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Biobetters
“Biobetters: Protein Engineering to Approach the Curative” discusses the optimization of protein therapeutic products for treatment of human diseases. It is based on the fact that though numerous important therapeutic protein products have been developed for life threatening and chronic diseases that possess acceptable safety and efficacy profiles, these products have generally not been reexamined and modified for an improved clinical performance, with enhancements both to safety and efficacy profiles. Advances in protein engineering, coupled with greatly enhanced understanding of critical product quality attributes for efficacy and safety, make it possible to optimize predecessor produc...
Transport Processes in Pharmaceutical Systems
This cutting-edge reference clearly explains pharmaceutical transport phenomena, demonstrating applications ranging from drug or nutrient uptake into vesicle or cell suspensions, drug dissolution and absorption across biological membranes, whole body kinetics, and drug release from polymer reservoirs and matrices to heat and mass transport in freeze-drying and hygroscopicity. Focuses on practical applications of drug delivery from a physical and mechanistic perspective, highlighting biological systems. Written by more than 30 international authorities in the field, Transport Processes in Pharmaceutical Systems discusses the crucial relationship between the transport process and thermodynamic...
Modern Pharmaceutics Volume 1
With over 100 illustrations, Volume 1 addresses the core disciplines of pharmaceutics (absorption, PK, excipients, tablet dosage forms, and packaging), and explores the challenges and paradigms of pharmaceutics.Key topics in Volume 1 include: principles of drug absorption, chemical kinetics, and drug stability pharmacokinetics the effect of rout
Pharmaceutical Inhalation Aerosol Technology, Second Edition
This thoroughly revised and expanded reference provides authoritative discussions on the physiologic, pharmacologic, metabolic, molecular, cellular and physicochemical factors, influencing the efficacy and utilization of pharmaceutical aerosol. It analyzes the latest science and developments in the generation, administration and characterization of these compounds, showcasing current clinical applications, the efficiency and limitations of major aerosol products and emerging aerosol therapies impacting the field.
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.
Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms, Third Edition
Thoroughly updated and expanded, this new Third Edition provides the latest information on dosage, forms, film defects, and polymer characterization. Written by renowned leaders in the field, Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms is easily the most comprehensive book available on the market today. New to the Third Edition: the interaction of drugs with functional polymers the influence of processing parameters on coating quality the stabilization of polymeric film coats plasticizers and their applications in pharmaceutical coatings adhesion of polymeric films to solid substrates basic properties of latex and pseudolatex colloidal dispersions Key topics included: polymer interactions with drugs and excipients physical aging of polymeric films a complete overview and in-depth analysis of recent advances in the field, which includes information on the latest equipment used to apply polymers to a pharmaceutical system illustrated examples explaining the appropriate steps to be taken in order to solve formulation, processing, and stability problems to achieve an optimized dosage form
Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics
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.
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
The Pharmaceutical Regulatory Process
This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, an
