The source Dermal Absorption and Toxicity Assessment supplies a state-of-the-art overview of the dermal absorption process, and is divided into six well organized sections. Written by internationally recognized experts in the field, this Second Edition is a complete revised and updated text, covering the wide range of methods used to assess skin absorption and the various governmental and industrial programs concerned with skin permeation and toxicity. These include alternative in silico, in vitro, and in vivo strategies to conduct studies for regulatory requirements. To make room for this...
The source Dermal Absorption and Toxicity Assessment supplies a state-of-the-art overview of the dermal absorption process, and is divided into six we...
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 in drug metabolism and drug interactions
the integral role of pharmacogenetics in metabolism-based drug-drug interactions
in vivo - in vitro correlations (reversible,...
Authored by renowned leaders in the field, this comprehensive volume covers all aspects of drug-drug interactions, including preclinical, clinical,...
This title is intended to assist pharmaceutical scientists in the development of stable protein formulations during the early stages of the product development process, providing a comprehensive review of mechanisms and causes of protein instability in formulation development, coverage of accelerated stability testing methods and relevant analytical methods, and an overview of the drug substance manufacturing process. Preformulation and the development of traditional solutions and lyophilized formulations frequently used for intravenous delivery and non-traditional formulations are also...
This title is intended to assist pharmaceutical scientists in the development of stable protein formulations during the early stages of the product de...
With the advent of analytical techniques and capabilities to measure particle sizes in nanometer ranges, there has been tremendous interest in the use of nanoparticles for more efficient methods of drug delivery. Nanoparticulate Drug Delivery Systems addresses the scientific methodologies, formulation, processing, applications, recent trends, and emerging technologies in the research of nanoparticulate drug delivery systems (NPDDS). It extensively covers applications of NPDDS including lipid nanoparticles for dermal applications; nanocarriers for the treatment of...
With the advent of analytical techniques and capabilities to measure particle sizes in nanometer ranges, there has been tremendous interest in the ...
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. The goal of this book is to help organizations gain rapid regulatory approval.
Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition:
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This Second Edition is an essential guide to preparing for FDA pre-approval inspections taking into account current trend...
This source expertly examines the discovery, control, and application of endotoxin form a parenteral manufacturing perspective, including discussioins of assay development, automation, depyrogenation, and the regulation of endotoxin testing by amebocyte lysate(LAL) methods. Completely revised and expanded, this source contains the knowledge necessary to apply endotoxin technologies in the increasingly complex pharmaceutical environment, and offers neew ans state-of-the-art sections on medical devices, regulation standards, validation procedures, and automated system dvelopments.
This source expertly examines the discovery, control, and application of endotoxin form a parenteral manufacturing perspective, including discussioins...
This title demonstrates how advanced formulation designs and delivery technologies can be used to improve drug efficacy and treatment outcomes in particular therapeutic categories or disease states. It discusses nanoparticle systems for cancer treatments, and also presents cutting edge immono-regulation agents for transplantation and the local targeting of drugs, especially poorly water soluble drugs to provide enhanced therapeutic outcomes. In addition, this title highlights areas of therapy showing the most promise for improvement in clinical outcomes via advanced formulation design.
This title demonstrates how advanced formulation designs and delivery technologies can be used to improve drug efficacy and treatment outcomes in part...
Identifying current tools, techniques, and approaches for the evaluation of laboratory operations, this reference reviews the latest regulatory standards and auditing practices to test laboratory safety, quality, and performance.
Identifying current tools, techniques, and approaches for the evaluation of laboratory operations, this reference reviews the latest regulatory standa...
This reference provides a concise overview of the key principles in dose selection and optimization and demonstrates applicability to recent successful new drug applications. Compiling key issues and current research on safety, efficacy, and clinical pharmacology, and PK-PD, this volume critically highlights the multidisciplinary nature of drug development and spans the fields of pharmacokinetics, clinical pharmacology, biostatistics, and experimental medicine.
This reference provides a concise overview of the key principles in dose selection and optimization and demonstrates applicability to recent successfu...
Nanoparticles, products of nanotechnology, are of increasing interest to the pharmaceutical community. They can increase drug solubility, enhance bioavailability, allow tissue targeting, offer decreased side-effects, and improve therapeutic efficacy. Presenting the most pertinent and practical issues in the manufacturing and biological application of nanoparticles, this source presents state-of-the-art scientific contributions by seasoned authorities in the field.
Nanoparticles, products of nanotechnology, are of increasing interest to the pharmaceutical community. They can increase drug solubility, enhance bioa...
