Sustained-Release Injectable Products focuses on the development process for sustained-release versions of drugs and delivery systems and administration routes. From the rationale and basic product development principles to regulatory issues and the approval process, expert contributions address virtually every aspect. They bring together common threads that apply to any sustained-release formulation, such as scale-up, safety, biocompatibility, analytical challenges, and quality assurance.
This book covers the principles of cryopreservation as they relate the preservation of viable cells and cell materials being developed for biopharmaceutical applications. Topics include: the principles of freezing and thawing cells, physiochemical phenomena, process and system design options, method selection considerations, preservation procedures, cryoprotectant additives, freeze-drying human live virus vaccines, and transport system selection criteria. Contributions from well-known experts such as Steven S. Lee, Thomas C. Pringle, William H. Siegel, Richard Wisniewski, and Fangdong Yin make this the single most important study available.
Written by the founders of the Institute of Validation, this introduction to validation cuts through all the jargon and focuses on the essentials. Valuable to novices and experienced validators alike, this book helps readers understand validation fundamentals and how these principles can help build the highest quality into products. The authors address associated costs, responsibilities, policies, strategies, support activities, SOPs, Master Plans, and other related subjects. The book also provides tools that support understanding the logic behind the validation process and covers testing, certification, protocols, final reports, sign-offs, and ways to create seamless audit trails.
This guidebook provides proven methods and techniques for performing effective audits that serve your department, your company, and you. Topics covered relate to the four key competencies essential for successful GMP audits. Includes the rationale for auditing as an important quality tool, along with the audit cycle, broken into five distinct phases. To focus the power of auditing on a particular situation, several different types of audits are presented, as are more than a dozen audit approaches with general questions to answer and specific items to examine. These tools will help you prepare checklists and standards so audits become more effective, consistent, and standardized. The book includes profiles of seasoned professionals in drug and device auditing, who share their experiences (the good and the bad)!
The Blood-Brain Barrier and Its Microenvironment
Spinal Reconstruction
Crystal-Induced Arthropathies
Genetics of Asthma and Chronic Obstructive Pulmonary Disease
Guiding clinicians toward the most effective treatment regimens. This book offers an coverage of the symptomatology, diagnosis, epidemiology, and etiology of depression. It reviews research and clinical data regarding acute and long-term outcomes, combination therapies, neuroimaging, genetics, and pharmacologic and psychotherapeutic measures.
Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance.
Providing a thorough review of automated systems testing to meet the regulatory requirements of the FDA and MCA, this title focuses on software module, software integration, hardware, and system acceptance testing. It covers best practices in computer systems testing for the pharmaceutical and related healthcare manufacturing industries.
Written especially for the pharmaceutical industry professional, this volume addresses each part of the life-cycle of engineering change control. It covers issues in the EU and US and describes the operational requirements and responsibilities that ensure change controls are effectively applied and recorded.
Including coverage of systemic osteoporosis induced by steroid use, this collection of essays focuses on basic and clinical essentials of osteoporosis and the latest orthopaedic findings in applied research and surgical treatment.
Focusing on a traditionally less studied age group, that of prepubertal children, this book presents concentrated and selected information about the relationship among health and anthropometry, physical activity, motor ability, and motor development in children between the ages of eight and twelve.
Reveals the results from clinical trials conducted in Scandinavia, Scotland, Australia, Canada, and the United States. This book highlights historical studies of dietary trials designed to reduce CHD; covers tests of HMG COA reductase inhibitors for patients with and without CHD; and more. It is for cardiologists, pharmacologists, and others.
Performing an study of one of the common yet less accurately understood causes of human illness. This book examines the epidemiology, pathophysiology, and treatment options for asthma and respiratory infections. It contains results from clinical trials of antiviral agents that explore avenues of therapy.
Summarizes the etiology, presentation, and treatment of the complex symptoms, infections, and opportunistic cancers of people living with HIV/AIDS. This book presents therapies that strike a balance between controlling and eliminating cancer and minimizing the damage to the immune system. It is for oncologists, immunologists, and others.
Explains pharmaceutical transport phenomena. This book focuses on practical applications of drug delivery from a physical and mechanistic perspective, highlighting biological systems. It demonstrates applications like drug or nutrient uptake into vesicle or cell suspensions, drug dissolution and absorption across biological membranes and others.
Highlights the impact of sleep deprivation on the well-being of the individual and society. This reference presents theories on the function of sleep, the effects of sleep deprivation on patients with medical and psychiatric conditions, and provides interpretative and methodological results in comparative studies of sleep deprivation.
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