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.
Because enzyme-catalyzed reactions exhibit higher enantioselectivity, regioselectivity, substrate specificity, and stability, they require mild conditions to react while prompting higher reaction efficiency and product yields.
The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates.
The biopharmaceutical industry has become an increasingly important player in the global economy, and the success of these products depends on the development and implementation of cost-effective, robust and scaleable production processes.
Using time-to-event analysis methodology requires careful definition of the event, censored observation, provision of adequate follow-up, number of events, and independence or "e;noninformativeness"e; of the censoring mechanisms relative to the event.
With over twenty different official regulatory statements worldwide on Good Manufacturing Practice (GMP) for pharmaceutical, drug, or medicinal products, two stand out as being the most influential and most frequently referenced.
An expertly written source on the devices, systems, and technologies used in the dissolution testing of oral pharmaceutical dosage forms, this reference provides reader-friendly chapters on currently utilized equipment, equipment qualification, consideration of the gastrointestinal physiology in test design, the analysis and interpretation of data
All manufacturing companies face the daunting task of designing an employee training matrix that meets the gamut of national and international regulatory standards.
Furthering efforts to simulate the potency and specificity exhibited by peptides and proteins in healthy cells, this remarkable reference supplies pharmaceutical scientists with a wealth of techniques for tapping the enormous therapeutic potential of these molecules-providing a solid basis of knowledge for new drug design.
In response to the US FDA's Critical Path Initiative, innovative adaptive designs are being used more and more in clinical trials due to their flexibility and efficiency, especially during early phase development.
Since the publication of the bestselling first edition of CRC Desk Reference of Clinical Pharmacology, dramatic discoveries in molecular medicine along with rapid technological advances have revolutionized the diagnosis and resulted in new medications to be used in the treatment of a broad range of human diseases.
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.
The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.
The handling and analysis of data generated by proteomics investigations represent a challenge for computer scientists, biostatisticians, and biologists to develop tools for storing, retrieving, visualizing, and analyzing genomic data.
Connecting past, present, and future instrument development and use, Biocalorimetry: Foundations and Contemporary Approaches explores biocalorimetry's history, fundamentals, methodologies, and applications.
Furnishing the latest interdisciplinary information on the most important and frequently the only investigational system available for discovery programs that address the effects of small molecules on newly discovered enzyme and receptor targets emanating from molecular biology, this timely resource facilitates the transition from classical to high
Selecting illustrative examples from the recent literature, this reference studies the underlying principles and physics of a wide range of spectroscopic techniques utilized in the pharmaceutical sciences and demonstrates various applications for each method analyzed in the text-showing how knowledge of the mechanisms of spectroscopic phenomena may
Employing a wide range of examples from G-protein-coupled receptors and ligand-gated ion channels, this detailed, single-source reference illustrates the principles of pharmacological analysis and receptor classification that are the basis of rational drug design.
Moving rapidly from science fiction to science fact, cryopreservation is an integral part of many research, development, and production processes in industry and academia.
Completely revised and updated, Fluid Sterilization by Filtration, Third Edition discusses the use of gas and fluid filtration systems in sterilization technology.
Extensively revised and updated, Antisense Drug Technology: Principles, Strategies, and Applications, Second Edition reflects the logarithmic progress made in the past four years of oligonucleotide-based therapies, and, in particular, antisense therapeutics and research.
Completely revised text that reflects to emergent trends and cutting-edge advances in pharmaceutical biotechnology, this Third Edition provides a well-balanced framework for understanding every major aspect of pharmaceutical biotechnology, including drug development, production, dosage forms, administration, and therapeutic developments.
Focusing on group sequential procedures, summarizes the sequential statistical methods used in anticancer, antiviral, cardiovascular, and gastrointestinal drug research and screening.
Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide a valid inference about the objective of the trial.
Presenting breakthrough research pertinent to scientists in a wide range of disciplines-from medicine and biotechnology to cosmetics and pharmacy-this Second Edition provides practical approaches to complex formulation problems encountered in the development of particulate delivery systems at the micro- and nano-size level.
Exploring how to apply in vitro/in vivo correlations for controlled release dosage forms, Bioavailability of Drug Delivery Systems: Mathematical Modeling clearly elucidates this complex phenomena and provides a guide for the respective mathematical modeling.
Bayesian analyses have made important inroads in modern clinical research due, in part, to the incorporation of the traditional tools of noninformative priors as well as the modern innovations of adaptive randomization and predictive power.
Responding to the clear need for an immunology text written with the pharmacist and pharmaceutical scientist in mind, this volume highlights issues of particular relevance to pharmacy practice, including hypersensitivity reactions to natural allergens and pharmaceutical agents.
Critical in the elimination of drugs and other xenobiotics from the body, cytochrome P450 has strong bearing on scientific assessments of genetic polymorphism in metabolism, possible drug-drug interactions, and bioavailability of candidate drugs.
"e;Provides well-integrated, comprehensive coverage of all the major statistical designs and methods used for animal studies in pharmaceutical research and development.
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.
Site-specific drug delivery and targeting attracts much research interest from both academia and industry, but because of the many challenges faced in the development of these systems, only a handful of targeted therapies have successfully made it into clinical practice.
This reference features the latest findings surrounding the physicochemical aspects of surfactant and polymer systems to facilitate the design and understanding of novel and advanced drug delivery formulations.
Emphasizing the role of good statistical practices (GSP) in drug research and formulation, this book outlines important statistics applications for each stage of pharmaceutical development to ensure the valid design, analysis, and assessment of drug products under investigation and establish the safety and efficacy of pharmaceutical compounds.
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
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.
Pharmaceutical Isothermal Calorimetry discusses the application of isothermal calorimetric techniques to challenges encountered during the rational design and development of novel drugs and drug delivery systems.
Adaptive Designs for Sequential Treatment Allocation presents a rigorous theoretical treatment of the results and mathematical foundation of adaptive design theory.
