Understanding Pharma PDF Download

Author: John J. Campbell
Publisher: Pharmaceutical Press
ISBN: 9780976309635
Category : Pharmaceutical industry
Languages : en
Pages : 311

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Author: John J. Campbell
Publisher: Pharmaceutical Press
ISBN:
Category : Pharmaceutical industry
Languages : en
Pages : 272

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Author: Brian K. Nunnally
Publisher: CRC Press
ISBN: 9781420054408
Category : Medical
Languages : en
Pages : 224

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Book Description
The pharmaceutical industry is under increasing pressure to do more with less. Drug discovery, development, and clinical trial costs remain high and are subject to rampant inflation. Ever greater regulatory compliance forces manufacturing costs to rise despite social demands for more affordable health care. Traditional methodologies are failing and the industry needs to find new and innovative approaches for everything it does. Six Sigma in the Pharmaceutical Industry: Understanding, Reducing, and Controlling Variation in Pharmaceuticals and Biologics is the first book to focus on the building blocks of understanding and reducing variation using the Six Sigma method as applied specifically to the pharmaceutical industry. It introduces the fundamentals of Six Sigma, examines control chart theory and practice, and explains the concept of variation management and reduction. Describing the approaches and techniques responsible for their own significant success, the authors provide more than just a set of tools, but the basis of a complete operating philosophy. Allowing other references to cover the structural elements of Six Sigma, this book focuses on core concepts and their implementation to improve the existing products and processes in the pharmaceutical industry. The first half of the book uses simple models and descriptions of practical experiments to lay out a conceptual framework for understanding variation, while the second half introduces control chart theory and practice. Using case studies and statistics, the book illustrates the concepts and explains their application to actual workplace improvements. Designed primarily for the pharmaceutical industry, Six Sigma in the Pharmaceutical Industry: Understanding, Reducing, and Controlling Variation in Pharmaceuticals and Biologics provides the fundamentals of variation management and reduction in sufficient detail to assist in transforming established methodologies into new and efficient techniques.

Author: Mary Ann Stuhan
Publisher: ASHP
ISBN: 1585283606
Category : Medical
Languages : en
Pages : 1016

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Book Description
Using language and organization aimed directly at pharmacy technicians, Understanding Pharmacology for Pharmacy Technicians offers more than 700 pages of practical applications, safety issues and error prevention, and illustrative cases that not only explain how but why. Throughout the book, anatomy and physiology are discussed in relation to various disorders and associated pharmacotherapies to give the pharmacy technician students a context for how drugs work. Students using this book will learn the therapeutic effects of prescription medications, nonprescription medications, and alternative therapies commonly used to treat diseases affecting that system, and their adverse effects. An emphasis is placed on practical applications for the technician. What types of issues will technicians encounter at work? What is their role in patient education? How do they work with the pharmacist? Key features throughout the book: 77 case studies, including 249 case study questions More than 1,200 drugs discussed Pronunciations for difficult terms or words such as disease names Numerous figures and illustrations Alerts that point out areas of potential dangers or errors, including look-alike/sound-alike drugs. 335 practice points, including mention of any FDA-required patient medication guides, and any “special” drug storage and dispensing considerations, including beyond-use dating of open multi-use products. 110 commonly used and comprehensive drug tables. Chapter review questions The book’s content is written to meet ASHP accreditation standards and, therefore, is one of the most comprehensive books on the market related to pharmacology for technicians. For additional resources related to the book, visit www.ashp.org/techpharmacology.

Author: Martin A. Voet
Publisher: BrownWalker Press
ISBN: 1627347461
Category : Law
Languages : en
Pages : 240

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Book Description
This Sixth Edition of The Generic Challenge provides important new updates on current regulatory, legal and commercial issues affecting brand and generic pharmaceutical products, including new laws establishing generics for biologics, and changes brought about by the recently enacted America Invents Act. It explains clearly and understandably the roles of patents, FDA regulation of drugs and the Hatch Waxman Act in commercial drug development in light of generic challenges and how improvements in innovative drug products provide benefits to patients while extending the commercial lives of the drugs. There is simply no other book of its kind on this important subject.

Author: Gerald Posner
Publisher: Simon and Schuster
ISBN: 1501152033
Category : Business & Economics
Languages : en
Pages : 816

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Book Description
"Exorbitant prices for lifesaving drugs, safety recalls affecting tens of millions of Americans, and soaring rates of addiction and overdose on prescription opioids have caused many to lose faith in pharmaceutical companies. Now, Americans are demanding national reckoning with a monolithic industry. In Pharma, award-winning journalist and New York Times best-selling author Gerald Posner uncovers the real story of the Sacklers, the family that became one of America's wealthiest from the success of OxyContin, their blockbuster narcotic painkiller at the centure of the opioid crisis. The unexpected twists and turns of the Sakler family saga are told against the startling chronicle of a powerful industry that sits at the intersection of public health and profits. Pharma reveals how and why American drug companies have put earnings ahead of patients"--

Author: Mondher Toumi
Publisher: CRC Press
ISBN: 1315314584
Category : Medical
Languages : en
Pages : 310

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Book Description
Market access is the fourth hurdle in the drug development process and the primary driver for global income of any new drug. Without a strategy in place for pricing, showing value for effectiveness and an understanding of the target purchasers’ needs, the drug will fail to reach its intended market value. Introduction to Market Access for Pharmaceuticals is based on an accredited course in this area, taken from the European Market Access University Diploma (EMAUD), and is affiliated with Aix Marseille University. Key Features: The first guide to market access for pharmaceuticals based on tested teaching materials Addresses both pharmaceutical and vaccine products Includes case studies and scenarios Covers market access consdierations for Western Europe, the USA, Japan and China Explains the impact the changing healthcare market will have on your product

Author: Ben Goldacre
Publisher: Macmillan
ISBN: 0865478066
Category : Business & Economics
Languages : en
Pages : 479

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Book Description
Argues that doctors are deliberately misinformed by profit-seeking pharmaceutical companies that casually withhold information about drug efficacy and side effects, explaining the process of pharmaceutical data manipulation and its global consequences. By the best-selling author of Bad Science.

Author: Kunal Roy
Publisher: Academic Press
ISBN: 0128016337
Category : Medical
Languages : en
Pages : 484

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Book Description
Understanding the Basics of QSAR for Applications in Pharmaceutical Sciences and Risk Assessment describes the historical evolution of quantitative structure-activity relationship (QSAR) approaches and their fundamental principles. This book includes clear, introductory coverage of the statistical methods applied in QSAR and new QSAR techniques, such as HQSAR and G-QSAR. Containing real-world examples that illustrate important methodologies, this book identifies QSAR as a valuable tool for many different applications, including drug discovery, predictive toxicology and risk assessment. Written in a straightforward and engaging manner, this is the ideal resource for all those looking for general and practical knowledge of QSAR methods. Includes numerous practical examples related to QSAR methods and applications Follows the Organization for Economic Co-operation and Development principles for QSAR model development Discusses related techniques such as structure-based design and the combination of structure- and ligand-based design tools

Author: Sarwar Beg
Publisher: Academic Press
ISBN: 0128163720
Category : Business & Economics
Languages : en
Pages : 448

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Book Description
Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers Includes contributions from global leaders and experts from academia, industry and regulatory agencies