European Regulation of Medical Devices and Pharmaceuticals: Regulatee Expectations of Legal Certainty

 Pharmacology  Comments Off on European Regulation of Medical Devices and Pharmaceuticals: Regulatee Expectations of Legal Certainty
Sep 262018
 

One of the primary functions of law is to ensure that the legal structure governing all social relations is predictable, coherent, consistent and applicable. Taken together, these characteristics of law are referred to as legal certainty. In traditional approaches to legal certainty, law is regarded as a hierarchical system of rules characterized by stability, clarity, uniformity, calculable enforcement, publicity and predictability. However, the current reality is that national legal systems no longer operate in isolation, but within a multilevel legal order, wherein norms created at both the international and regional level are directly applicable to national legal systems. Also, norm creation is no longer the exclusive prerogative of public officials of the state: private actors have an increasing influence on norm creation as well. Social scientists have referred to this phenomenon of interacting and overlapping competences as multilevel governance. Only recently have legal scholars focused attention on the increasing interconnectedness (and therefore the concomitant loss of primacy of national legal orders) between the global, European and national regulatory spheres through the concept of multilevel regulation.
In this project the author uses multilevel regulation as a term to characterize a regulatory space in which the process of rule making, rule enforcement and rule adjudication (the regulatory lifecycle) is dispersed across more than one administrative or territorial level and amongst several different actors, both public and private. The author draws on the concept of a regulatory space, using it as a framing device to differentiate between specific aspects of policy fields. The relationship between actors in such a space is non-hierarchical and they may be independent of each other. The lack of central ordering of the regulatory lifecycle within this regulatory space is the most important feature of such a space. The implications of multilevel regulation for the notion of legal certainty have attracted limited attention from scholars and the demand for legal certainty in regulatory practice is still a puzzle. The book explores the idea of legal certainty in terms of the perceptions and expectations of regulatees in the context of medical products – specifically, pharmaceuticals and medical devices, which can be differentiated as two regulatory spaces and therefore form two case studies. As an exploratory project, the book necessarily explores new territory in terms of investigating legal certainty first in terms of regulatee perceptions and expectations and second, because it studies it in the context of multilevel regulation.

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Pharmaceutical Powder and Particles

 Pharmacology  Comments Off on Pharmaceutical Powder and Particles
Sep 252018
 

This first monograph in the new AAPS book series concisely reviews important aspects of powder and particle systems and the critical quality attributes that should be used as a guide to future developments intended to maximize the control of product quality and performance. Drs. Hickey and Giovagnoli have written an essential primer for any scientists involved in powder or particle research and manufacturing. It is appropriate for those just entering the field or as a rapid reference for the experienced pharmaceutical scientist.
The authors have both academic and industrial experience and the coverage includes solid state chemistry; crystallization; physical processes; particle size and distribution;particle interaction;manufacturing processes;quality by design;and a general discussion of the industry. Pharmaceutical Powder and Particles is intended to concisely review important aspects of powder and particle systems and the critical quality attributes that should be used as a guide to future developments intended to maximize the control of product quality and performance.

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Oral Pharmacology for the Dental Hygienist (2nd Edition)

 Dentistry, Pharmacology  Comments Off on Oral Pharmacology for the Dental Hygienist (2nd Edition)
Sep 252018
 

Oral Pharmacology for the Dental Hygienist, Second Edition, offers a comprehensive review of the principles of pharmacology and their application to dental hygiene practice. This practical textbook covers many oral manifestations of drugs of which the dental hygiene student should be aware. Quick drug guides, fun facts, and unique rapid dental hints in each chapter help students understand different pharmacologic principles while reinforcing key information. Case studies extensively review the medical conditions, potential drug interactions, and dental management of drug interactions.

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Comprehensive Pharmacy Review for NAPLEX, 8th Edition

 Pharmacology  Comments Off on Comprehensive Pharmacy Review for NAPLEX, 8th Edition
Sep 222018
 

Ideal for anyone studying for the North American Pharmacists Licensure Examination (NAPLEX), this indispensible 8th edition of Comprehensive Pharmacy Review for NAPLEX: Practice Exams, Cases, and Test Prep deciphers the nuances of the test and provides authentic exercises and actionable strategies. Using 2 full-length tests, 32 brand-new patient cases, and more than 200 practice calculations, you can challenge your understanding of current pharmacological practices and enhance your test-taking skills.

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3D Printing of Pharmaceuticals

 Pharmacology  Comments Off on 3D Printing of Pharmaceuticals
Sep 172018
 


3D printing is forecast to revolutionise the pharmaceutical sector, changing the face of medicine development, manufacture and use. Potential applications range from pre-clinical drug development and dosage form design through to the fabrication of functionalised implants and regenerative medicine. Within clinical pharmacy practice, printing technologies may finally lead to the concept of personalised medicines becoming a reality.
This volume aims to be the definitive resource for anyone thinking of developing or using 3D printing technologies in the pharmaceutical sector, with a strong focus on the translation of printing technologies to a clinical setting. This text brings together leading experts to provide extensive information on an array of 3D printing techniques, reviewing the current printing technologies in the pharmaceutical manufacturing supply chain, in particular, highlighting the state-of-the-art applications in medicine and discussing modern medicine manufacture from a regulatory perspective. This book is a highly valuable resource for a range of demographics, including academic researchers and the pharmaceutical industry, providing a comprehensive inventory detailing the current and future applications of 3D printing in pharmaceuticals.

Professor Abdul Basit is a Professor of Pharmaceutics at the UCL School of Pharmacy, University College London. Abdul’s research sits at the interface between pharmaceutical science and gastroenterology, forging links between basic science and clinical outcomes. His research has been translated into the design of new technologies and improved disease treatments, many of which have been commercialised. Abdul is also a serial entrepreneur and has filed multiple patents, is the recepient of several research awards and has founded 3 companies (Kuecept, Intract Pharma, FabRx). He further serves as a consultant to many pharmaceutical organisations and is on the advisory boards of scientific journals, healthcare and charitable bodies.

Professor Simon Gaisford holds a Chair in Pharmaceutics and is Head of the Department of Pharmaceutics at the UCL School of Pharmacy, University College London. He has published 110 papers, 8 book chapters, 4 authored books and is the recipient of multiple research awards. His research is focused on novel technologies for manufacturing medicines, particularly using ink-jet printing and 3D printing, translating his expertise by co-founding FabRx. Simon is also an expert in the physicochemical characterisation of compounds and formulations with thermal methods and calorimetry.

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Essentials of Pharmacology for Dentistry, 3rd Edition

 Dentistry, Pharmacology  Comments Off on Essentials of Pharmacology for Dentistry, 3rd Edition
Aug 272018
 

• All chapters are thoroughly revised and updated with latest information and new drugs
• Presentation and illustrations have been improved
• Leading trade names and dosage forms of drugs generally prescribed by dentists are mentioned distinctively
• The book is divided into three sections. The first section describes the general pharmacological principles involved in drug therapy, the second section deals with systemic pharmacology presents a brief account of drugs acting on various organ systems and used in the treatment of common disorders affecting these systems
• The third section covers antimicrobials and other drugs which the dentists prescribe or administer themselves
• Each chapter is organised systematically
• The opening sentence defines the class of drugs, followed by their classification presented in chart form for better pictorial impression and easy remembrance
• The ‘prototype’ approach is followed by describing the representative drug of the class
• Matters particularly relevant to dental therapeutics have been highlighted by italicizing
• Wherever applicable, the implications in dentistry are prominently elaborated, e.g. drugs and diseases affecting post extraction haemostasis, dental procedures in patients on corticosteroid therapy or in diabetics, oral complications of cancer chemotherapy, conscious sedation in dentistry, etc
• Focuses on drugs of greater relevance in dentistry, such as application of analgesics and NSAIDs in dental pain, dental anaesthesia, role of each class of antimicrobials in orodental infections, prophylaxis of post extraction wound infection and endocarditis in patients at special risk are emphasized
• Guidelines for prophylaxis of HIV infection are provided
• Drugs and aids having specific application in dental disorders and in dental care, e.g. drugs for dental plaque, caries tooth, dentine sensitivity along with aids like dentifrices, bleaching agents, disclosing agents, etc. are described in a separate chapter, pointing out their role in current practice
• Management of medical emergencies, like fainting, hypoglycaemia, allergic/anaphylactic reaction, angina pectoris or myocardial infarction, asthmatic attack or seizures are outlined in a new chapter, along with a list of medicines that should be kept in the emergency tray
• Last chapter on drug interactions highlights drugs commonly encountered in dental practice, such as antiplaque drugs, anticaries drugs, desensitizing agents, dentifrices, etc
• Care has been taken that the syllabus prescribed by the Dental Council of India is fully covered
• New improved layout, highlighting important points, numerous figures, charts, tables, and informative boxes make the book highly user-friendly
• Thus, the book is oriented to provide core and contemporary pharmacological knowledge which can be easily assimilated by dental students, as well as serve to help dental practitioners in treating oro-dental conditions

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Pharmaceutical Chemistry, Volume 2 : Drugs and Their Biological Targets

 Pharmacology  Comments Off on Pharmaceutical Chemistry, Volume 2 : Drugs and Their Biological Targets
Aug 272018
 

This two volume book is an excellent introduction to this interdisciplinary area, lying on the interface between organic chemistry, biochemistry and medicine. The authors give a comprehensive overview of the field and outline the actual challenges in pharmaceutical science and industry. Volume 2 covers neurotransmitters, antihistamines, enzymatic inhibitors and nonsteroidal anti-inflammatory drugs.

Prof. Joaquin M. Campos Rosa, Prof. Encarnacion Camacho Quesada, University of Granada, Granada, Spain.

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The Wiley-Blackwell Handbook of Addiction Psychopharmacology

 Pharmacology, Psychiatry  Comments Off on The Wiley-Blackwell Handbook of Addiction Psychopharmacology
Aug 212018
 

The Wiley-Blackwell Handbook of Addiction Psychopharmacology is an authoritative collection of the most current research approaches to the study of drug addiction.
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Behavioral Pharmacology of Neuropeptides: Oxytocin

 Neurology/Neurosurgery, Pharmacology  Comments Off on Behavioral Pharmacology of Neuropeptides: Oxytocin
Aug 202018
 

This volume collects cutting-edge expert reviews in the oxytocin field and will be of interest to a broad scientific audience ranging from social neuroscience to clinical psychiatry. The role of the neuropeptide oxytocin in social behaviors is one of the earliest and most significant discoveries in social neuroscience. Influential studies in animal models have delineated many of the neural circuits and genetic components that underlie these behaviors.

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Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment (Schaefer) – 3rd Edition

 Ob/Gynae, Pharmacology  Comments Off on Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment (Schaefer) – 3rd Edition
Aug 202018
 

Drugs During Pregnancy and Lactation, 3rd Edition is a quick and reliable reference for all those working in disciplines related to fertility, pregnancy, lactation, child health and human genetics who prescribe or deliver medicinal products, and to those who evaluate health and safety risks. Each chapter contains twofold information regarding drugs that are appropriate for prescription during pregnancy and an assessment of the risk of a drug when exposure during pregnancy has already occurred. Thoroughly updated with current regulations, references to the latest pharmacological data, and new medicinal products, this edition is a comprehensive resource covering latest knowledge and findings related to drugs during lactation and pregnancy.

  • Provides evidence-based recommendations to help clinicians make appropriate recommendations
  • Uniquely organized and structured according to drug class and treatment indications to offer authoritative clinical content on potential adverse effects
  • Highlights new research developments from primary source about working mechanism of substances that cause developmental disorders

Editorial Reviews

Review

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