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.
Due to the lack of secure, efficient, and patient-friendly therapies for neurodegenerative disorders, there is a rising demand for innovative approaches.
Often considered a necessary evil by the pharmaceutical industry, validation is still understood by many as unrestrained bureaucracy, paperwork, and procedures whose roots and logic are obscure and only serve to slow down progress.
Several Phyllanthus species are widely used in traditional medicine and herbal formulation for the treatment of a variety of ailments such as flu, dropsy, diabetes, jaundice and bladder calculus.
Biotechnology is a multidisciplinary field encompassing microbiology, bichemistry, genetics, molecular biology, chemistry, immunology, cell and tissue culture physiology.
The second volume in the CURRENT TOPICS IN NONCLINICAL DRUG DEVELOPMENT SERIES explores the critical issues and current topics in nonclinical drug development.
As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator's biologic products.
The identification of the role of tumor stroma-the tissue in the surroundings of cancer cells-in cancer development, progression, and metastasis has revolutionized the fields of cancer biology as well as cancer therapeutics.
The book, Clinical Studies in Nutraceuticals and Dietary Supplements, presents extensive information on all the vital aspects and evidence-based studies on nutraceuticals and dietary supplements.
This is the most comprehensive treatise of this topic available, providing invaluable information on the technological and economic benefits to be gained from implementing continuous processes in the biopharmaceutical industry.
This new volume, Nanomedicine for the Treatment of Disease: From Concept to Application, looks at the application of nanomedicines with a particular focus on their use in the treatment of diseases.
Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines.
In response to the pharmaceutical industry's growing need for new chemicals for drug development, researchers are looking at marine sources for novel bioactive natural products.
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.
Plant volatiles-compounds emitted from plant organs to interact with the surrounding environment-play essential roles in attracting pollinators and defending against herbivores and pathogenes, plant-plant signaling, and abiotic stress responses.
Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use.
This Second Edition is an essential guide to preparing for FDA pre-approval inspections-taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st Century, quality systems-based approach to inspections, risk-based inspections, quality by design, process analytical technology, design space, etc.
Aquatic Ecosystems and Microbial Biofilms: Significance, Dynamics, Prevention and Control provides a systematic introduction and review of state-of-the-art information on microbial biofilms in aquatic ecosystems and their control.
Detailing formulation approaches by stage of discovery to early development, this book gives a playbook of practical and efficient strategies to formulate drug candidates with the least chance of failing in clinical development.
In the pursuit of more muscle, enhanced strength, sustained endurance and idealised physiques, an increasing number of elite athletes, recreational sport enthusiasts and body-conscious gym-users are turning to performance and image enhancing drugs and substances (PIEDS).
This book provides a comprehensive overview of biomotors (molecular motors) within the body with a specific concentration on revolving molecular motors.
The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Six, Sterile Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing.
This book details several important medicinal plants, their occurrence, plant compounds and their chemical structures, and pharmacological properties against various human diseases.
This book is an excursion into the drug development process, from the initial conception in a chemical or molecular biology lab, via tests in isolated cells and animals, to the stage of clinical trials.
There is an increasing interest in plants of the Moringa genus used as a source of phytochemicals with biopharmaceutical potential, as a functional ingredient in many products and as an additive in poultry feeding stocks.
This book provides stepwise guidance on how to evaluate, audit, qualify and approve an active pharmaceutical ingredient (API) and packaging material manufacturer and supplier to enhance the GMP within the industry.
This second volume of Metal-Organic Framework Composites focusses on water pollution as a major concern and endangerment to human health and the application of MOFs for remediation.
With chapters from highly skilled, experienced, and renowned scientists and researchers from around the globe, Dendrimers for Drug Delivery provides an abundance of information on dendrimers and their applications in the field of drug delivery.
Enables readers to apply process dynamics and control theory to solve bioprocess and drug delivery problems The control of biological and drug delivery systems is critical to the health of millions of people worldwide.
The management of clinical data, from its collection during a trial to its extraction for analysis, has become critical in preparing a regulatory submission and obtaining approval to market a treatment.
In this era of finite budgets, healthcare rationing, medication shortages, and the global aging and burgeoning of populations, numerous stakeholders in the healthcare arena must understand the basic principles of pharmacoeconomics and how these may be correctly applied to facilitate drug development, rationing, patient segmentation, disease management, and pricing model development.
Complete, referenced information in an easy-to-use formatMany of the monographs in the European Pharmacopiea, the industry standard test for certain groups of ingredients and excipients, do not describe the tests in full, but reference general methods based on test-tube chemistry.
Predictive data science is already in use in many fields, but its application in toxicology is new and sought after by non-animal alternative testing initiatives.