Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations.
This book encompasses the fundamental concepts of Nanochemistry that involve the self-assemblage of nanostructures, surface stabilization, and functionalization of nanoparticles.
Medicinal Natural Products: A Biosynthetic Approach, Third Edition, provides a comprehensive and balanced introduction to natural products from a biosynthetic perspective, focussing on the metabolic sequences leading to various classes of natural products.
Recent regulations on heavy metal testing have required the pharmaceutical industry to monitor a suite of elemental impurities in pharmaceutical raw materials, drug products and dietary supplements.
The field of solid state characterization is central to the pharmaceutical industry, as drug products are, in an overwhelming number of cases, produced as solid materials.
Develop Effective Immunogenicity Risk Mitigation StrategiesImmunogenicity assessment is a prerequisite for the successful development of biopharmaceuticals, including safety and efficacy evaluation.
This book provides information about different types and stages of cancer and their subtypes with their respective molecular mechanisms, etiology, histopathology, and cellular origins.
Nonclinical Safety Assessment Nonclinical Safety Assessment A Guide to International Pharmaceutical Regulations Bringing a new drug to market is a costly time-consuming process.
Complete, Authoritative, Unrivaled CollectionClin-Alert, long established as the pre-eminent source of adverse drug reaction/interaction, now brings you Clin-Alert 2000.
Chemogenomics brings together the most powerful concepts in modern chemistry and biology, linking combinatorial chemistry with genomics and proteomics.
**THE SUNDAY TIMES BESTSELLER | BBC RADIO 4 BOOK OF THE WEEK**The definitive story of COVID-19 and how global politics shape our health - from a world-leading expert and the pandemic's go-to science communicator Professor Devi Sridhar has risen to prominence for her vital roles in communicating science to the public and speaking truth to power.
Brings together functional and structural informationrelevant to the design of drugs targeting zinc enzymes The second most abundant transition element in living organisms, zinc spans all areas of metabolism, with zinc-containing proteins offering both established and potential drug targets.
An integrated view of chiral drugs from concept and synthesisto pharmaceutical properties Chirality greatly influences a drug's biological and pharmacological properties.
Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis provides statisticians with an understanding of the critical challenges currently encountered in oncology trials.
With its focus on concrete methods and recent advances in applying nanotechnology to develop new drug therapies and medical diagnostics, this book provides an overall picture of the field, from the fundamentals of nanopharmacy with the characterisation and manufacturing methods to the role of nanoparticles and substances.
Matrix metalloproteinases (MMPs) have been established as promising biomolecular targets for novel drug design and discovery against numerous major disease conditions including various cancers, cardiovascular, neurodegenerative, inflammatory diseases, and more.
Facilitates the discovery and development of new, effective therapeutics With coverage of the latest mass spectrometry technology, this book explains how mass spectrometry can be used to enhance almost all phases of drug discovery and drug development, including new and emerging applications.
Now the adverse drug reaction events reported in the newsletter Clin-Alert during Y2000 have been compiled, organized, re-formatted, indexed, and published in a convenient one-volume reference book, Clin-Alert 2001.
From the laboratory to full-scale commercial production, this reference provides a clear and in-depth analysis of bioreactor design and operation and encompasses critical aspects of the biocatalytic manufacturing process.
Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making.
Asceptic Pharmaceutical Manufacturing II explores the sophisticated technology, developments, and applications that allow aseptic processing to approach the sterility levels achieved with terminal sterilization.
This book discusses fabrication of functionalized gold nanoparticles (GNPs) and multifunctional nanocomposites, their optical properties, and applications in biological studies.
Backed by leading authorities, this is a professional guide to successful compound screening in pharmaceutical research and chemical biology, including the chemoinformatic tools needed for correct data evaluation.
Understanding and addressing the current opioid crisis requires knowledge of endogenous opioids (endorphins and enkephalins), but there is now evidence for a benzodiazepine crisis.
Covering every essential element in the development of chiral products, this reference provides a solid overview of the formulation, biopharmaceutical characteristics, and regulatory issues impacting the production of these pharmaceuticals.
The Silk Road, a complex network of trade routes linking China with the rest of the Eurasian continent by land and sea, fostered transformation of the ethnic, cultural, and religious identities of diverse peoples.
Cost-effective manufacturing of biopharmaceutical products is rapidly gaining in importance, while healthcare systems across the globe are looking to contain costs and improve efficiency.
Many polymers derived from various marine sources and microorganisms possess some important biological properties such as biocompatibility, biodegradability, and bioadhesivity that make them attractive as pharmaceutical excipients in various pharmaceutical dosage forms.
Important safety aspects of compatibility for therapeutic products and their manufacturing systems, delivery devices, and containers Compatibility of Pharmaceutical Products and Contact Materials helps pharmaceutical, toxicology, analytical, and regulatory affairs professionals assess the safety of leachable and extractable chemicals associated with drug product packaging, manufacturing systems, and devices.
Written for practitioners in both the drug and biotechnology industries, this handbook carefully compiles the current regulatory requirements to correctly and properly validate a new or modified analytical method.
