Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority's requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions. This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems is correctly achieved.

Numerous phenomenal advances have been made towards understanding the role of neurotransmitters in the pathophysiology of neurological disorders, and these have resulted in a large number of novel molecules with the potential to revolutionize the treatment and prevention of such disorders. This book provides a comprehensive and detailed explanation of brain neurotransmitters and their receptors and associated channels. It includes a basic introduction, and also discusses the functions and recent advances and their pharmacology, highlighting the role of various computer aided drug design (CADD) strategies for the development of therapeutic ligands to modulate these receptors/ion channels. Written in an easy-to-read style, it is intended for neuroscience and pharmaceutical students and researchers working in the area of brain neurotransmitters.

The first authoritative overview of past and current strategies for successful drug development by analog generation, this unique resource spans all important drug classes and all major therapeutic fields, including histamine antagonists, ACE inhibitors, beta blockers, opioids, quinolone antibiotics, steroids and anticancer platinum compounds.

Of the 19 analog classes presented in detail, 9 are described by the scientists who discoverd them.

The book includes a table of the most successful drug analogs as based on the IMS ranking and compares them in terms of chemical structure, mode of action and patentability.

Healing Plants of Nigeria: Ethnomedicine and Therapeutic Applications offers comprehensive information on the use of herbal medicines in West Africa. Combining an evidence-based, ethnobotanical perspective with a pharmacological and pharmaceutical approach to phytomedicine, the book bridges the gap between the study of herbal plants' pharmacological properties and active compounds for the development of clinical drugs and community-oriented approaches, emphasising local use. It demonstrates how the framework of African traditional medicine can be preserved in a contemporary clinical context. The book outlines the history and beliefs surrounding the traditional use of herbs by the local population alongside their application in contemporary phytotherapy in Nigeria and West Africa. It features a critical assessment of the scientific rationale behind the use of these plants in ethnomedicine and offers a composite catalogue of phytotherapeutic and wellness agents, detailing the safety profile, efficacy, and scientific integrity of plants used to treat diseases and optimise health. Features: An ethnobotanical survey containing over 200 full-colour photographs of Nigerian and West African plants. A unique combination of ethnobotany and pharmacognosy, bridging the divide between pharmaceutical and community-oriented approaches to herbal medicine research. Contextual discussion of the therapeutic potential of Nigerian herbal medicine. Offers a template which can be used to separate the superstitious aspects of ethnomedicine from culturally inherited deposits of knowledge. A handbook for herbal and natural medicine practitioners, the book is aimed at African thinkers, scientists, healthcare providers and students of pharmacology and ethnomedicine.

Membrane processes are increasingly used in pharmaceutical and biochemical engineering and biotechnology for concentration and purification, synthesis of molecules and drug delivery systems, and support for biochemical reactions. This book provides a state-of-the art overview of the classical membrane processes used in pharmaceutical and biochemical engineering and biotechnology, such as ultrafiltration, microfiltration, virus filtration, membrane chromatography, membrane emulsification, liquid membranes and membrane bioreactors. It describes the general rules (principles, choice of configurations, membranes, parameters, etc.), recent developments (fouling control, increase permeate flux and selectivity, etc.), applications, and theoretical descriptions. Further, it presents emerging processes such as solvent resistant nanofiltration and membrane crystallization.
Presents classical membrane processes such as ultrafiltration, microfiltration, virus filtration, membrane chromatography, membrane emulsification, liquid membranes and membrane bioreactorsPresents emerging processes such as solvent resistant nanofiltration and membrane crystallizationGives a complete description of each technique (principles, membrane materials and devices, fouling control, and theoretical description)Contains numerous examples of applicationsIncludes a uniformnotation throughout the book enhancing the presentation and understanding of the contentIncludes extensive list of references"

Statistical Design, Monitoring, and Analysis of Clinical Trials, Second Edition concentrates on the biostatistics component of clinical trials. This new edition is updated throughout and includes five new chapters. Developed from the authors' courses taught to public health and medical students, residents, and fellows during the past 20 years, the text shows how biostatistics in clinical trials is an integration of many fundamental scientific principles and statistical methods. The book begins with ethical and safety principles, core trial design concepts, the principles and methods of sample size and power calculation, and analysis of covariance and stratified analysis. It then focuses on sequential designs and methods for two-stage Phase II cancer trials to Phase III group sequential trials, covering monitoring safety, futility, and efficacy. The authors also discuss the development of sample size reestimation and adaptive group sequential procedures, phase 2/3 seamless design and trials with predictive biomarkers, exploit multiple testing procedures, and explain the concept of estimand, intercurrent events, and different missing data processes, and describe how to analyze incomplete data by proper multiple imputations. This text reflects the academic research, commercial development, and public health aspects of clinical trials. It gives students and practitioners a multidisciplinary understanding of the concepts and techniques involved in designing, monitoring, and analyzing various types of trials. The book's balanced set of homework assignments and in-class exercises are appropriate for students and researchers in (bio)statistics, epidemiology, medicine, pharmacy, and public health.

"Pharmacology for Chemists, Second Edition" is aimed at industrial and academic organic chemists holding advanced degrees who are entering the field of medicinal chemistry, and who have had little or no education in or exposure to the biological sciences, especially physiology and pharmacology. The first portion of this book concentrates on biological/pharmacological principles and concepts, and the second portion demonstrates how these concepts and principles are applicable to the medicinal chemists efforts, by describing some selected categories of drugs as examples. The book is not intended to be a textbook of pharmacology, but rather is intended to serve as a tool to prepare the reader for further study and more in depth reading.

Botanicals, which have been part of human food and medicine for thousands of years, are perceived as being safer than synthetic pharmaceuticals. The global botanical drug market was expected to reach $26.6 billion by 2017. In terms of FDA regulations, botanical drugs are no different from non-botanical products, having to meet the safety and effectiveness standards of a new drug in accordance. This book comprises a complete start-to-end process from drug-idea conception, to drug development process. Key Features: Provides a complete compendium for botanical drug products Describes what BDP is and how it differs from Pharma, Biopharma, and Nutraceuticals Compiles all critical regulatory steps in a variety of countries Discusses clinical trial management for BDP development and how it differs from conventional chemical-based drugs and biopharmaceutics

This book presents the state of the art in glycoscience and proposes a road map for the coming decade, focusing on the potential of glycoscience research to shed light on important basic science issues and give rise to exciting new applications, especially in the field of diagnosis and therapeutics. Individual sections offer in-depth coverage of various topics relating to glycans and biopharmaceuticals, glycans in medical science and medicine, glycan technologies, glycans in food and nutrients, and glycan-related materials and their uses. In addition, the book presents an exemplary training course on glycomics and highlights educational and analytical web resources, and also includes glossaries and boxes summarizing key facts to ensure ease of understanding for non-expert readers and students. Written by more than 150 active participants in the Japan Consortium for Glycobiology and Glycotechnology (JCGG), whose goal is to promote the development of interdisciplinary glycoscience and establish a global network in the field, it is a valuable resource for students, postdocs, and researchers in the life sciences as well as for stakeholders and professionals in government, funding agencies and industry.

This brief explores recent progress in the area of polysaccharides and their composites and nanocomposites. It is a complete resource for the evolving field of polysaccharide based biomaterials and their applications in different fields. The volume focuses on their composition, properties, characterization, chemistry and applications and also highlights recent developments in polysaccharide based composites and nanocomposites spurred by advances in polymer technology and biotechnology. Divided into different sections featuring alginates, carrageenans, cellulose, starch, chitin, chitosan, gums, etc, each chapter presents chemical, physical, and biological attributes, and reviews the recent research performed such as drug carriers, selective water absorption materials from oil-water emulsions, purification of water, biomedical applications, etc. The authors hope that this brief will help to inspire scientists towards novel sources for chemicals, materials, and energy in the years to come.

A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. * Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing * Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design * Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions * Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.

Written as an introductory pharmacology text, Basic Pharmacology: Understanding Drug Actions and Reactions provides the in-depth discussion of the chemical and molecular pharmacology fundamentals that pharmacy students require to move on to more advanced study. The book covers the principles of chemistry and biology necessary to understand drug action at the cellular level. It emphasizes the chemical and physical properties of drugs, drug absorption and distribution, drug interactions with cellular receptors, and drug metabolism and interactions. The book effectively explains chemical and molecular pharmacology principles with extensive use of model drug molecules.

Computational biology drives discovery through its use of high-throughput informatics approaches. This book provides a road map of the current drug development process and how computational biology approaches play a critical role across the entire drug discovery pipeline. Through the use of previously unpublished, real-life case studies the impact of a range of computational approaches are discussed at various phases of the pipeline. Additionally, a focus section provides innovative visualisation approaches, from both the drug discovery process as well as from other fields that utilise large datasets, recognising the increasing use of such technology. Serving the needs of early career and more experienced scientists, this up-to-date reference provides an essential introduction to the process and background of drug discovery, highlighting how computational researchers can contribute to that pipeline.

The second edition defines the tools used in QA/QC, especially the application of statistical tools during analytical data treatment. Clearly written and logically organized, it takes a generic approach applicable to any field of analysis. The authors begin with the theory behind quality control systems, then detail validation parameter measurements, the use of statistical tests, counting the margin of error, uncertainty estimation, traceability, reference materials, proficiency tests, and method validation. New chapters cover internal quality control and equivalence method, changes in the regulatory environment are reflected throughout, and many new examples have been added to the second edition.

Antisense-based drugs are part of a growing number of pharmaceutical and biotech programs to treat diseases including cancer, diabetes, and ALS. Reviewing fundamentals and offering guidelines for drug discovery and development, this book is a practical guide from the safety assessment to clinical experience with antisense oligonucleotides. Examines principles and tools for scientists in both pre-clinical and clinical settings and how to apply them to antisense oligonucleotides Reviews fundamentals and provides guidelines for scientists in drug design and discovery to increase efficiency, assessment, and success of drug candidates Helps readers understand antisense molecules and their targets, biochemistry and toxicity mechanisms, roles in disease, and applications for safety and therapeutics Includes interdisciplinary perspectives, from both academia and research, on a hot topic that combines pharmacology, toxicology, biology, and medicinal chemistry to advance our understanding and application of therapeutics

This book examines stealth liposomes from a multidisciplinary approach, which includes theoretical polymer physics, organic synthesis, colloid science, and biology. Discussions include theory, chemistry, biochemistry, pharmacology, preclinical studies in model systems, and medical applications in humans.

Key features include: Details the role of plants for the treatment and management of cancer and diabetes Discusses the role of phytocompounds as ligands for cancer and diabetic targets Reviews plants and the potential of phytochemicals as antidiabetic and anticancer drugs Explores the green biosynthesis of nanoparticles and their treatment efficiency

Delivery of Drugs: Expectations and Realities of Multifunctional Drug Delivery Systems, Volume Two examines the formulation of micro-nanosized drug delivery systems and recaps opportunities for using physical methods to improve efficacy via mechano-, electroporation. The book highlights innovative delivery methods like PIPAC, including discussions on the regulatory aspects of complex injectables. Written by a diverse range of international researchers from industry and academia, the chapters examine specific aspects of characterization and manufacturing for pharmaceutical applications as well as regulatory and policy aspects. This book connects formulation scientists, regulatory experts, engineers, clinical experts and regulatory stakeholders. This level of discussion makes it a valuable reference resource for researchers in both academia and the pharmaceutical industry who want to learn more about the status of drug delivery systems.

This book documents the long, still ongoing battle between the US Food and Drug Administration and the dietary supplement industry. It presents the complex, often subtle, and sometimes overlooked series of events that had a major impact on how dietary supplements are manufactured, marketed, sold, and used today. While the first few chapters focus on some background topics, the remaining chapters walk the reader through timeline of events, legislative actions, FDA proposed and final rules, and judicial decisions that led to our current dietary supplement regulatory framework. Interwoven in narrative are examples of the roles of science, social and public policy, politics, and popular media.

This book explores the use of various plant polysaccharides for pharmaceutical purposes, including drug delivery. It examines the exploitation of plant polysaccharides' auxiliary functions to enhance drug release, stability, bioavailability and target specificity. Plant-derived materials are at the center of drug-delivery research thanks to their non-toxicity, biodegradability, ready availability, eco-friendliness and low extraction costs. These materials include polysaccharides, a class of naturally occurring polymers consisting of glucose monomers, which serve as storage carbohydrates in cereals, root vegetables, rhizomes, seeds, fruits, etc.

This book provides an overview of the world market of therapeutic enzymes and enzyme inhibitors, rare diseases, orphan drugs, the costs of drug development and therapies, and enzymes in downstream processing of pharmaceuticals. It discusses carbonic anhydrase inhibitors and their multiple drug interactions, carboxylesterase inhibitors for pharmaceutical applications, employment of inhibitors for the treatment of neurodegenerative diseases, use of engineered proteins, bioactive peptides, and fibrinolytic enzymes for thrombolytic therapy, and enzymes important for the design and development of new drugs/drug metabolites such as aldehyde oxidases and cytochrome P450 enzymes and the role the latter play in vascular biology and pathophysiology. The treatment of cancer is explored in connection with enzymatic amino acid deprivation therapies and new drugs that act as chemical degraders of oncogenic proteins. The book also introduces the resistance mechanisms of cancer. Furthermore, it provides an insight into the relationship between pathological conditions of cardiovascular disease and oxidative stress. The text also focuses on the potential use of nanoparticles as carriers for enzymes with medical relevance, computer-aided drug design for the identification of multi-target directed ligands, and the development of improved therapeutics through a glycan-"designer" approach. It concludes with an introduction to the chemoenzymatic synthesis of drugs.

Thiscomprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book:

Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines

Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures

Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers

This book is a useful resource to scientists and researchers in bothindustry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development."

Immunology has emerged as a key component of the curricula of graduate and postgraduate courses in biotechnology, microbiology, biochemistry, bioinformatics, and other interdisciplinary fields of biology, including zoology, veterinary science, and medicine. As a basic introductory textbook on one of the fastest-moving and most challenging areas of immunological science, this book contains the most recent information about immunologic mechanisms and their importance, along with various molecular techniques employed in immunology. The short and concise text helps make the structures, processes, and interactions of the immune system easily comprehensible. The book includes chapters on immunoinformatics as well as the immune system of the brain, rarely found in any of the immunology books published so far. Many diverse and interesting aspects of the advances in immunology have also been covered, including tumor immunology and immunodeficiency disorders. The easy-to-understand concepts presented in the textbook make it an ideal companion for learners preparing for competitive and other examinations. Undergraduate, postgraduate, and PhD students, people from the industry and academia, and research scholars will immensely benefit from it.