The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century.
To successfully bring an Active Pharmaceutical Ingredient (API) to market, many steps must be followed to ensure compliance with governmental regulations.
The rapid advancement of semantic web technologies, along with the fact that they are at various levels of maturity, has left many practitioners confused about the current state of these technologies.
GPS-embedded clothing for finding children or skiers when they are lost, bio-monitoring smart shirts, and vests that monitor a patient's vital signs are no longer science fiction but science fact.
This updated Second Edition details how marketers, forecasters, and brand planners can achieve optimal success by building internally consistent simulation models to project future behavior of patients, physicians, and R&D processes.
This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development.
This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development.
In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns.
With step-by-step methods of drug production and knowledge of major unit operations and key concepts of pharmaceutical engineering, this guide will help to improve communication among the varied professionals working in the pharmaceutical industry.
Exploring fundamental concepts, Drug Delivery Nanoparticles Formulation and Characterization presents key aspects of nanoparticulate system development for various therapeutic applications and provides advanced methods used to file for regulatory approval.
Compaction of powder constituents-both active ingredient and excipients-is examined to ensure consistent and reproducible disintegration and dispersion profiles.
Using clear and practical examples, Polymorphism of Pharmaceutical Solids, Second Edition presents a comprehensive examination of polymorphic behavior in pharmaceutical development that is ideal for pharmaceutical development scientists and graduate students in pharmaceutical science.
Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, as well as the shift from developing small molecules to the growth of biopharmaceuticals.
The ultimate goal of drug product development is to design a system that maximizes the therapeutic potential of the drug substance and facilitates its access to patients.
Volume 1 of this two-part package provides a complete set of checklists for internal and contract device and drug manufacturers and developers, contract software developers, and suppliers of chemical, printed material, electronic component, and general supplies.
This title demonstrates how designed experiments are the most scientific, efficient, and cost effective method of data collection for validation in a laboratory setting.
This two volume Second Edition describes the anatomical, physiological, pharmaceutical, and technological aspects of delivery routes, found in areas like:OralOcularDermal and transdermalVaginalColonicOral mucosalNasalPulmonaryProviding insight and critical assessment of the many available and emerging modified release drug delivery systems for thei
The detection of pharmaceutical residues remained elusive until instruments such as liquid chromatography and mass spectrometry became commonplace in environmental laboratories.
Initially written to pull together scattered literature in polymer science and textile technology, the first edition of Coated Textiles: Principles and Applications became a gold standard resource in this field.
This two volume Second Edition describes the anatomical, physiological, pharmaceutical, and technological aspects of delivery routes, found in areas like:Oral Ocular Dermal and transdermal VaginalColonic Oral mucosal Nasal PulmonaryProviding insight and critical assessment of the many available and emerging modified release drug delivery systems fo
This book focuses on sterilizing grade filters in the biopharmaceutical industry, emphasizing practical applications of universal and dependable operational protocols, integrity testing, and troubleshooting to streamline the production and preparation of pharmaceuticals.
Written by an expert for those who must design validatable cleaning processes and then validate those processes, this book discusses interdependent topics from various technical areas and disciplines.
Knowing how to deal with the regulatory issues, understanding the impacts of cleanliness, and recognizing the affect that poor facility layout will have on GMP spaces are only some of the issues an experienced Project Manager must focus on.
Contamination control in pharmaceutical clean rooms has developed from a jumble of science and engineering, knowledge of what has worked well or badly in the past, dependent upon the technology available at the time the clean room was built and subsequent technological developments.
Containing authoritative and in-depth coverage, Producing Biomolecular Materials Using Fermenters, Bioreactors, and Biomolecular Synthesizers examines the bioproduction systems that support the controlled, automated, and quantity growth of proteins.
With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change.
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.
Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms.
The ultimate goal of drug product development is to design a system that maximizes the therapeutic potential of the drug substance and facilitates its access to patients.
Pharmaceutical Dosage Forms: Tablets, Third Editionis acomprehensive treatment of the design, formulation, manufacture, and evaluation of the tablet dosage form.
Pharmaceutical Dosage Forms: Tablets, Volume 1examines the fundamental physical and chemical processes that the different unit oprations use, and then applies this knowledge to the discussion of the varying unit operations and processes.
Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products.
The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart.
An invaluable source instruction on the principles, instrumentation, design, implementation, operation, and maintenance of an effective clean-in-place system (CIP), this guide illustrates best practices and successful applications of CIP in both pharmaceutical and biotechnology facilities.
Pharmaceutical Packaging Handbook provides a complete overview of the role that packaging plays in the development and delivery of pharmaceuticals and medical devices.
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.
Organic Mechanochemistry and Its Practical Applications gathers physical and organic chemistry-based molecular principles, evolving interpretations of scientific data, and real world applications to demonstrate the synthetic advantages of mechanically initiated organic reactions.
Offering step-by-step technical details, Liposome Technology, Third Edition, Three Volume Set provides comprehensive coverage of all aspects of liposome technology, including liposome preparation and analysis, entrapment of drugs and other materials into liposomes, and liposome interaction with the biological environment to be applied in the detect
Unique and informative, Water Properties of Food, Pharmaceutical, and Biological Materials is based on lectures and papers given by leading international researchers at the 9th International Symposium of the Properties of Water in Foods (ISOPOW 9) that took place in September 2004.
