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Pharmacometrics represents a strategy to optimize and rationalize decision-making process integrating information on drug behavior, pharmacological response, and disease progression both in the drug development phases and in their clinical use. Pharmacometrics focuses on characterizing the pharmacokinetic and pharmacodynamic behavior of one or several active ingredients through the development of mathematical and statistical models that allow characterizing both the average behavior in the population and the different sources of variability. Currently, pharmacometrics has transformed drug development and therapeutic use paradigm, which yield to the recognition by the main regulatory agencies (FDA, EMA, and PMDA).
This book comprehensively addresses the physics and engineering aspects of human physiology by using and building on first-year college physics and mathematics. Topics include the mechanics of the static body and the body in motion, the mechanical properties of the body, muscles in the body, the energetics of body metabolism, fluid flow in the cardiovascular and respiratory systems, the acoustics of sound waves in speaking and hearing, vision and the optics of the eye, the electrical properties of the body, and the basic engineering principles of feedback and control in regulating all aspects of function. The goal of this text is to clearly explain the physics issues concerning the human bod...
R.E. Nordon and K. Schindhelm, Introduction. -- L. Robb, A.G. Elefanty, and C.G. Begley, Transcriptional Control of Hematopoieses. -- R. Starr and N.A. Nicola, Cell Signaling by Hemopoietic Growth Factor Receptors. -- P.J. Simmons, D.N. Haylock, and J.-P. Lévesque, Influence of Cytokines and Adhesion Molecules on Hematopoietic Stem Cell Development. -- P.A. Rowlings, Allogeneic Hematopoietic Stem Cell Transplantation. -- U. Hahn and L.B. To, Autologous Stem Cell Transplantation. -- M.R. Vowels, Cord Blood Stem Cell Transplantation. -- S.R. Riddell, E.H. Warren, D. Lewinsohn, C. Yee, and P.D. Greenberg, Reconstitution of Immunity by Adoptive Immunotherapy with T Cells. -- L.Q. Sun, M. Miller, and G. Symonds, Exogenous Gene Transfer into Lymphoid and Hematopoietic Progenitor Cells. -- C. Dowding, T. Leemhuis, A. Jakubowski, and C. Reading, Process Development for Ex Vivo Cell Therapy. -- R.E. Nordon and K. Schindhelm, Cell Separation. -- P.W. Zandstra, C.J. Eaves, and J.M. Piret, Environ ...
The Vaccine Book, Second Edition provides comprehensive information on the current and future state of vaccines. It reveals the scientific opportunities and potential impact of vaccines, including economic and ethical challenges, problems encountered when producing vaccines, how clinical vaccine trials are designed, and how to introduce vaccines into widespread use. Although vaccines are now available for many diseases, there are still challenges ahead for major diseases, such as AIDS, tuberculosis, and malaria. This book is designed for students, researchers, public health officials, and all others interested in increasing their understanding of vaccines. It answers common questions regardi...
Nonclinical Safety Assessment Nonclinical Safety Assessment A Guide to International Pharmaceutical Regulations Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a p...
Worldwide economic constraints on health care systems have highlighted the importance of evidence-based medicine and evidence-based health policy. The resulting clinical trials and health services research studies require instruments to monitor the outcomes of care and the output of the health system. However, the over-abundance of competing measurement scales can make choosing a measure difficult at best. Measuring Health provides in-depth reviews of over 100 of the leading health measurement tools and serves as a guide for choosing among them.LNow in its third edition, this book provides a critical overview of the field of health measurement, with a technical introduction and discussion of...
Neurodegenerative disorders, such as Alzheimer's and Parkinson's disease are a growing burden on our society. Understanding and treating these common diseases is one of the major current challenges for the biomedical field. In Neurodegeneration: Methods and Protocols, experts in the field tackle this challenge and present cutting-edge analytical and technological approaches to study the mechanisms underlying neurodegenerative processes. Organizes into five sections, chapters detail protocols for isolating and culturing cells from the nervous system, production and use of animal models, characterization of cell death, analytical tools to study disease mechanisms, and therapeutic approaches for neurodegeneration. Written in the successful Methods in Molecular BiologyTM series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible protocols, and notes on troubleshooting and avoiding known pitfalls. Authoritative and easily accessible, Neurodegeneration: Methods and Protocols serves as an ideal guide to both novice and professional researchers in the field of neurodegeneration.