Written by twenty-eight experts, filled with recommendations that can immediately be put into action, this book provides the strategies and tactics required to link and harmonize manufacturing processes with GMP to achieve optimum operability and cost-effective regulatory compliance. Drawn from name brand and generic companies and regulatory and contract organizations across the globe, the contributing authors bring readers a combined 450+ years of hands-on experience. They offer thought-provoking questions to help readers diagnose their company's challenges, needs, and available options, all with the single purpose of achieving their ultimate goals: quality, high productivity, and profitability.

This thoroughly authoritative work furnishes organizational, technological, validation, project management, and business perspectives on pharmaceutical information automation from industry and system automation professionals-demonstrating how to fulfill computer system validation requirements for hardware, applications, networks, data center operations, and complex software management practices in pharmaceutical manufacturing.
Explains how the Food and Drug Administration's latest Good Manufacturing Process guidelines supporting electronic identification and electronic signatures for batch record registration together with computer system technologies will influence pharmaceutical production automation
Designed to provide quick and easy access to a whole range of system development topics, Automation and Validation of Information in Pharmaceutical Processing
defines a complete life-cycle methodology that integrates equipment, people, and information
presents concepts, guidelines, test plans, example forms, and application details for previously unavailable computer system validation of complex automated information systems
introduces, for the first time in depth, PQ testing of integrated manufacturing execution (MES) and manufacturing resource planning (MRP) applications
describes how human resource programs maximize productivity gains for automation initiatives
discusses approaches to automating batch operations with process control systems using industry examples and applicable computer technology concepts
provides an outline for IQ, OQ, and PQ test plans for process control systems, including forms for use in testing instrumentation and distributed control system installation and operations
employs a business analysis standpoint on life-cycle planning to justify new automation projects, including multiyear drug manufacturing plans
documents the successful application of life-cycle methodologies to supply chain functions
and much more
Together with references, tables, and drawings, Automation and Validation of Information in Pharmaceutical Processing is an essential, hands-on resource for pharmaceutical scientists, manufacturers, and engineers; drug quality assurance and regulatory personnel; project and program manufacturers; information system professionals and software developers and analysts; information technology practitioners; and graduate-level and continuing-education students in these disciplines.

Written by the founders of the Institute of Validation, this practical introduction to validation cuts through all the jargon and focuses on the essentials. Whether you are a novice or an experienced validator, this book will help you understand validation fundamentals and ways in which these principles can be bonded with quality assurance, enabling you to build the highest quality into your products. Beginning with definitions of validation, the authors guide you through all the basics, associated costs, responsibilities, policies, strategies, support activities, SOPs, Master Plans, and other related subjects. Packed with tools to help you follow the logic of the validation process, the book covers testing, certification, protocols, final reports, sign-offs, ways to create seamless audit trails, and other topics impacting the qualification of a system, equipment, and/or process.

Employing a wide range of examples from G-protein-coupled receptors and ligand-gated ion channels, this detailed, single-source reference illustrates the principles of pharmacological analysis and receptor classification that are the basis of rational drug design.
Explains the experimental and theoretical methods used to characterize interactions between ligands and receptors-providing the pharmacological information needed to solve treatment problems and facilitate the drug design process
Demonstrating the achievements of the receptor-based approach in therapeutics and indicating future directions, Receptor-Based Drug Design
introduces novel computer-assisted strategies for the design of new agonists, antagonists, and inverse agonists for G-protein-coupled receptors
shows how to assess agonist concentration-effect curve data
discusses radioligand binding assays
presents new in vitro multiarray assays for G-protein-coupled receptors
explains the use of individual second messenger signaling responses in analyzing drug-receptor interactions
examines the role of electrophysiology in finding new drugs and drug targets
describes selectively acting b-adrenoceptor agonists and glucocorticoid steroids for asthma treatment
outlines the rationale for using angiotensin receptor antagonists
and more
Written by over 25 international authorities and containing nearly 1200 bibliographic citations, Receptor-Based Drug Design is a practical resource for pharmacologists, pharmacists, and pharmaceutical scientists; organic and medicinal chemists and biochemists; molecular biologists; biomedical researchers; and upper-level undergraduate and graduate students in these disciplines.

The Life-Cycle of Pharmaceuticals in the Environment identifies pathways of entry of pharmaceuticals into the environment, beginning with the role of global prescribing and disposal practices. The book then discusses typical levels of common pharmaceuticals and how they can be determined in natural waters such as raw and treated sewage, and in potable water. In addition, sections examine methods currently available to degrade pharmaceuticals in natural waters and some of their ecotoxicological impacts, along with future considerations and the growing concept of product stewardship.

Honey typically has a complex chemical and biochemical composition that invariably includes complex sugars, specific proteins, amino acids, phenols, vitamins, and rare minerals. It is reported to be beneficial in the treatment of various diseases, such as those affecting the respiratory, cardiovascular, gastrointestinal, and nervous systems, as well as diabetes mellitus and certain types of cancers; however, there is limited literature describing the use of honey in modern medicine. This book provides evidence-based information on the pharmaceutical potential of honey along with its therapeutic applications and precise mechanisms of action. It discusses in detail the phytochemistry and pharmacological properties of honey, highlighting the economic and culturally significant medicinal uses of honey and comprehensively reviewing the scientific research on the traditional uses, chemical composition, scientific validation, and general pharmacognostical characteristics. Given its scope, it is a valuable tool for researchers and scientists interested in drug discovery and the chemistry and pharmacology of honey.

This volume of Pharmacochemistry Library comprises the text of invited lectures presented at the 11th Noordwijkerhout-Camerino Symposium "Trends in Drug Research," held in Noordwijkerhout, The Netherlands, from 11-15 May 1997.

In the programme attention has been given to the generation of new biological target systems and the generation of new lead molecules, with presentations on e.g. combinatorial chemistry, compound libraries, database search, high throughput screening and molecular biology.

Other topics discussed were the perspectives for new medicines for the gastro-intestinal tract, the major developments in the search for effective anti-HIV drugs and new aspects in synthetic approaches. In a special session three topics which currently draw much attention were discussed: How to deal with the major problem of resistance against antimirobial agents? Can the apoptosis mechanism be used as a drug target? Is the newly observed phenomenon of inverse agonism a general principle and has it consequences for drug development (and use?)

More than a checklist of audit questions, this guidebook provides proven methods and techniques for performing effective audits that serve your department, your company, and you. Topics covered relate to the four key competencies essential for successful GMP audits. Includes the rationale for auditing as an important quality tool, along with the audit cycle, broken into five distinct phases. To focus the power of auditing on a particular situation, several different types of audits are presented, as are more than a dozen audit approaches with general questions to answer and specific items to examine. These tools will help you prepare checklists and standards so audits become more effective, consistent, and standardized. The book includes profiles of seasoned professionals in drug and device auditing, who share their experiences (the good and the bad)

Small structural modifications can significantly affect the pharmacokinetic properties of drug candidates. This book, written by a medicinal chemist for medicinal chemists, is a comprehensive guide to the pharmacokinetic impact of functional groups, the pharmacokinetic optimization of drug leads, and an exhaustive collection of pharmacokinetic data, arranged according to the structure of the drug, not its target or indication. The historical origins of most drug classes and general aspects of modern drug discovery and development are also discussed. The index contains all the drug names and synonyms to facilitate the location of any drug or functional group in the book. This compact working guide provides a wealth of information on the ways small structural modifications affect the pharmacokinetic properties of organic compounds, and offers plentiful, fact-based inspiration for the development of new drugs. This book is mainly aimed at medicinal chemists, but may also be of interest to graduate students in chemical or pharmaceutical sciences, preparing themselves for a job in the pharmaceutical industry, and to healthcare professionals in need of pharmacokinetic data.

Vaso-occlusive disorders including unstable angina, myocardial infarction, transient ischemic attacks, stroke and peripheral artery disease remain the major sources of morbidity and mortality in western civilization. Platelet activation and resulting platelet aggregation play a major role in the pathogenesis of these thromboembolic diseases. Recognition of the contribution of platelets to the pathophysiology of cardiovascular disease has provided impetus for the continued search for new antiplatelet agents. Hence, over the past two decades many strategies have been evaluated in the search for efficacious mechanisms to reduce platelet function. The medical need for more efficacious antithrombotic drugs and the growing understanding of the role of platelets in vascular injury have catalyzed the extensive evaluation of novel approaches to control platelet function. Along these lines, the volume therefore provides an in-depth assessment of ongoing clinical trials, new and clinically established agents, and other developments in this rapidly developing field.

Immunoassay development is a multidisciplinary activity involving a wide range of skills possessed by few laboratories. This presentation of tried and tested methods should enable scientists and researchers in the pharmaceutical and related industries to more rapidly and effectively develop immunoassays upon which their work is becoming heavily dependent.; Important methods are included for preparing Lapten-protein conjugates and raising the necessary antibodies, concentrating on polyclonal sera, as well as methods for the synthesis of radio and enzyme labelled tracers. Particular attention is paid to the requirements of the regulatory authorities such as the FDA (Food and Drug Administration) with respect to assay validation. Further chapters deal with assay development and optimization, curve fitting and quality control procedures.

Statistical Approaches in Oncology Clinical Development : Current Paradigm and Methodological Advancement presents an overview of statistical considerations in oncology clinical trials, both early and late phase of development. It illustrates how novel statistical methods can enrich the design and analysis of modern oncology trials. The authors include many relevant real life examples from the pharmaceutical industry and academia based on their first-hand experience. Along with relevant references, the book highlights current regulatory views. The book covers all aspects of cancer clinical trial starting from early phase development. The early part of the book covers novel phase I dose escalation design, exposure response analysis, and innovative phase II design. This includes early development strategy for cancer immunotherapy trials. The contributors also emphasized the role of biomarker and modern era of precision medicine. The second part focuses on the late stage development. This includes the application of adaptive design, safety analysis, and quality of life (QoL) data analysis. The final part discusses current regulatory perspective and challenges. Features: Covers a wide spectrum of topics related to real-life statistical challenges in oncology clinical trials. Provides a comprehensive overview of novel statistical methods to improve trial design and statistical analysis. Detailed case studies illustrate the real life applications. Satrajit Roychoudhury is a Senior Director and a member of the Statistical Research and Innovation group in Pfizer Inc. Prior to joining; he was a member of Statistical Methodology and consulting group in Novartis. He has 11 years of extensive experience in working with different phases of clinical trial. His area of research includes early phase oncology trials, survival analysis, model informed drug development, and use of Bayesian methods in clinical trials. He is industry co-chair for the ASA Biopharmaceutical Section Regulatory-Industry Workshop and has provided statistical training in major conferences including the Joint Statistical Meetings, ASA Biopharmaceutical Section Regulatory-Industry Workshop, and ICSA Applied Statistics Symposium. Soumi Lahiri has 12 years of extensive experience in working different therapeutic areas. She is the former Director of Biostatistics in Clinical Oncology, GlaxoSmithKline. She has also worked in the oncology division of Novartis Pharmaceutical Company for two years. She is an active member of the ASA Biopharmaceutical section and former chair of the membership committee.

"In Vitro" Methods in Pharmaceutical Research provides a comprehensive guide to laboratory techniques for evaluating "in vitro" organ toxicity using cellular models. Step-by-step practical tips on how to perform and interpret assays for drug metabolism and toxicity assessment are provided, along with a comparison of different techniques available. It is a welcome addition to the literature at a time when interest is growing in cellular "in vitro" models for toxicology and pharmacology studies.
Key Features
* Meets the continuing demand for information in this field
* Compares "In Vitro" techniques with other methods
* Describes cell-culture methods used to investigate toxicity in cells derived from different organs
* Includes contributions by leading experts in the field

This practical guide offers concise coverage of the scientific and pharmaceutical aspects of protein delivery from controlled release microparticulate systems-emphasizing protein stability during encapsulation and release.

In this unique book, experts describe practices applicable to the large-scale processing of biotechnological products. Beginning with processing and bulk storage preservation techniques, the book provides strategies for improving efficiency of process campaigns of multiple products and manufacturing facilities for such processing techniques. Large-scale chromatography for the purification of biomolecules in manufacturing and lyophilization of protein pharmaceuticals are discussed. Includes a case study on blow-fill-seal processing technology and a chapter on economic and cost factors for bioprocess engineering.

The nutritional and medicinal value of metals, such as zinc, calcium, and iron, has been known in traditional medicine for a long time. Other metals, such as silver and gold, may also have therapeutic and health benefits. Ancient medicines have long incorporated their use in the treatment of diseases, and they have also more recently been explored for treatment in allopathic medicine, birthing the concept of metallonutraceuticals. The challenge of using metals in the human body is to find forms that are safe and effective. Handbook of Metallonutraceuticals presents basic concepts related to the nutritional and therapeutic use of metals, product development strategies, and some ideas ready to be applied for condition-specific metallonutraceuticals. The book begins with an overview of the nutraceuticals field and the need for metallonutraceuticals. It considers the roles of various metals in metabolism, reviews the ethnopharmacology and ethnomedicine of metals, and covers the characterization and possible properties of metallonutraceuticals. It also examines bioavailability and drug interactions, and therapeutic applications of nanometals including use as imaging agents, in cancer diagnosis and treatment, as antibacterials and antivirals, in ocular disease, and in neurodegenerative diseases. The book explores the use of metals in traditional Chinese medicine, potential applications for metalloenzymes, the use of nanosilver in nutraceuticals, and the potential of gold nanoparticles as a drug delivery system. In addition, it addresses intellectual property rights and regulatory considerations regarding metallonutraceuticals. Using an interdisciplinary approach, this user-friendly text provides a knowledge base and inspiration for new research in this exciting field.

Written by the pioneers of Viagra, the first blockbuster PDE inhibitor drug.
Beginning with a review of the first wave of phosphodiesterase (PDE) inhibitors, this book focuses on new and emerging PDE targets and their inhibitors. Drug development options for all major human PDE families are discussed and cover diverse therapeutic fields, such as neurological/psychiatric, cardiovascular/metabolic, pain, and allergy/respiratory diseases. Finally, emerging chemotherapeutic applications of PDE inhibitors against malaria and other tropical diseases are discussed.

A concise guide to mathematical modeling and analysis of pharmacokinetic data, this book contains valuable methods for maximizing the information obtained from given data. It is an ideal resource for scientists, scholars, and advanced students.

This unique reference examines the modern pharmaceutical compacting techniques used to form tablets out of powders-describing the physical structure of pharmaceutical compacts, the bonding phenomena that occur during powder compaction, and the compression mechanisms of pharmaceutical particles.

The seventh volume of Advances in Pharmaceutical Sciences heralds a welcome continuation of this well-respected series. Acknowledged experts provide comprehensive statements of current research and development in selected fields of pharmaceutical technology. This book will be of great value to those working in academia and the pharmaceutical industry.

Asceptic Pharmaceutical Manufacturing II explores the sophisticated technology, developments, and applications that allow aseptic processing to approach the sterility levels achieved with terminal sterilization. Written by experts in sterile manufacturing, this book covers aseptic technology, developments, and applications and makes a valuable contribution to understanding the issues involved in aseptic manufacture. Topics include the processing of biopharmaceuticals, lyophilization, personnel training, radiopharmaceuticals, hydrogen peroxide vapor sterilization, regulatory requirements, validation, and quality systems.

This book focuses on analytical similarity assessment in biosimilar product development following the FDA's recommended stepwise approach for obtaining totality-of-the-evidence for approval of biosimilar products. It covers concepts such as the tiered approach for assessment of similarity of critical quality attributes in the manufacturing process of biosimilar products, models/methods like the statistical model for classification of critical quality attributes, equivalence tests for critical quality attributes in Tier 1 and the corresponding sample size requirements, current issues, and recent developments in analytical similarity assessment.

Pharmaceutical manufacture is very exacting - for example, drugs must be uniform in size, shape, efficacy, bioavailability, and safety. The presence of different polymorphs in drug production is a serious problem, since different polymorphs differ in bioavailability, solubility, dissolution rate, chemical and physical stability, melting point, color, filterability, density, and flow properties. Fine Particles in Medicine and Pharmacy discusses particle size, shape, and composition and how they determine the choice of polymorph of a drug.

This book is the first to provide both a broad overview of the current methodologies being applied to drug design and in-depth analyses of progress in specific fields. It details state-of-the-art approaches to pharmaceutical development currently used by some of the world's foremost laboratories. The book features contributors from a variety of fields, new techniques, previously unpublished data, and extensive reference lists.

This book exploits an understanding of disease pathogenesis by applying a variety of biological agents to therapy. It provides a broad overview of the current methodologies being applied to biological approaches to rational drug design and in depth analyses of progress in this specific field.