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WHO Expert Committee on Biological Standardization
"The WHO Expert Committee on Biological Standardization (ECBS) met in Geneva from 18 to 22 October 2010"--Introduction.
Current Catalog
First multi-year cumulation covers six years: 1965-70.
Animal Cell Technology: Developments towards the 21st Century
Animal cell technology is a discipline of growing importance, which aims not merely at understanding structure, function and behaviour of differentiated animal cells, but especially at the development of their abilities useful for clinical application. Topics of interest in this regard include: viral vaccines, pharmaceutical proteins and novel applications such as gene therapy and organ culture. Undoubtedly, these Proceedings of the joint Meeting of the European Society for Animal Cell Technology and the Japanese Association for Animal Cell Technology (Veldhoven, The Netherlands, September 1994) review the most recent status of the field, and will be most valuable to anyone actively involved...
Safe and Effective Medicines for Children
The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.
Validation of Pharmaceutical Processes
Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va
Treatment of Inflammatory Bowel Disease with Biologics
This book is a concise yet comprehensive overview of the use of biologics for the treatment of Crohn’s disease and ulcerative colitis. The volume details how best to utilize these medications in order to optimize their efficacy and safety, as well as how to understand, recognize, and treat complications that may arise from using biologics to treat IBD. The text also focuses on new data, novel biologics, and biosimilars of this rapidly expanding field. Written by experts in the field, Treatment of Inflammatory Bowel Disease with Biologics is a valuable resource for gastroenterologists, allied health professionals, fellows, and trainees who treat patients with inflammatory bowel disease.
Biologics, Biosimilars, and Biobetters
A comprehensive primer and reference, this book provides pharmacists and health practitioners the relevant science and policy concepts behind biologics, biosimilars, and biobetters from a practical and clinical perspective. Explains what pharmacists need to discuss the equivalence, efficacy, safety, and risks of biosimilars with physicians, health practitioners, and patients about Guides regulators on pragmatic approaches to dealing with these drugs in the context of rapidly evolving scientific and clinical evidence Balances scientific information on complex drugs with practical information, such as a checklist for pharmacists
Handbook of Biologics & Biosimilars in Dermatology
A drug is typically manufactured through chemical synthesis, which means that it is made by combining specific chemical ingredients in an ordered process. Biologics are medicines made from living cells through highly complex manufacturing processes and must be handled and administered under carefully monitored conditions. Biologics are used to prevent, treat, diagnose, or cure a variety of diseases including cancer, chronic kidney disease, autoimmune disorders, and infectious diseases. A biosimilar is a biologic that is similar to another biologic drug already that has already been approved. This book is a complete guide to the use of biologics and biosimilars in the treatment of dermatologi...
Infections Related to Biologics An Issue of Infectious Disease Clinics of North America
In collaboration with Consulting Editor Dr. Helen Boucher, Drs. Aruna Subramanian and Dora Yuk-Wai Ho have created an extremely timely and relevant issue for infectious disease physcians, as the field of biologics is exploding. These new agents are being used in rheumatologic diseases, hematologic malignancies, solid tumors, and other conditions; there is a lack of guidance in the literature on how to address their infectious risks. The first 9 articles explain the mechanisms of action of the biologic agents and the infectious disease risks associated with their immune system targets. The last few articles go into more depth on the viral, fungal, and mycobacterial infections that are potenti...
