely on this beautifully illustrated text to provide up-to-date detail of contemporary medical practice, presented in a style that is concise and yet easy to read. Davidson’s provides the factual knowledge required to practise medicine, explaining it in the context of underlying principles, basic science and research evidence, and shows how to apply this knowledge to the management of patients who present with problems rather than specific diseases. The book has won numerous prizes including being highly commended in the British Medical Association book awards. Davidson’s global perspective is enhanced by the input of an international team of authors and a distinguished International Advisory Board from 17 countries. Building on the foundations laid down by its original editor, Davidson’s remains one of the world’s leading and most respected textbooks of medicine. The underlying principles of medicine are described concisely in the first part of the book, and the detailed practice of medicine within each sub-specialty is described in later system-based chapters. Most chapters begin with a two-page overview of the important elements of the clinical examination, including a manikin to illustrate the key steps in the examination of the relevant system. A practical, problem-based clinical approach is described in the ‘Presenting Problems’ sections, to complement the detailed descriptions of each disease. The text is extensively illustrated, with over 1000 diagrams, clinical photographs, and radiology and pathology images. 1350 text boxes present information in a way suitable for revision, including 150 clinical evidence boxes summarising the results of systematic reviews and randomised controlled trials and 65 ’In Old Age’ boxes highlighting important aspects of medical practice in the older population. A combined index and glossary of medical acronyms contains over 10 000 subject entries. The contents can also be searched comprehensively as part of the online access to the whole book on the StudentConsult platform. Access over 500 self-testing questions with answers linked to the book’s content for further reading. The text uses both SI and non-SI units to make it suitable for readers throughout the globe. A new chapter specifically on Stroke Disease recognises the emergence of Stroke Medicine as a distinct clinical and academic discipline. A rationalisation of the 1350 boxes used throughout the book gives a simpler and clearer presentation of the various categories. New ‘In Adolescence’ boxes recognise the fact that many chronic disorders begin in childhood and become the responsibility of physicians practising adult medicine. These boxes acknowledge the overlap ‘transitional’ phase and highlight the key points of importance when looking after young people. The regular introduction of new authors and editors maintains the freshness of each new edition. On this occasion Dr Ian Penman has joined the editorial team and 18 new authors bring new experience and ideas to the content and presentation of the textbook. An expanded International Advisory Board of 38 members includes new members from several different countries.
