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Supercritical Fluid Technology for Drug Product Development
Interconnecting the fundamentals of supercritical fluid (SCF) technologies, their current and anticipated utility in drug delivery, and process engineering advances from related methodological domains and pharmaceutical applications, this volume unlocks the potential of supercritical fluids to further the development of improved pharmaceutical products-from drug powders for respiratory delivery to drug delivery systems for controlled release.
Preparing for FDA Pre-Approval Inspections
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. Th
Drug-Drug Interactions
Authored by renowned leaders in the field, this comprehensive volume covers all aspects of drug-drug interactions, including preclinical, clinical, toxicological, and regulatory perspectives.Thoroughly updated, this second edition reflects the significant advances and includes extensive new material on:key interplay between transporters and enzymes
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
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
Modern Pharmaceutics, Two Volume Set
This new edition brings you up-to-date on the role of pharmaceutics and its future paradigms in the design of medicines. Contributions from over 30 international thought leaders cover the core disciplines of pharmaceutics and the impact of biotechnology, gene therapy, and cell therapy on current findings. Modern Pharmaceutics helps you stay current
Pharmaceutical Project Management
Encompassing the full spectrum of project management's role and responsibility encountered in the pharmaceutical industry, Pharmaceutical Project Management outlines the key objectives, risks, and challenges of each stage of the pharmaceutical lifecycle, from discovery and preclinical phases through clinical development, manufacturing, registration
In-Vitro and In-Vivo Tools in Drug Delivery Research for Optimum Clinical Outcomes
This book covers the essentials of drug delivery research and provides a unique forum for scientific experimental methods that are exclusively focused by the in-vitro, ex-vivo, and in-vivo methodologies of drug delivery research and felicitates translational research. The book includes recent and novel approaches in evaluation methods of transdermal, nasal, ocular, oral and intraoral, gastro-retentive, colon-targeted, and brain-targeted drug delivery systems. Providing up to date and comprehensive information, this text is invaluable to students, teachers, scientists, and others employed in the field of drug delivery.
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
Good Laboratory Practice Regulations
Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. This all-encompassing Fourth Edition addresse
