The biopharmaceutical industry as we know it today is going through a massive upheaval as a result of the uncertainty of healthcare reform and increasing regulatory pricing pressure.
Recent Advancement in ProdrugsDrugs used as medicines have many limitations like low chemical stability, aqueous solubility, or oral absorption/bioavailability, rapid presystemic metabolism, toxicity, inadequate site specificity, or poor patient acceptance/compliance (unwanted adverse effects, unacceptable taste or odor, irritation or pain).
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.
A major target of Goal 3 of the Sustainable Development Goals adopted by the United Nations in 2015 is the elimination of 'the epidemics of AIDS, tuberculosis, malaria and neglected tropical diseases' and combating 'hepatitis, water-borne diseases and other communicable diseases'.
A practical guide to all key the elements of pharmaceuticals and biotech manufacturing and design Engineers working in the pharmaceutical and biotech industries are routinely called upon to handle operational issues outside of their fields of expertise.
The second edition of this text assembles significant ophthalmic advances and encompasses breakthroughs in gene therapy, ocular microdialysis, vitreous drug disposition modelling, and receptor/transporter targeted drug delivery.
Providing guidance for chemists and other scientists entering pharmaceutical discovery and development, this up-to-the-minute reference presents contributions from an international group of nearly 50 renowned researchers-offering a solid grounding in synthetic and physical organic chemistry, and clarifying the roles of various special
Strategize, plan, and execute comprehensive drug-drug interaction assessments for therapeutic biologics Offering both theory and practical guidance, this book fully explores drug-drug interaction assessments for therapeutic biologics during the drug development process.
Frank discussions of opportunities and challenges point the way to new, more effective drug delivery systems Interest in nanomedicine has grown tremendously, fueled by the expectation that continued research will lead to the safe, efficient, and cost-effective delivery of drugs or imaging agents to human tissues and organs.
As a result of new statistical and mathematical approaches, improved visualization tools, and recognition by international regulatory groups, quantitative structure-activity relationships (QSARs) now play important roles in pharmacology for the design of new drugs as well as in toxicology and ecotoxicology for hazard identification and risk assessm
Integrating the clinical and engineering aspects of drug delivery, this book offers a much needed comprehensive overview and patient-oriented approach for enhanced drug delivery optimization and advancement.
The identification of drug targets in a given disease has been central to pharmaceutical research from the latter half of the 20th century right up to the modern genomics era.
Review of the First Edition"e;The goal of this book, as stated by the authors, is to fill the knowledge gap that exists between developed statistical methods and the applications of these methods.
The rapid growth of Complementary and Alternative Medicine (CAM) demands that the public, the medical world, social scientists, the media, and governments pay attention.
Transgenic plants present enormous potential to become one of the most cost-effective and safe systems for large-scale production of proteins for industrial, pharmaceutical, veterinary, and agricultural uses.
The enormous advances in nanomedicine and precision medicine in the past two decades necessitated this comprehensive reference, which can be relied upon by researchers, clinicians, pharmaceutical scientists, regulators, policymakers, and lawyers alike.
Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials gives a thorough presentation of state-of-the-art methods for early phase clinical trials.
Completely revised and updated, this third edition of Pharmaceutical Dosage Forms and Drug Delivery elucidates the basic principles of pharmaceutics, biopharmaceutics, dosage form design, and drug delivery - including emerging new biotechnology-based treatment modalities.
Several developed countries are facing serious problems in medical environments owing to the aging society, and extension of healthy lifetime has become a big challenge.
This book details several important medicinal plants, their occurrence, plant compounds and their chemical structures, and pharmacological properties against various human diseases.
As a guide for pharmaceutical professionals to the issues and practices of drug discovery toxicology, this book integrates and reviews the strategy and application of tools and methods at each step of the drug discovery process.
Natural Health Sciences: A Comprehensive Guide serves as a valuable resource for both healthcare practitioners and business professionals, supporting ongoing professional development by bridging the gap between proponents of traditional or natural health systems and those who follow scientific or medical perspectives.
This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance.
With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing.
Drug repurposing is the development of existing drugs for new uses: given that 9 in 10 drugs that enter drug development are never marketed and therefore represent wasted effort, it is an attractive as well as inherently more efficient process.
All too often, the words "e;computer validation"e; strike terror into the hearts of those new to the process and may even cause those familiar with it to tremble.
Antibodies protect us from a wide range of infectious diseases and cancers and have become an indispensable tool in science-both for conventional immune response research as well as other areas related to protein identification analysis.
Written by experts that include originators of some key ideas, chapters in the Handbook of Multiple Testing cover multiple comparison problems big and small, with guidance toward error rate control and insights on how principles developed earlier can be applied to current and emerging problems.
Nonclinical Safety Assessment Nonclinical Safety Assessment A Guide to International Pharmaceutical Regulations Bringing a new drug to market is a costly time-consuming process.
Biologically Active Small Molecules: Modern Applications and Therapeutic Perspectives focuses on small molecules as active pharmacological agents, their pharmacotherapeutically active properties, new approaches in drug discovery using small molecules, and biopharmaceutic approaches for low molecular weight ligands.
An authoritative review of the latest developments in the chemical biology of enzymes In the first decade of the twenty-first century, enzymes and their multiple applications have played a critical role in the discovery and development of many new therapeutic agents.
Advances in biotechnology have provided scientists with an increasing number of biopharmaceuticals such as novel peptide and protein drugs as well as nucleic acid based drugs for gene therapy.
Nonpharmacological treatments include a wide variety of treatments such as surgery, technical procedures, implantable and non-implantable devices, rehabilitation, psychotherapy, and behavioral interventions.
Sociology for Pharmacists: An Introduction is written specifically for professionals and students in pharmacy who are newcomers to the study of sociology.
Using time-to-event analysis methodology requires careful definition of the event, censored observation, provision of adequate follow-up, number of events, and independence or "e;noninformativeness"e; of the censoring mechanisms relative to the event.
