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Principles and Practice of Clinical Trial Medicine

Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, this book covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results.

*Jargon-free writing style enables those with less experience to run their own clinical trials and interpret data.
*Book contains an ideal mix of theory and practice so researchers will understand both the rationale and logistics to clinical trial medicine.
*Expert authorship whose experience includes running clinical trials in an academic as well as industry settings.
*Numerous illustrations reinforce and elucidate key concepts and add to the book's overall pedagogy.


Pharmaceutical Technology. Controlled Drug Release, Volume 2

Extends the concepts of Volume 1 to include drug properties, design and optimization, coating and the effect of food and pharmacokinetics. This volume also reflects the growing interest in biodegradable polymers in oral and topical formulations.


British National Formulary 56

Compiled with the advice of clinical experts, the British National Formulary (BNF) provides up-to-date guidance on prescribing, dispensing and administering medicines.

The BNF details medicines prescribed in the UK, with special reference to their uses, cautions, contra-indications, side-effects, dosage and relative costs.

Updated every six months, the BNF reflects current best practice as well as legal and professional guidelines relating to the use of medicines. It is intended for use by prescribers, pharmacists and other healthcare professionals.

  • Designed for rapid reference
  • Authoritative, impartial and, where available, evidence-based advice on prescribing, dispensing and administering medicines
  • Updated twice a year to reflect promptly changes in product availability as well as emerging safety concerns and shifts in clinical practice

Pharmaceutical Design And Development: A Molecular Biology Approach

This volume aims to introduce researchers in pharmaceutical and allied industries to the concepts and latest developments in the application of biotechnology recombinant DNA and monoclonal antibodies to drug development. The author puts biotechnology in perspective, introducing the basic concepts of cell and molecular biology and discussing both the application of protein drugs and the design of new molecular entities. The study examines the use of proteins and assay systems produced via biotechnology to the development of small-molecule drugs. A discussion of gene and somatic cell therapies is included, along with developments in diagnostic methods resulting from biotechnology. The text concludes by examining future prospects and likely developments in the field.

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Managing Pharmacy Practice: Principles, Strategies, and Systems

The myriad changes in health care and health care delivery have transformed the pharmacist's role within those systems. Reflecting these changes, Managing Pharmacy Practice: Principles, Strategies, and Systems delineates the managerial issues pharmacists face today and those that they will face in the future. Highlighting the growing impact of technology throughout pharmacy and healthcare, the book underlines the challenges of this rapidly evolving profession and explores strategies for success. Touching on basic management theory and thoroughly discussing systems theory, the text supplies the groundwork for analyzing managerial systems. This systems approach will allow the reader to understand the contextual relationships between seemingly disparate concepts. For example, the discussion of professionals and their role in society is juxtaposed with discussions of organizational designs and power. With contributions from leaders in fields as diverse as pharmacy, human resources, education, and management writing about their experiences, the book presents a broad overview of the complexities and intricacies inherent in managing systems in pharmacy.


Microbiological Assay for Pharmaceutical Analysis: A Rational Approach

A user-friendly guide for the evaluation of microbiological assays, Microbiological Assay for Pharmaceutical Analysis: A Rational Approach provides a lucid explanation of the sources of error in microbiological assay and helps analysts choose efficient assay designs that will minimize those sources of error. Beginning with a review of the theoretical basis for the quantitative aspects, the author discusses microbiological assay as a branch of pharmaceutical analysis and distinguishes it from biological assay in general. He draws attention to the microbiological aspects that may not be so obvious to the chemical analyst and to the analytical aspects that may not be so obvious to the microbiologist. The book contains detailed evaluations of assays that illustrate typical experimental designs and addresses how to present a realistic assessment of the best potency estimate from a series of assays. Although there are other valuable books available in this area, they do not address evaluation. Microbiological Assay for Pharmaceutical Analysis: A Rational Approach expands on the guidance given in pharmacopoeias and helps you choose the assay design most appropriate for the purpose of your assay.


Handbook of Pharmaceutical Manufacturing Formulations: Semisolids Products

The fourth volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers semi-solid drugs. It includes formulations of ointments, lotions, gels, and suppositories, from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and other sources of generic and proprietary formulations. Each entry begins with a fully validated scaleable manufacturing formula and a summary of manufacturing process. The book provides a detailed discussion on the difficulties encountered in manufacturing semi-solid drugs, the common elements of formulations. The section on regulatory and manufacturing guidance deals with such topics as changes to approved NDAs and aNDAs, post-approval changes to semisolid drugs, SUPAC for non-sterile semisolid dosage form equipment, stability testing of drugs substances and drug products, guidelines on evaluation of stability data in retest periods, skin irritation and sensitization testing of generic transdermal products, and photosafety testing, in addition to providing quick tips on resolving the common problems in formulating semisolid products.


Pharmaceutical Packaging Technology

Pharmaceutical packaging is regarded as an integral part of the end pharmaceutical/drug product. Pharmaceutical Packaging Technology is structured to meet the needs of the global market, and assesses a wide range of current knowledge, catering for the requirements of the pharmaceutical industry as well as for pharmaceutical companies in emerging nations who are still seeking a basic grounding in the subject. The author integrates information on many drug delivery systems, where the packaging is an essential component of the product, to produce a book for all those dealing with the topic.


NMR Spectroscopy in Pharmaceutical Analysis

For almost a decade, quantitative NMR spectroscopy (qNMR) has been established as valuable tool in drug analysis. In all disciplines, i. e. drug identification, impurity profiling and assay, qNMR can be utilized.
Separation techniques such as high performance liquid chromatography, gas chromatography, super fluid chromatography and capillary electrophoresis techniques, govern the purity evaluation of drugs. However, these techniques are not always able to solve the analytical problems often resulting in insufficient methods. Nevertheless such methods find their way into international pharmacopoeias. Thus, the aim of the book is to describe the possibilities of qNMR in pharmaceutical analysis.
Beside the introduction to the physical fundamentals and techniques the principles of the application in drug analysis are described: quality evaluation of drugs, polymer characterization, natural products and corresponding reference compounds, metabolism, and solid phase NMR spectroscopy for the characterization drug substances, e.g. the water content, polymorphism, and drug formulations, e.g. tablets, powders. This part is accompanied by more special chapters dealing with representative examples. They give more detailed information by means of concrete examples. combines theory, techniques, and concrete applicationsall of which closely resemble the laboratory experience considers international pharmacopoeias, addressing the concern for licensing features the work of academics and researchers, appealing to a broad readership.


Modified-Release Drug Delivery Technology

Describing formulation challenges and their solutions in the design, development, and commercialization of modified-release drugs delivery systems, this book contains eighty papers that review recent developments in design and manufacturing techniques. It includes detailed descriptions of extended release drug products for the oral, nasal, ophthalmic, pulmonary, vaginal, dermal and transdermal pathways. With the exception of the final section addressing regulatory issues, each section covers a particular route for drug delivery and opens with an overview of the anatomical, physiological, and pharmaceutical basics of each route before moving on to cover specific technologies.


Goodman & Gilman's The Pharmacological Basis of Therapeutics

The undisputed leader in medical pharmacology, without equal. Updated to reflect all critical new developments in drug action and drug-disease interaction. This is the “desert island” book of all medical pharmacology—if you can own just one pharmacology book, this is it.


Achieving Sterility in Medical and Pharmaceutical Products

Detailing the scientific principles underlying the achievement of sterility, this unique reference examines both a broad spectrum of practical, commonly used sterilization procedures and the methods available to confirm sterility-assessing the strengths and limitations of each technology. Delineates current regulatory requirements for sterility-emphasizing the importance of aseptic processes in the medical establishment and the pharmaceutical industry! Achieving Sterility in Medical and Pharmaceutical Products discusses sterilization approaches that utilize · saturated steam · dry heat · ethylene oxide · gamma radiation · sterile filtration · and more!


Designing Clinical Research: An Epidemiologic Approach

Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This edition incorporates current research methodology--including molecular and genetic clinical research--and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing. All chapters have been thoroughly revised, updated, and made more user-friendly.


Pharmaceutical Care Practice: The Clinician's Guide

The most practical approach to pharmaceutical care! Provides all the principles and practice components for the pharmaceutical care practice course in the pharmacy curriculum. Thoroughly revised and updated, this edition includes expanded coverage of reimbursement, documentation, and data models associated with the practice.


Pharmacotherapy Handbook

The second edition of the Pharmacotherapy Handbook provides readers with a portable, readable guide that is integral to any clinical setting. Bold-face type highlights drug names when they first appear and in all closing information. The book's bulleted format helps readers find the information they need immediately. This updated book was designed as a companion text for the fourth edition Pharmacotherapy: A Pathophysiologic Approach.


Principles and Practice of Clinical Research, Second Edition

The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.

*Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research

*Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research

*Delves into data management and addresses how to collect data and use it for discovery

*Contains valuable, up-to-date information on how to obtain funding from the federal government

Antisense Drug Technology: Principles, Strategies, and Applications

This state-of-the-art reference provides comprehensive coverage of the development of antisense oligonucleotides to inhibit cancer cells as well as those involved in infectious, inflammatory, and immune-mediated diseases-highlighting new tools and technologies in medicinal chemistry, RNA biochemistry, and molecular and cellular biology to produce new therapeutic compounds. Presents previously unpublished data on the use of antisense technology to dissect pharmacological processes and confirm the roles of various genes! Showcasing the benefits of antisense drug use, including reduced toxicity and earlier disease detection, Antisense Drug Technology discusses · novel formulations of antisense drugs · practical methods to design effective isotype selective inhibitors · molecular mechanisms of antisense drugs · mRNA as a current biological template · modern postreceptor binding mechanisms · and more! With contributions by over 60 seasoned experts in the field and containing more than 3000 helpful references, tables, drawings, and photographs, Antisense Drug Technology is an illuminating source for organic, medicinal, and pharmaceutical chemists; biochemists; geneticists; hematologists; oncologists; molecular and cell biologists; virologists; immunologists; and medical school and graduate students in these disciplines.


Regulatory Focus - September 2008

Where is our profession headed?

A Seat at the Table:Regulatory in Corporate Health care

Managing Global Business Risk:The New Role of Regulatory Leaders

Mergers, Acquisitions and Operational Risk

The Regulatory Professional:A Jack of All Trades

Regulating Nanotechnology in the US & EU


Liposome Technology, Volume I: Liposome Preparation and Related Techniques, Third Edition

Liposome Technology, Volume I: Liposome Preparation and Related Techniques, Third Edition, is a thoroughly updated and expanded new edition of a classic text in the field. Including step-by-step technical details, Volume I illustrates numerous methods for liposome preparation and auxiliary techniques necessary for the stabilization and characterization of liposomes. This source also offers critical discussions of the methodologies of each technology described so that readers can examine the benefits and limitations and compare it to other approaches.


Liposome Technology, Volume II: Entrapment of Drugs and Other Materials into Liposomes, Third Edition

Liposome Technology, Volume II: Entrapment of Drugs and Other Materials into Liposomes, Third Edition is a comprehensively updated and expanded new edition of a classic text in the field. Including step-by-step technical details, Volume II describes procedures for the incorporation of drugs and other materials into liposomes for a variety therapeutics, chosen because of their relevance to current trends in liposome applications or because they represent groups of active pharmaceutical ingredients with similar physical and chemical properties. This source also offers critical discussions of the methodologies of each technology described so that readers can examine the benefits and limitations and compare it to other approaches.


Foundations of Pharmacokinetics

This book is divided into two parts; in the first part the principles and the methods of pharmacokinetics are described in detail, while in the second the main pharmacokinetic parameters are described, giving for each of them the definition, the principal properties, and the methods of determination. An appendix contains the important mathematical instruments used in the main part of the book, namely the operational calculus and the convolution integral.

The first part begins with the definition of pharmacokinetics, then continues with the description of the experimental method as applied to the modeling of pharmacokinetic systems. The bulk of this part is the description of the first compartmental models used in the '30's, the more modern compartmental equations developed later, the integral equations and the matrix equations.

In the second part there is a careful distinction among pharmacokinetic parameters, i.e., parameters that represent a true pharmacokinetic property, model parameters, i.e., parameters that represent a property of a specific model, and incidental parameters, i.e., parameters that represent only the result of a particular experiment. Special care is taken to distinguish between the definition of a parameter, and the properties that derive from that definition; a considerable emphasis is also given to the fact that each method for the determination of a parameter is dependent on the specific model it is based on.


A Practical Guide to Quality Management in Clinical Trial Research

Setting up a GXP environment where none existed previously is a very daunting task. Getting staff to write down what they do for every task is a correspondingly difficult and time-consuming exercise. Examining how to maintain quality control in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides a cornerstone of knowledge for establishing a quality system that complies with the relevant regulations. There are many books available that cover how to interpret regulations. Going a step or two further, this book provides practical advice that is useful on a daily basis. The book contains information for various standards including GLPs, GCPs, and GMPs. It gives detailed explanations of how to prepare, update, and maintain SOPs and includes advice on training and development of personnel. Drawing directly on his years of experience, the author delineates a from-the-trenches methodology that creates a value-added quality management system from a business perspective. He provides a solid foundation as well as tips and techniques for establishing a quality system that will comply with all the relevant regulations. The author's integrated approach and anecdotal style turns technically accurate information into easy reading. The book arms you with tools and concepts that you can use to go beyond regulatory compliance and move into the realm of business quality improvement.


Wiley Guide to Chemical Incompatibilities

The Second Edition of the Wiley Guide to Chemical Incompatibilities provides chemists, technicians, and engineers with a thorough, lightening-quick resource to use during experimental preparation and in the event of an emergency. Includes:
  • Hard-to-find data on over 11,000 chemical compounds
  • 2,000 more chemical listings than the First Edition
  • Alphabetical organization providing concise incompatibility profiles for thousands of commonly used commercial chemcials
  • CAS Numbers to eliminate confusion among similar synonym names.
  • A glossary of general chemical terms
This expanded Second Edition, set out in a convenient, easy-to-use format, is an essential guide for all safety, first-response, and plant management professionals working with chemical materials.


Clarke's Analysis of Drugs and Poisons, Third Edition

This practical manual and standard reference work provides an authoritative source of analytical data for drugs and poisons. It is intended for use primarily by scientists faced with identifying and quantifying these substances in body fluids, tissue samples and pharmaceutical and industrial products. This completely revised and updated new edition now comprises two volumes housed in a handy slipcase. Clarke's Analysis of Drugs and Poisons is an essential requirement for all forensic and crime laboratories, toxicologists, clinical pharmacology departments, poison information centres, pathologists, clinical toxicologists, hospital pharmacists and analytical chemists. Clarke's Analysis of Drugs and Poisons was previously published as Clarke's Analysis and Identification of Drugs.


Herb Navigator-Materia Medica

User friendly revolutionary program that will allow you quickly and easily improve the accuracy of your clinical observations, diag- nosis and herbal prescriptions.

With a few clicks of the mouse, you can quickly and easily see more clearly the possibilities and best use of interconnected formulas, conditions, and actions.

  • Over 140 herbs and over 400 specific ailments are referenced
  • Search by indication
  • Unique search by multiple actions
  • The program offers you the ability to add your own data.
  • Preparation methods are given for each herb
  • Adult dosage ranges for all appropriate preparations are given


Liposome Technology, Volume III: Interactions of Liposomes with the Biological Milieu, Third Edition

Liposome Technology, Volume III: Interactions of Liposomes with the Biological Milieu, Third Edition, is a comprehensively updated and expanded new edition of a classic text in the field. Including step-by-step technical details, Volume III describes technologies for yielding liposomes that can function in a targeted fashion, and highlights methods for studying the interaction of liposomes within the biological environment to be applied in the detection, therapy, or prevention of disease. This source also offers critical discussions of the methodologies of each technology described so that readers can examine the benefits and limitations and compare it to other approaches.


Powder and Bulk Engineering International Sep/Oct-2008

Powder and Bulk Engineering International [ISSN 1098-6480] is pub -lished six times a year in January, March, May, July, September, and November by CSC Publishing, Inc., 1155 Northland Drive, St. Paul, MN 55120. After several years of not being published, Powder and Bulk Engineering International is back!


Basic criteria for selecting a bagging system Walter Kersting
Case History: FFS bagging adds flexibility at feed plant
Case History: Conveyor dryers increase capacity, ensure quality at
Thai Luxe
A preview of new products on display at POWTECH 2008
POWTECH 2008 exhibitor list


Industry news
Engineering literature: Bin Dischargers
Equipment feature: Bagging and Packaging
Equipment feature: Drying
Engineering literature: Rotary Airlocks
Product update
Supplier news
People news
Advertiser index

Integration of Pharmaceutical Discovery and Development: Case Histories

This volume provides case histories illustrating the types of interdisciplinary interactions necessary to design drug candidates with optimal pharmacological, pharmaceutical, biopharmaceutical, and metabolic/pharmacokinetic properties. Key features include an incisive discussion of HIV protease inhibitors and 287 illustration.


Supercritical Fluid Technology for Drug Product Development

Interconnecting the fundamentals of supercritical fluid (SCF) technologies, their current and anticipated utility in drug delivery, and process engineering advances from related methodological domains and pharmaceutical applications, this volume unlocks the potential of supercritical fluids to further the development of improved pharmaceutical products-from drug powders for respiratory delivery to drug delivery systems for controlled release.


Pharmaceutical Statistics: Practical and Clinical Applications, Fourth Edition, Revised and Expanded

The fourth edition of this text includes a disk with special programs to aid in problem analysis. The text presents fresh material on concept conformity and release targets and describes linear regression and correlation, the analysis of variance and crossover designs.


Handbook of Drug Metabolism

Bringing together nearly forty collaborators from academic and industrial laboratories, this reference furnishes an overview of the subject from a historical, kinetic, and chemical context. A source of expertise for a rapidly changing and expanding field, the book provides a framework for drug metabolism in drug discovery and development. Containing tables, drawings, photographs, and equations, it highlights the importance of pharmacokinetics and cytochrome P450, explains clearance, volume of distribution, sequential metabolism, and nonlinear kinetics, summarizes concepts of Phase 1 and 2 metabolites, evaluates tertiary amine metabolism and reactive metabolite chemistry, and more.


Medicinal Chemistry and Pharmacological Potential of Fullerenes and Carbon Nanotubes

Fullerenes and nanotubes are two classes of carbon structures or allotropes, which were discovered about 17 years ago. Since that time, many chemical derivatives have been synthesized using fullerenes and nanotubes as building blocks.

Particularly promising was the theory that the chemical properties of fullerenes, and certain derivatives, made them likely candidates for anticancer drugs, inhibitors of viruses such as HIV, or even as anti-bacterials. Their cyctotoxicity can also be controlled by specific circumstances.

In addition, the funtionalization of nanotubes has not only produced relatively simple derivatives, but also complex hybrids with biological macromolecules, which show unique supramolecular architecture and which are promising in many medical applications.

The application of fullerenes and nanotubes in medicine is at the frontier of our knowledge, thus the work in this field represents the basis for future novel developments.

Rapid Microbiological Methods in the Pharmaceutical Industry

In recent years there has been increased interest in the possibility of rapid microbiological methods offering enhanced potential error detection capabilities. However, these methods raise a number of questions, such as how to validate new methods, will they be accepted by the pharmacopoeias, and, most importantly, how will the regulators respond? Rapid Microbiological Methods in the Pharmaceutical Industry answers these questions and more. Martin Easter and his panel of experts: § Describe the range of rapid microbiological methods and their applications, including practical tips, and their status regarding validation, established use, and regulatory acceptance § Explore the origins of current methods and the current issues facing the requirements of microbiology and its associated test methods § Delineate the challenges involved in seeking better and more pragmatic methods for the assessment of microbial hazards and risks to ensure product and consumer safety The book assists you in applying an effective system to assess the real microbiological hazards and, hence, quantify realistic risks. Additionally, it provides monitoring methods that will deliver meaningful, useful data for effective decision making in manufacturing, quality assurance, and product safety. The expert and authoritative information in Rapid Microbiological Methods in the Pharmaceutical Industry will help you find better solutions to ensuring the microbiological safety of pharmaceutical products.


Topical Absorption of Dermatological Products

Contains current methods of analysis for new formulations of cosmetics, perfumes, creams, and lotions! With contributions from world-renowned experts in the field, Topical Absorption of Dermatological Products summarizes · novel treatments for fungal nail infections · emerging risk assessment procedures for sunscreen products · real-time breath analysis and physiologically based pharmacokinetic modeling (PBPK) for the examination of chemically exposed tissues · the use of micelles, mixed micelles, liposomes, and microemulsions as effective drug delivery systems · modern therapeutic devices for the management of acute, subacute, and chronic steroid-responsive dermatoses Providing state-of-the-art strategies for the control of irritation and infection, Topical Absorption of Dermatological Products is an in-depth source for dermatologists, pharmacists, pharmacologists, cosmetic scientists, biochemists, toxicologists, public health officials, manufacturers of cosmetics and toiletries, and upper-level undergraduate and graduate students in these disciplines.


Molecular Biology and Biotechnology

As a textbook, Molecular Biology and Biotechnology has always been immensely popular. Now in its fourth edition, it has been completely revised and updated to provide a comprehensive overview of the area, and to reflect all the latest developments. Written by recognised experts, each of the nineteen chapters describes a specific subject area relevant to the subject of biotechnology. The impressive breadth of coverage takes into account both molecular biology and industrial applications and aims to identify the impact that molecular biology has had on the development of biotechnology. Presenting information in an easily assimilated form, Molecular Biology and Biotechnology makes an ideal undergraduate text. It will be of particular interest to students of biology and chemistry, as well as to scientists from outside the field requiring a rapid introduction to the subject.


Pharmaceutical Engineering - July/August 2008

Table of Contents: Articles
Increased Process Understanding Through Monitoring and Scale-Down Models: Case Study of a Cell Culture Harvest Fluid Titration and Filtration Process
by Kurt Yanagimachi, Corey Dodge, and Marisa Hewitt
This article presents a case study demonstrating the use of detailed process monitoring and scale-down modeling in determining the root causes of yield losses in the manufacture of a therapeutic enzyme and identifying alternative technologies to improve the manufacturing process.
Case Study: Parenteral Facility Upgrade Project with Fill Line Install
by Keith Weseli and Michael DiGiovanni
This article presents a case study illustrating project management and commissioning and qualification processes that allowed for accelerated completion of a renovation project.
Integrating Industrial Engineering and Lean Techniques at a Contract Pharmaceutical Manufacturer
by Valerie Maier-Speredelozzi, Cyrus Agarabi, Thomas Needham, and Sirine A. Saleem
This article presents the application of industrial engineering and lean techniques to a contract pharmaceutical manufacturing facility.
Retrofitting CIP into API Plants
by Nigel A. Fletcher
This article describes the physical modifications and additions retrofitted into existing plants to incorporate CIP technology and some of the techniques that can be used to ‘stretch’ the existing CIP systems for best effect.
Solving the Terminology Conundrum
by Robert Adamson, Nuala Calnan, Robert E. Chew, and Steven J. Wisniewski
This article discusses the terms “commissioning,” “qualification,” and “verification.” Do the terms refer to the same or different ideas? How should the pharmaceutical and biotechnology industries use these terms in a consistent and meaningful way? This article provides a compilation of how these terms are used in regulations and by various industries, and provides a proposal for clear definitions to be used as ISPE updates and creates Baseline® Guides.


Peptide-Based Drug Design: Methods and Protocols

Due to their high specificity and low toxicity profile, peptides have once again become central to the development of new drugs. In Peptide-Based Drug Design: Methods and Protocols, expert researchers provide a handbook which offers a selection of research and production tools suitable for transforming a promising protein fragment or stand-alone native peptide into a pharmaceutically acceptable composition. The volume delves into contemporary, cutting-edge subjects such as hit isolation and target validation, computer-aided design, sequence modifications to satisfy pharmacologists, in vivo stability and imaging, and the actual production of difficult sequences. Written in the highly successful Methods in Molecular Biology™ series format, chapters include readily reproducible, step-by-step laboratory protocols, lists of materials, and the Notes section, which highlights tips on troubleshooting and avoiding known pitfalls. Comprehensive and up-to-date, Peptide-Based Drug Design: Methods and Protocols shows its subject to be an independent science on the rise, and provides scientists with a clear, concise guide for continuing this vital research.


Pharmaceutical Engineering - May/June 2008

Table of Contents


A Risk-Based Approach to Cleaning Validation using Visible Residue Limits
by Richard J. Forsyth and Jeffrey L. Hartman
This article describes the development of a Visible Residue Limits (VRL) program in a pharmaceutical manufacturing facility, including sample and viewing parameters. Opportunities for VRL implementation were identified in both pilot plant and manufacturing settings.
GAMP 5 Quality Risk Management Approach
by Kevin C. Martin and Dr. Arthur (Randy) Perez
This article describes how the GAMP 5 quality risk management strategy offers a pragmatic approach to computer systems compliance.

Creating Quality by Design/Process Analytical Technology (QbD/PAT) Management Awareness

by Christian Woelbeling and the Regional PAT COP from ISPE DACH Affiliate
This article summarizes the first four chapters of the PAT awareness document created by the PAT COP and explains how QbD/PAT management awareness can be created.
Industry Interview Series: Ruediger Dorn, Managing Director, Worldwide Pharmaceutical Industry, Microsoft
In this interview, Ruediger Dorn discusses Microsoft’s focus on the life sciences and the evolving relationship between plant operations and IT. Speaking from experience in auto manufacturing, he gives his thoughts on current challenges in the pharmaceutical industry.
Domain Methodology for Computer System Specification and Verification Applied to Manufacturing Execution Systems (MES)
by Joseph F. deSpautz and Gregory Ruklic
This article summarizes the domain methodology described in the GAMP® Good Practice Guide on Manufacturing Execution Systems currently under development.
Corrective Action Preventive Action (CAPA): A Risk Mitigating Quality System
by Gamal Amer
This article identifies ways to mitigate the risk associated with the manufacture of drug products.
On-line Exclusive Articles

Barrier Isolation History and Trends – 2006 Data
by Jack Lysfjord and Michael Porter
This article provides history and trends for automated fill finish for injectable drugs utilizing isolator technology.
GAMP 5 Debuts to a Record Breaking European Audience
by Gail Evans, ISPE Technical Documents Writer/Editor
Introduction to ICH: Essential Background to PQLI
by Dr. Kate E. McCormick, ISPE European Education Advisor
Global Regulatory News


The Aqueous Cleaning Handbook: A Guide to Critical-Cleaning Procedures, Techniques and Validation

This book distills and presents practical information covering the history of aqueous cleaners-- what they are, how they work, and how to make best use of them in cleaning products and components in electronics, metalworking, precision manufacturing, food-and-beverage, pharmaceutical, and chemical processing; and many other industrial applications.