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Drug Bioavailability
The peroral application (swallowing) of a medicine means that the body must first resorb the active substance before it can begin to take effect. The efficacy of drug uptake depends on the one hand on the chemical characteristics of the active substance, above all on its solubility and membrane permeability. On the other hand, it is determined by the organism's ability to absorb pharmaceuticals by way of specific transport proteins or to excrete them. Since many pharmacologically active substances are poorly suited for oral intake, a decisive criterion for the efficacy of a medicine is its so-called bioavailability. Written by an international team from academia and the pharmaceutical indust...
Oral Lipid-Based Formulations
Oral lipid-based formulations are attracting considerable attention due to their capacity to facilitate gastrointestinal absorption and reduce or eliminate the effect of food on the absorption of poorly water-soluble, lipophilic drugs. Despite the obvious and demonstrated utility of these formulations for addressing a persistent and growing problem
Generic Drug Product Development
The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important comp
Freeze-Drying/Lyophilization Of Pharmaceutical & Biological Products, Revised and Expanded
Thoroughly acquainting the reader with freeze-drying fundamentals, Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition carves practical guidelines from the very latest theoretical research, technologies, and industrial procedures. It delineates the best execution of steps from closure preparation and regulatory control of products to equipment sterilization and process validation. With 13 new chapters providing state-of-the-art information, the book unveils innovations currently advancing the field, including LYOGUARD® packaging for bulk freeze-drying and the irradiation of pharmaceutical and biological products.
Environmental Monitoring for Cleanrooms and Controlled Environments
A critical technology in the science of contamination control, environmental monitoring is a technique that provides important data on the quality of a process, processing environment, and final product, which can aid scientists in identifying and eliminating potential sources of contamination in cleanrooms and controlled environments. In response
Pharmaceutical Photostability and Stabilization Technology
Based on a training course developed by Dr. Joseph T. Piechocki and other experts in this field whose contributions appear in this book for two International Meetings on the Photostability of Drugs and Drug Products, this text clarifies the guidelines set by the International Conference on Harmonization (ICH) and provides a comprehensive background
Transdermal Drug Delivery Systems
Presents authoritative state-of-the-art discussions of the key issues pertinent to transdermal drug delivery, examining those topics necessary to enable a critical evaluation of a drug candidate's potential to be delivered across the skin; from physical chemistry and assessment of drug permeability to available enhancement technolgies, to regulator
Pharmacogenomics
"Summarizes the history of, and available applications, techniques, and approaches to, pharmacogenomics--improving efficacy and tolerance to pharmaceutical compounds, evaluating pharmacogenomics on clinical trial design, and increasing the chances of successful clinical trials and patient outcomes. Compares pharmacogenomics to pharmacogenetics, focusing on the essential components that incorporate individual genetic variations to drug regimens resulting in different responses to therapeutics."
Endotoxins
This source expertly examines the discovery, biological structure, control, and continued clarification of endotoxin from a parenteral manufacturing perspective, with in-depth discussion of state-of-the-art technologies involving Limulus amebocyte lysate (LAL) such as assay development, automation, depyrogenation. Completely revised and exp
Pharmaceutical Gene Delivery Systems
This volume examines the advantages and limitations of the major gene delivery systems and offers guidelines to select the most appropriate viral or synthetic delivery system for specific therapeutic applications. It discusses advances in the design, optimization, and adaptation of gene delivery systems for the treatment of cancerous, cardiovascular, pulmonary, genetic, and infectious diseases.
