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Category: General Published: 11 November 2009
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Scientifc at work

Scientist-At-Work

  • Office of Technology Assessment. Pharmaceutical R And D: Costs, Risks And Rewards

    Posted on: 7 August 2014, 8:56 am

    Book cover Office of Technology Assessment. Pharmaceutical R And D: Costs, Risks And Rewards

    Pharmaceutical costs are among the fastest growing components of health care costs today. Although increases in the inflation-adjusted prices of ethical drugs and perceived high prices of new drugs have been a concern of congressional committees for over 30 years, the growing Federal role in paying for prescription drugs has increased the concern over the appropriateness of prices relative to the costs of bringing new drugs to market. Specific policies of U.S. and other governments can alter the delicate balance between costs and returns to pharmaceutical R&D. with ramifications for the future health of Americans, for health care costs, and for the future of the U.S. pharmaceutical industry.OTA's report focuses mainly on the economic side of the R&D process. Pharmaceutical R&D is an investment, and the principal characteristic of an investment is that money is spent today in the hopes of generating even more money in the future. Pharmaceutical R&D is a risky investment: therefore, high financial returns are necessary to induce companies to invest in researching new chemical entities. Changes in Federal policy that affect the cost, uncertainty and returns of pharmaceutical R&D may have dramatic effects on the investment patterns of the industry. Given this sensitivity to policy changes, careful consideration of the effects on R&D is needed.

    Download Link:

    http://bookzz.org/dl/463991/a99b35

  • Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers

    Posted on: 25 June 2014, 10:26 am

    Book cover Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers

    Guy Wingate

    One of the biggest computer validation challenges facing pharmaceutical manufacturers is the large corporate system. This book provides practical information and advice on good IT practice and validation principles. Written by experts, it includes case studies on EDMSs, EAM systems, LIMSs, and MRP II systems.

    Year: 2000

    Edition: 1

    Language: English

    Pages: 547

    http://bookzz.org/dl/568488/6b98fa

  • International IT Regulations and Compliance: Quality Standards in the Pharmaceutical and Regulated Industries

    Posted on: 25 June 2014, 10:21 am

    Book cover International IT Regulations and Compliance: Quality Standards in the Pharmaceutical and Regulated Industries

    Siri H. Segalstad

    Standards, technologies, and requirements for computer validation have changed dramatically in recent years, and so have the interpretation of the standards and the understanding of the processes involved. International IT Regulations and Compliance brings together current thinking on the implementation of standards and regulations in relation to IT for a wide variety of industries. The book provides professionals in pharmaceutical and semiconductor industries with an updated overview of requirements for handling IT systems according to various Quality Standards and how to ?translate? these requirements in the regulations.

    Year: 2008

    Edition: 1

    Language: English

    Pages: 339

    http://bookzz.org/dl/564390/bc0dd6

  • Handbook Of Stability Testing In Pharmaceutical Development

    Posted on: 25 June 2014, 10:20 am

    Book cover Handbook Of Stability Testing In Pharmaceutical Development

    Kim Huynh-Ba

    Stability testing is required to demonstrate that a pharmaceutical product meets its acceptance criteria throughout its shelf life and to gain regulatory approval for commercialization. Assessing drug product stability and safety can be quite complicated, and stability profile can impact many functional areas, including analytical testing, formulation development, toxicology, quality, and regulatory affairs.

    Year: 2008

    Edition: 1

    Language: English

    Pages: 390

    http://bookzz.org/dl/563902/37223b

  • Good Design Practices for GMP Pharmaceutical Facilities

    Posted on: 25 June 2014, 10:19 am

    Book cover Good Design Practices for GMP Pharmaceutical Facilities

    Andrew Signore, Terry Jacobs

    A convenient single-source reference for anyone involved in the planning, construction, validation, and maintenance of modern pharmaceutical facilities, this guide assists project managers as they develop, diagram, and implement pharmaceutical production facility projects-demonstrating how advances in technology and external regulation can impact the production and efficacy of a pharmaceutical facility and the products it produces.

    Year: 2005

    Edition: 1

    Language: English

    Pages: 578

    http://bookzz.org/dl/563697/97e4a8

  • Encyclopedia of Pharmaceutical Technology

    Posted on: 25 June 2014, 10:18 am

    Book cover Encyclopedia of Pharmaceutical Technology

    Swarbrick J., Boylan J. C.

    This supplement to the Second Edition of the Encyclopedia of Pharmaceutical Technology heralds transformations and advances in the design, development, manufacture, testing, and regulation of pharmaceuticals-supplying over 40 expert-authored articles as well as nearly 1900 new references to groundbreaking research studies.

    Part: volume 20

    Year: 2001

    Language: English

    Pages: 335

    http://bookzz.org/dl/563234/2fb02f

  • Compact Regs Parts 210 and 211: CFR 21 Parts 210 and 211 Pharmaceutical and Bulk Chemical GMPs

    Posted on: 25 June 2014, 10:17 am

    Book cover Compact Regs Parts 210 and 211: CFR 21 Parts 210 and 211 Pharmaceutical and Bulk Chemical GMPs

    Food and Drug Administration

    The Compact Regs series provides full-text, pocket-sized format (3 3/4 inch x 5 1/2 inch) verbatim reproductions of key US FDA regulations. The texts are complete and have not been altered in any manner from the original sources. They are the perfect low-cost tools for: employees as part of documented GMP training programs, for suppliers/vendors so that they may provide components, labels, and parts with an understanding of FDA requirements, and for each clinical investigator, nurse, and technician to help assure compliance to clinical trial protocols. A keyword index can be found at the end of each booklet.

    Year: 2002

    Edition: 1

    Language: English

    Pages: 106

    http://bookzz.org/dl/562544/d914e6

  • 21 CFR 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

    Posted on: 25 June 2014, 10:15 am

    Book cover 21 CFR 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

    Orlando Lopez

    This guide delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with FDA regulations related to international computer validation in the pharmaceutical industry. The guide shows how to comply with computer systems validation requirements, while highlighting and integrating Part 11 requirements into the entire computer validation program. Regulatory compliance is placed within the context of quality assurance, and the importance of integrating validation into the system life cycle using a structured top-down approach is stressed. Information is applicable to computer systems for pharmaceuticals, cosmetics, food, and medical device applications.

    Year: 2004

    Edition: 1

    Language: English

    Pages: 287

    http://bookzz.org/dl/560842/d4d4d5

  • HPLC for Pharmaceutical Scientists

    Posted on: 25 June 2014, 10:15 am

    Book cover HPLC for Pharmaceutical Scientists

    Yuri V. Kazakevich, Rosario LoBrutto

    HPLC for Pharmaceutical Scientists is an excellent book for both novice and experienced pharmaceutical chemists who regularly use HPLC as an analytical tool to solve challenging problems in the pharmaceutical industry. It provides a unified approach to HPLC with an equal and balanced treatment of the theory and practice of HPLC in the pharmaceutical industry.
    In-depth discussion of retention processes, modern HPLC separation theory, properties of stationary phases and columns are well blended with the practical aspects of fast and effective method development and method validation. Practical and pragmatic approaches and actual examples of effective development of selective and rugged HPLC methods from a physico-chemical point of view are provided.
    This book elucidates the role of HPLC throughout the entire drug development process from drug candidate inception to marketed drug product and gives detailed specifics of HPLC application in each stage of drug development.
    The latest advancements and trends in hyphenated and specialized HPLC techniques (LC-MS, LC-NMR, Preparative HPLC, High temperature HPLC, high pressure liquid chromatography) are also discussed.

    Year: 2007

    Edition: 1

    Language: English

    Pages: 1135

    http://bookzz.org/dl/550619/e92e57

  • Pharmaceutical Analysis: A Textbook for Pharmacy Students and Pharmaceutical Chemists

    Posted on: 25 June 2014, 10:13 am

    Book cover Pharmaceutical Analysis: A Textbook for Pharmacy Students and Pharmaceutical Chemists

    David G. Watson BSc PhD PGCE

    Pharmaceutical Analysis: A Textbook for Pharmacy Students and Pharmaceutical Chemists highlights the most important aspects of a wide range of techniques used in the control of the quality of pharmaceuticals, including spectroscopy, chromatography, and electrophoresis. This clear, practical guide also includes self-testing sections and arithmetical examples and tests to help students brush up on their arithmetical skills in an applied context.

    Part: Volume 4

    Year: 1999

    Language: English

    Pages: 338

    http://bookzz.org/dl/509823/7bd27b

  • Office of Technology Assessment. Pharmaceutical R And D: Costs, Risks And Rewards

    Posted on: 25 June 2014, 10:12 am

    Book cover Office of Technology Assessment. Pharmaceutical R And D: Costs, Risks And Rewards

    Pharmaceutical costs are among the fastest growing components of health care costs today. Although increases in the inflation-adjusted prices of ethical drugs and perceived high prices of new drugs have been a concern of congressional committees for over 30 years, the growing Federal role in paying for prescription drugs has increased the concern over the appropriateness of prices relative to the costs of bringing new drugs to market. Specific policies of U.S. and other governments can alter the delicate balance between costs and returns to pharmaceutical R&D. with ramifications for the future health of Americans, for health care costs, and for the future of the U.S. pharmaceutical industry.OTA's report focuses mainly on the economic side.

    Year: 2005

    Language: English

    Pages: 359

    http://bookzz.org/dl/463991/a99b35

  • Enzyme Technologies for Pharmaceutical and Biotechnological Applications

    Posted on: 25 June 2014, 10:10 am

    Book cover Enzyme Technologies for Pharmaceutical and Biotechnological Applications

    Herbert Kirst, Wu-Kuang Yeh

    This reference provides a review of enzyme functions in human and animal health. It covers basic principles and applications in antibiotic biosynthesis, biocatalysis, and screening and assay optimization, as well as new and emerging technologies in the biotechnological and pharmaceutical industries. Emphasizing modern methods of metabolic engineering and drug discovery processes, the book details enzyme targets related to human disease. It also discusses effective enzymatic assays, high-throughput screening, novel compounds for lead generation, improvements in antibiotic yield, and the generation of contemporary protein products.

    Year: 2001

    Edition: 1

    Language: English

    Pages: 628

    http://bookzz.org/dl/462417/99e137

  • Thermodynamics of Pharmaceutical Systems: An Introduction for Students of Pharmacy

    Posted on: 25 June 2014, 10:09 am

    Book cover Thermodynamics of Pharmaceutical Systems: An Introduction for Students of Pharmacy

    Kenneth A. Connors

    Studies of thermodynamics often fail to demonstrate how the mathematical intricacies of the subject relate to practical laboratory applications. Thermodynamics of Pharmaceutical Systems makes these connections clear, emphasizing specific applications to pharmaceutical systems in a study created specifically for contemporary curriculums at colleges of pharmacy.Students investigating drug discovery, drug delivery, and drug action will benefit from Kenneth Connors's authoritative treatment of the fundamentals of thermodynamics as well as his attention to drug molecules and experimental considerations. An extensive appendix that reviews the mathematics needed to master the pharmacy curriculum proves an invaluable reference. Connors divides his one-of-a-kind text into three sections: Basic Thermodynamics, Thermodynamics of Physical Processes, and Thermodynamics of Chemical Processes; chapters include: * Energy and the First Law of Thermodynamics * The Entropy Concept * Phase Transformations * Solubility * Acid-Base Equilibria * Noncovalent Binding EquilibriaThermodynamics need not be a mystery nor be confined to the realm of mathematical theory. Thermodynamics of Pharmaceutical Systems introduces students of pharmacy to the profound thermodynamic applications in the laboratory while also serving as a handy resource for practicing researchers.

    Year: 2002

    Language: English

    Pages: 346

    http://bookzz.org/dl/459910/14dc4b

  • Australian Pharmaceutical Formulary and Handbook

    Posted on: 25 June 2014, 10:07 am
  • Guidelines for Chemical Reactivity Evaluation and Application to Process Design

    Posted on: 25 June 2014, 10:05 am

    Book cover Guidelines for Chemical Reactivity Evaluation and Application to Process Design

    Center for Chemical Process Safety (CCPS)

    Drawn from international sources, this book provides principles and strategies for the evaluation of chemical reactions, and for using this information in process design and management. A useful resource for engineers who design, start-up, operate, and manage chemical and petrochemical plants, the book places special emphasis on the use of state-of-the-art technology in theory, testing methods, and applications in design and operations.

    Year: 1995

    Language: English

    Pages: 247

    http://bookzz.org/dl/552497/15238d

  • Research and Development Management in the Chemical and Pharmaceutical Industry

    Posted on: 25 June 2014, 10:04 am

    Book cover Research and Development Management in the Chemical and Pharmaceutical Industry

    Peter Bamfield

    Mastering management skills is hard to achieve by newcomers starting their careers in the chemical industry. The message coming from there is that good chemists swiftly have to become good managers if they are to survive and progress in today's competitive climate.This book is designed to help guide younger R & D chemists to ways in which they can quickly evolve skills which are built around three factors-people, knowledge and time. It covers the management of scientific personnel, management within a variety of R & D organisational structures, creating a climate of innovation, the management of projects including the time management and communication aspects of the job.The author, Peter Bamfield, is now working as a consultant. Due to his long experience in the chemical industry, he was elected President of the Royal Society of Chemistry's Industrial Affairs Division.This second edition of the book has been revised and updated to take recent global developments and restructuring in the chemical industry into account, as well as the rising importance of information technology in management.

    Year: 2003

    Edition: 2

    Language: English

    Pages: 280

    http://bookzz.org/dl/566819/703838

  • DOE handbook. Chemical management

    Posted on: 25 June 2014, 10:02 am
  • The chemical laboratory: its design and operation: a practical guide for planners of industrial, medical, or educational facilities

    Posted on: 25 June 2014, 10:01 am

    Book cover The chemical laboratory: its design and operation: a practical guide for planners of industrial, medical, or educational facilities

    Sigurd Rosenlund

    Offers assistance to those involved in planning new laboratories, or expanding existing facilities. Emphasis throughout is on finding economical solutions without sacrificing quality.

    http://bookzz.org/dl/594535/51f4b0

  • Research and Development Management in the Chemical and Pharmaceutical Industry, Second Edition

    Posted on: 25 June 2014, 9:50 am

    Book cover Research and Development Management in the Chemical and Pharmaceutical Industry, Second Edition

    Dr. Peter Bamfield(auth.)

    Year: 2003

    Language: English

    Pages: 270

    http://bookzz.org/dl/2155748/5bcad2

  • Multi-Plant Safety and Security Management in the Chemical and Process Industries

    Posted on: 25 June 2014, 9:49 am

    Book cover Multi-Plant Safety and Security Management in the Chemical and Process Industries

    Genserik L.L. Reniers

    Year: 2010

    Edition: 1

    Language: English

    http://bookzz.org/dl/1089878/7ec9fa

  • Framework for Chemical Risk Management under REACH

    Posted on: 25 June 2014, 9:48 am
  • The Management of Chemical Process Development in the Pharmaceutical Industry

    Posted on: 25 June 2014, 9:46 am

    Book cover The Management of Chemical Process Development in the Pharmaceutical Industry

    Derek Walker

    Here is a practical guide that not only presents insights into the organization and management of the disciplines involved in chemical process development but also provides basic knowledge of these disciplines, enabling process development practitioners to recognize and assimilate them in their work. This book illustrates practical considerations through many examples of the successful direction and integration of the activities of chemists, analysts, chemical engineers, and biologists, as well as safety, regulatory, and environmental professionals in productive teams. Moreover, this reference provides guidance on:Directing and carrying out specific tasks and courses of actionMaking and communicating clear and achievable decisionsSolving problems on the spotManaging the administrative aspects of chemical process developmentThe author, Dr. Derek Walker, has directed chemical process development work for four decades, combining firsthand chemical synthesis experience with many other disciplines needed to create chemical processes. You will benefit from his advice and unique insights into:Understanding the workings of matrix organizationsDefining missions and creating action plansDeveloping interdisciplinary approaches to problem solvingHolding review meetings, revising goals, and motivating staffPrioritizing programs and responses to emergenciesIn addition, you'll learn how successful chemists, in collaboration with other disciplines, define the best (green) chemistry for process scale-up, including accommodating FDA requirements in the last process steps and addressing safety and environmental matters early in their work. Case studies provide incisive perspective on these issues. A chapter on recognizing and patenting intellectual property emphasizes the importance of comprehensive literature surveys and understanding invention. A chapter on the future challenges you to think beyond narrow constraints and explore new horizons.

    Year: 2003

    Edition: 1

    Language: English

    Pages: 416

    http://bookzz.org/dl/832541/27e009

  • Operational Risk Management: A Case Study Approach to Effective Planning and Response

    Posted on: 25 June 2014, 9:43 am

    Book cover Operational Risk Management: A Case Study Approach to Effective Planning and Response

    Mark D. Abkowitz

    Operational Risk Management offers peace of mind to business and government leaders who want their organizations to be ready for any contingency, no matter how extreme. This invaluable book is a preparatory resource for when times are good, and an emergency reference when times are bad. Operational Risk Management is destined to become every risk manager?s ultimate weapon to help his or her organization survive ? no matter what.

    Year: 2005

    Edition: 1

    Language: English

    Pages: 278

    http://bookzz.org/dl/859762/a1e471

  • Guidelines for Integrating Process Safety Management, Environment, Safety, Health, and Quality (Center for Chemical Process Safety (Ccps).)

    Posted on: 25 June 2014, 9:41 am

    Center for Chemical Process Safety (CCPS)

    Over the years, companies have developed independent systems for managing process safety, environment, health, safety, and quality. Many aspects of these management systems are similar. Integrating EHS management systems can yield economies and improved system effectiveness. This book explains how integration reduces cost of delivery through a reduction in the number of management program steps and avoidance of redundancy; how it results in more effective programs, since the best practices can be combined into a single process; and how this integration brings a faster, and more cost effective response to new demands.

    Year: 1996

    Language: English

    Pages: 192

    http://bookzz.org/dl/909189/d5a3a2


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    xahoihoctap.NET
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    About: Teaching resource - the 1st Vietnamse Portal in Metallurgy and Materials Technology. Cổng thông tin về lĩnh vực luyện kim và kỹ thuật vật liệu. Lĩnh vực chủ chốt: gang trắng Cr cao, thiêu kết xung điện plasma, xử lý nhiệt, tự động hóa trong luyện kim, luyện kim phi coke, động học hoàn nguyên Oxit sắt.

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