Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials gives a thorough presentation of state-of-the-art methods for early phase clinical trials.
Bioreactors: Animal Cell Culture Control for Bioprocess Engineering presents the design, fabrication, and control of a new type of bioreactor meant especially for animal cell line culture.
Bioreactors: Animal Cell Culture Control for Bioprocess Engineering presents the design, fabrication, and control of a new type of bioreactor meant especially for animal cell line culture.
Clinical Trial Optimization Using R explores a unified and broadly applicable framework for optimizing decision making and strategy selection in clinical development, through a series of examples and case studies.
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.
Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products.
Written specifically for biotechnology scientists, engineers, and quality professionals, this book describes and demonstrates the proper application of statistical methods throughout Chemistry, Manufacturing, and Controls (CMC).
Cluster Randomised Trials, Second Edition discusses the design, conduct, and analysis of trials that randomise groups of individuals to different treatments.
Properties and Formulation: From Theory to Real-World ApplicationScientists have attributed more than 40 percent of the failures in new drug development to poor biopharmaceutical properties, particularly water insolubility.
The advances in drug delivery systems over recent years have resulted in a large number of novel delivery systems with the potential to revolutionize the treatment and prevention of diseases.
All the Essentials to Start Using Adaptive Designs in No TimeCompared to traditional clinical trial designs, adaptive designs often lead to increased success rates in drug development at reduced costs and time.
Since the discovery of Aquaporin-1 (AQP1) as a water channel, many studies have revealed the importance of aquaporins in mammalian physiology and pathophysiology as well as plant and microbial biology.
The emergence of nanotherapeutics is attributable to the integration of nanotechnology, recombinant DNA technology, and synthetic organic chemistry with medicine for treating critical human diseases in a more efficient and specific molecular approach than therapy with conventionally-designed and formulated drugs.
Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis provides statisticians with an understanding of the critical challenges currently encountered in oncology trials.
Reliably optimizing a new treatment in humans is a critical first step in clinical evaluation since choosing a suboptimal dose or schedule may lead to failure in later trials.
Since the completion of the first edition of this book, major developments have occurred in the pharmaceutical industry that have shaped the field of near-infrared (NIR) spectroscopy.
The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product should be based upon a thorough understanding of both the product and the manufacturing process.
Develop Effective Immunogenicity Risk Mitigation StrategiesImmunogenicity assessment is a prerequisite for the successful development of biopharmaceuticals, including safety and efficacy evaluation.
Handbook of Medicinal Plants of the World for Aging: Botany, Ethnopharmacology, Natural Products, and Molecular Pathways provides an unprecedented comprehensive overview of more than 100 plants used globally as medicine with the potential to prevent premature aging.
This book comprehensively explores Asian Cobras, covering their evolutionary history, geographic distribution, venom characteristics, pathophysiology of envenomation, and treatment strategies.
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.
This textbook has been written primarily for undergraduate students of pharmacy, toxicology, and medicine who require a concise reference book on basic endocrine function and dysfunction.
This text is aimed at potential clinical investigators usually physicians, especialy those thinking about doing clinical trials to evaluate new drugs - mostly sponsored by pharmaceutical companies.
Now the adverse drug reaction events reported in the newsletter Clin-Alert during Y2000 have been compiled, organized, re-formatted, indexed, and published in a convenient one-volume reference book, Clin-Alert 2001.
Focusing on how the radiation process works and how it is applied in sterilizing medical devices and healthcare products, Radiation Sterilization for Health Care Products covers recent developments in radiation technology such as e-beams, gamma rays, and x-rays.
Focusing on group sequential procedures, summarizes the sequential statistical methods used in anticancer, antiviral, cardiovascular, and gastrointestinal drug research and screening.
"e;Provides well-integrated, comprehensive coverage of all the major statistical designs and methods used for animal studies in pharmaceutical research and development.
This text traces developments in rational drug discovery and combinatorial library design with contributions from 50 leading scientists in academia and industry who offer coverage of basic principles, design strategies, methodologies, software tools and algorithms, and applications.
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.
Get Up to Speed on Many Types of Adaptive DesignsSince the publication of the first edition, there have been remarkable advances in the methodology and application of adaptive trials.
