Delineates steps for the formulation of liquid parenteral biopharmaceutical products. This book covers pathways for each phase as well as its purpose, function, and relation to other stages in the product development process. It is written by experts involved in advances in the pharmaceutical drug industry.
Environmental Monitoring for Cleanrooms and Controlled Environments
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.
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.
Revised edition of: Pharmaceutical extrusion technology / edited by Isaac Ghebre-Sellassie, Charles Martin. New York: M. Dekker, 2003.
This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends.
This book presents an integrated approach to statistical experimental design to pharmaceutical development, covering all important methods applied to solve the more usual pharmaceutical formulation problem while avoiding mathematical difficulties.
Updating and expanding the scope of topics covered in the previous edition, Percutaneous Absorption supplies new studies on the role of the skin as a key portal of entry for chemicals into the body this book serves as a detailed reference source for recent advances in the field, as well as an experimental guide for laboratory personnel.
Pharmaceutical Extrusion Technology, Second Edition brings together all extrusion related technical information necessary for the development, manufacturing, and marketing of pharmaceutical dosage forms.
Aqueous-based film coating has become routine in the pharmaceutical industry. This process eliminates the use of organic solvents and thus avoids economic, environmental, and toxicological issues related to residual solvents and solvent recovery. Aqueous-based coating, however, is complex and many variables may impact the final product and its p
This volume covers the development of gene therapy, the technology involved, clinical applications of siRNA, non-viral vector-based mRNA delivery using nanotechnology, and RNA based vaccines for treating the infectious diseases.
Gene therapy involves altering the genes in the body¿s cells in an effort to treat or stop disease, instead of using drugs or surgery. This book discusses the development of gene therapy today, from the technology involved to gene correction and the advances in genome editing.
Continuous manufacturing of pharmaceuticals, including aspects of modern process development is highlighted in this book with both the 'why' and the 'how', emphasizing process modeling and process analytical technologies. Presenting specific case studies and drawing upon extensive experience from industry and academic opinion leaders, this book focuses on the practical aspects of continuous manufacturing. It gives the readers the strategic perspective and technical depth needed to adopt and implement these technologies, where appropriate, in order to gain the competitive edge in speed, agility, and reliability.Features:Discusses scientific solutions and process analytical technology to enable continuous manufacturing in the development of new drugsIncludes short stories about how some companies have adopted CM and what their drivers were and what benefits were realizedAddresses economic and practical considerations, unlike many other technical booksEmphasizes the practical aspects to give the reader the strategic imperative and technological depth to adopt and implement these technologiesHighlights the "why" and the "how", focusing on the need analysis and process modeling and process analytical technologies
This all-encompassing volume addresses every critical aspect of Good Laboratory Practice (GLP) regulations and demonstrates effective strategies for implementation in a variety of laboratory settings
Project managers in drug development are the driving force behind the coordination of efforts. This book provides a practical reference for project managers in the pharmaceutical and biotech drug development industry, with the goal of assisting in creating an efficient and effective team structure and environment. The text details the role of project managers at each stage of drug development, the key interfaces that the PM will need to work closely with, and essential tools of the trade including frequently used techniques and methodologies. This book is useful for both entry-level and advanced-level PMs, as well as non-project managers from other functions.FeaturesIncludes authors' recent experience with improved tactics and technologies/software at various stages of drug development.Provides the most up-to-date and best practices, techniques, and methodologies in project management.Details the role of the PM at each stage of drug development, including working with the key interfaces throughout the process.Diverse audience including nonproject managers in clinical development, clinical operations, regulatory affairs, medical affairs, clinical pharmacology, and biostatistics.Provides templates and timelines for critical paths from development to commercialization and has potential as a textbook on relevant courses.
This fully revised and updated third edition of Pharmaceutical Inhalation Aerosol Technology encompasses the scientific and technical foundation for the rationale, design, componentry, assembly and quality performance metrics of therapeutic inhalers in their delivery of pharmaceutical aerosols to treat symptoms or the underlying causes of disease.
This book addresses the various aspects of the RNA-seq technique, especially its application in drug discovery and development, including the identification of new drug targets, the prediction of drug activity or interactions, personalized medicine and toxicogenomics.
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