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The Nonhuman Primate in Drug Development and Safety Assessment is a valuable reference dedicated to compiling the latest research on nonhuman primate models in nonclinical safety assessment, regulatory toxicity testing and translational science. By covering important topics such as study planning and conduct, inter-species genetic drift, pathophysiology, animal welfare legislation, safety assessment of biologics and small molecules, immunotoxicology and much more, this book provides scientific and technical insights to help you safely and successfully use nonhuman primates in pharmaceutical toxicity testing. A comprehensive yet practical guide, this book is intended for new researchers or pr...
Pharmacology, Biology, and Clinical Applications of AndrogensCurrent Status and Future Prospects Edited by Shalender Bhasin, Henry L. Gabelnick, Jeffrey M. Spieler,Ronald S. Swerdloff, Christina Wang, and Chuck Kelly As agents that affect the male primary and accessory sex organs,androgens--particularly the hormones testosterone andandrosterone--play a critical role in the development,functionality, and overall health of the male reproductive system.However, since androgens also have far-ranging effects onmetabolism, neurological activity, and behavior, scientistsexploring the contraceptive or therapeutic potential of androgensneed reliable, up-to-date information on the complex biologicalac...
New developments in testosterone therapy are summarized here by internationally renowned experts. They review both basic and clinical knowledge in fourteen chapters. The book begins with the biochemistry of testosterone, its biosynthesis, metabolism and mechanisms of action in target organs. Three chapters deal with specific aspects of testosterone action, namely its role in spermatogenesis, its psychotropic effects and its effects on bones. Syndromes caused by androgen resistance are described in order to highlight the importance of properly functioning enzymes and receptors in the target organs. Causes and symptoms of male hypogonadism, the major indication for testosterone treatment, are described. Five chapters are devoted to the pharmacology, pharmacokinetics and clinical uses and abuses of testosterone preparations. The new transdermal testosterone application is described in detail. Side effects of testosterone treatment are reviewed. The possible role of androgens in the development of prostatic hypertrophy and carcinoma is discussed extensively since this question is of major concern to the clinician.
In continuation of the Covance Primate Symposium Series, the 19th Covance Primate Symposium took place in Münster on 23rd & 24th of May 2012. Altogether, 70 participants representing 43 organisations, gathered for this symposium. The 2012 Primate Symposium focussed on ?Challenges in Nonhuman Primate Research in the 21st Century?. The broad participation and the lively discussions during the symposium underlined the timeliness and importance of this topic. Expert speakers covered four major topics, i.e. biosimilars development: regulatory implications, key considerations and next steps, optimizing nonhuman primate use in nonclinical safety assessment, trends in nonhuman primate developmental...
The search for a reversible male contraceptive has centered upon the suppression of sperm production or sperm motility. Gossypol, a natural substance extracted from the cotton plant, appears to cause both of these effects. Its ability to reduce spermatogenesis in men is undeniable and has been demonstrated in both large studies in China and a smaller confirmatory study in Brazil. These investiga tions have revealed the remarkable fact that with gossypol, it is possible to separate an effect on the testis' gamete-producing function from an effect on its hormone-producing function. Thus, it is possible to maintain normal testosterone levels and libido while sperm counts (and motility) fall. Be...
"The goal is to provide a comprehensive reference book for the preclinicaldiscovery and development scientist whose responsibilities span target identification, lead candidate selection, pharmacokinetics, pharmacology, and toxicology, and for regulatory scientists whose responsibilities include the evaluation of novel therapies." —From the Afterword by Anthony D. Dayan Proper preclinical safety evaluation can improve the predictive value, lessen the time and cost of launching new biopharmaceuticals, and speed potentially lifesaving drugs to market. This guide covers topics ranging from lead candidate selection to establishing proof of concept and toxicity testing to the selection of the fi...
This book provides a comprehensive study of the Leydig cell, a fascinating and important cell type. It presents all of the developments in our understanding of Leydig cell biology and explores a wide variety of current and potential clinical applications. All aspects of Leydig cell biology, development, regulation, and physiology are explored in thirty-one expertly written chapters. This in-depth volume is an invaluable resource.
The decade that has passed since publication of the second edition of this textbook has not only witnessed a tremendous increase in knowledge within the ? eld of and- logy, but also seen the ? eld itself achieve a newfound status within the medical p- fession. Knowledge and status have been of mutual bene? t to the ? eld and the growing critical mass of diagnostic and therapeutic possibilities have caused andrology to be recognized as a medical subspecialty in some countries such as Germany, Poland, and Estonia. The European Academy of Andrology (EAA) served as a pacemaker for this development and continues to strive for establishment of andrology as a clinical ? eld. Well-designed curricula...
Recent progress in recombinant DNA technology and the availability of a number of nonpeptide subtype-specific receptor antagonists and of specific antibodies to components of prorenin-renin-angiotensin system (PRAS) have led to rapid advances in the under standing of the multifaceted role of angiotensin II, classically known as a peptide hormone of cardiovascular homeostasis. Accumulating evidence sug responsible for the regulation gests that, in addition to its role in salt and water metabolism, PRAS may control other physiological functions including neurosecretion, cellular proliferation, hypertrophy and/or differentiation, angiogenesis and gonadal function. At the same time, it is becomi...