Provides a systematic coverage on the application of materials science techniques to the pharmaceutical field, offering a comprehensive program for the physical characterization of raw materials, drug substances, and formulated products.
Explains pharmaceutical transport phenomena. This book focuses on practical applications of drug delivery from a physical and mechanistic perspective, highlighting biological systems. It demonstrates applications like drug or nutrient uptake into vesicle or cell suspensions, drug dissolution and absorption across biological membranes and others.
Containing surveys of procedures and systems for the microbiological and quality control analysis of pharmaceutical products, this text also highlights emerging technologies and systems used to prevent contamination in microbial processes.
Highlighting key points from the latest regulatory requirements, this book helps those new to the world of pharmaceutical development understand regulatory steps, reduce cost and attain guidance through each step of the drug approval process.
This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications.
Herbal Supplements-Drug Interactions
This book is based on research papers and commentaries on pharmacokinetic methods and applications published since 1975. It offers detailed examinations of new developments in the pharmacokinetic field with enhanced clarity of presentation and simplified organization.
Demonstrates how substitution of a variety of ligands can render albumin a targeting tool for selective drug accumulation in various cell populations of the liver! This book discusses physical, chemical, and biological approaches to drug targeting technology. It is for pharmacists, pharmacologists, and pharmaceutical scientists; and others.
Detailing the need for, and stressing the importance of, an audit of clinical data to protect participants and validate study results. This book examines the use of computers, the Internet, and third-party organizations to assist in data validation. It positions the audit as a tool to verify that a drug is safe and effective in clinical trials.
A work which furnishes different perspectives on pharmaceutical information automation from industry and system automation professionals - demonstrating how to fulfil computer system validation requirements for hardware, applications, networks, data center operations, and complex software management practices in pharmaceutical manufacturing.
Presenting applications in clinical development, pharmacokinetic/ pharmacodynamic modelling and clinical trial simulation, this reference studies the role of biomarkers in successful drug formulation and development.
Laboratory Auditing for Quality and Regulatory Compliance
Interconnecting the fundamentals of supercritical fluid (SCF) technologies, their utility in drug delivery, and process engineering advances from related methodological domains and pharmaceutical applications. This book unlocks the potential of supercritical fluids to the development of improved pharmaceutical products.
Examining the modern pharmaceutical compacting techniques used to form tablets out of powders, this book describes the physical structure of pharmaceutical compacts, the bonding phenomena that occur during powder compaction, and the compression mechanisms of pharmaceutical particles.
Revised edition of: Pharmaceutical extrusion technology / edited by Isaac Ghebre-Sellassie, Charles Martin. New York: M. Dekker, 2003.
This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.
An international group of leading experts in drug development and biopharmaceutical science discusses the latest advances in biodrug delivery systems and associated techniques.
When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.
Examines the discovery, biological structure, control, and continued clarification of endotoxin from a parenteral manufacturing perspective. This work shows how to apply endotoxin testing in pharmaceutical environment. It also features information on clinical advances, regulation standards, and validation procedures for computerized kinetic tests.
Offers coverage of the scientific and pharmaceutical aspects of protein delivery from controlled release microparticulate systems - emphasizing protein stability during encapsulation and release.
Describes assays used to discover new glycopeptide antibiotics. This work discusses practical techniques for screening, isolating and analyzing glycopeptide antibiotics, correlating structure-activity relationships with the mode of action. It examines relevant chemical aspects of the carbohydrate components of glycopeptide antibodies.
This timely resource compares single-photon emission tomography (SPECT), used mainly withTechnetium and iodine for routine clinical examinations, and positron emission tomography(PET) , employing short-lived radionuclides of carbon, oxygen, nitrogen, and fluorine in researchinvestigations
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