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Designed with the distinctive, user-friendly presentation Dr Stahl's audience know and love, this new stream of Stahl books capitalize on Dr Stahl's greatest strength - the ability to address complex issues in an understandable way and with direct relevance to the everyday experience of clinicians. The book describes a wide-ranging and representative selection of clinical scenarios, making use of icons, questions/answers and tips. It follows these cases through the complete clinical encounter, from start to resolution, acknowledging all the complications, issues, decisions, twists and turns along the way. The book is about living through the treatments that work, the treatments that fail, and the mistakes made along the journey. This is psychiatry in real life - these are the patients from your waiting room - this book will reassure, inform and guide better clinical decision making.
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Safety Evaluation of Pharmaceuticals and Medical Devices has been written to provide complete, ready and clear guidance as to what nonclinical safety assessment tests need to be performed to move a regulated therapeutic medical product into and through the development process and to marketing approval. This intent is purposely extended to cover the closely related product types of vaccines, biotechnology products, gene therapy, cell therapy, and combination products into a single, concise guide for the process in all the major world market countries. The approach of this volume is to first address the broadest scope general case for the regulatory nonclinical safety evaluation by ICH and ISO adhering countries, then to branch out to cover the differences in requirements associated with specific therapeutic areas (such as oncology), major routes of administration (with oral being the general case, other routes starting with parentheral, dermal and inhalation are addressed). Large molecules biotechnology products are then considered, followed by special courses of product marketing approval, and finally the remaining national differences.
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Since its publication in 2006, Pharmacokinetic-Pharmacodynamic Modeling and Simulation has become the leading text on modeling of pharmacokinetic and pharmacodynamic data using nonlinear mixed effects models and has been applauded by students and teachers for its readability and exposition of complex statistical topics. Using a building block approach, the text starts with linear regression, nonlinear regression, and variance models at the individual level and then moves to population-level models with linear and nonlinear mixed effects models. Particular emphasis is made highlighting relationships between the model types and how the models build upon one another. With the second edition, new chapters on generalized nonlinear mixed effects models and Bayesian models are presented, along with an extensive chapter on simulation. In addition, many chapters have been updated to reflect recent developments. The theory behind the methods is illustrated using real data from the literature and from the author's experiences in drug development. Data are analyzed using a variety of software, including NONMEM, SAS, SAAM II, and WinBUGS. A key component of the book is to show how models are developed using an acceptance-rejection paradigm with the ultimate goal of using models to explain data, summarize complex experiments, and use simulation to answer "what-if" questions. Scientists and statisticians outside the pharmaceutical sciences will find the book invaluable as a reference for applied modeling and simulation.
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Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined. As these processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: Methods in Clinical Pharmacology".
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Negli ultimi anni la Farmacognosia ha conosciuto una grande evoluzione grazie a nuove tecniche e a nuovi strumenti d'indagine. In particolare si sono notevolmente ampliate le conoscenze scientifiche sulle piante medicinali. Tali nozioni chimiche, botaniche e farmacologiche sono raccolte in quest'opera rivolta non solo agli studenti, ai farmacisti, ai medici e agli erboristi, ma anche ai fitochimici e ai farmacologi impegnati nelle università e nelle industrie farmaceutiche. La nuova edizione conserva la struttura della precedente ma ne aggiorna profondamente i contenuti. Particolare attenzione è stata dedicata all'impiego terapeutico e agli effetti indesiderati delle diverse droghe vegetali. Un formulario fitoterapico, un indice terapeutico e un vasto apparato iconografico arricchiscono il volume in modo chiaro ed esauriente. In questa versione rinnovata i lettori possono trovare l'opera di Farmacognosia più completa e moderna oggi disponibile.
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