Download or read book Handbook of Pharmaceutical Manufacturing Formulations Third Edition written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2019-12-06 with total page 593 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume One, Compressed Solid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this first volume of a six-volume set, compiles data from FDA new drug applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of GMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent.
Download or read book Fluoxetine written by Graziano Pinna and published by . This book was released on 2015-04-01 with total page 412 pages. Available in PDF, EPUB and Kindle. Book excerpt: Fluoxetine, best known by the trade name Prozac®, unlike other psychotropic drugs whose effects were serendipitously stumbled upon, was the first developed for a precise mechanism of action, that is, the ability to selectively inhibit serotonin reuptake, based upon the theory that increasing the availability of serotonin would treat major depression. Once approved by the FDA in 1987, fluoxetine quickly became the most prescribed psychotropic drug worldwide and its success in improving mood disorders has triggered the development of a large number of congener molecules, commonly known as SSRIs after their purported mechanism of action. However, a quarter of a century after its development, the idea that fluoxetine asserts its positive behavioral effect through inhibition of serotonergic reuptake is not firmly established. This book reviews several preclinical and clinical reports suggesting that the pharmacological effects of fluoxetine may be mediated by means other than the regulation of serotonin, including the regulation of gene expression, modifying epigenetic mechanisms as well as modifying microRNAs. One of the most prominent mechanisms for the therapeutic relevance of fluoxetine relates to influencing neuroplasticity by enhancing neurotropic factors, including BDNF signaling and altering adult neurogenesis. The ability of fluoxetine to rapidly increase neurosteroid levels accounts for the fast anxiolytic effects of this drug. Fluoxetine action at sigma-1 receptor or modulating glutamatergic neurotransmission as well as the combination of fluoxetine with other psychotropic drugs is discussed in relation to its therapeutic effects. While fluoxetine was primarily prescribed as an antidepressant, this drug currently represents a treatment of choice for a broad spectrum of psychiatric disorders, including post-traumatic stress disorder and a range of anxiety disorders. This drug even possesses analgesic actions and is a valuable therapy for stroke. This book also highlights emerging evidence on the gender-specific effects of fluoxetine, its potential adverse features, including its addiction liability in combination with psychostimulants, and the impact of perinatal fluoxetine exposure.
Download or read book Pediatric Cardiac Surgery written by Constantine Mavroudis and published by John Wiley & Sons. This book was released on 2023-01-19 with total page 1124 pages. Available in PDF, EPUB and Kindle. Book excerpt: Der Bereich der pädiatrischen Herz- und Gefäßchirurgie umfasst nicht nur die Herzchirurgie bei Säuglingen und Kindern, sondern auch die Herzchirurgie bei Erwachsenen zur Korrektur von angeborenen Herzfehlern. Da die Kindersterblichkeit aufgrund von Herzfehlern zurückgeht und Patienten mit angeborenen Herzfehlern zunehmend ein langes, gesundes Leben führen, ergeben sich neue Herausforderungen. Somit war der Bedarf an Einführungen in diesen lebensrettenden Bereich noch nie so groß. Pediatric Cardiac Surgery ist ein gut verständliches, umfassendes Lehrbuch, das diesen Bedarf seit über dreißig Jahren erfüllt und von Fachleuten auf allen Ebenen genutzt wird. Das Lehrwerk, das zahlreiche farbige Abbildungen enthält, bietet zunächst eine wissenschaftliche Einführung in die kardiovaskuläre Entwicklung und dann detaillierte Analysen von Defekten in verschiedenen Bereichen des Herzens mit den entsprechenden Verfahren zur Korrektur dieser Defekte. Die aktualisierte fünfte Auflage berücksichtigt die neuesten wissenschaftlichen Erkenntnisse und bleibt damit ein unverzichtbares Werk zu diesem Thema. Die fünfte Auflage von Pediatric Cardiac Surgery enthält unter anderem: * Beiträge von über 75 nationalen und internationalen Experten auf dem Gebiet * Beeindruckende anatomische Illustrationen von Rachid Idriss * Neue Kapitel, in denen der neueste Stand der Forschung dargestellt wird, sowie neue Inhalte in Bezug auf die kardiale Bildgebung und die medizinische Ausbildung Pediactric Cardiac Surgery ist ein wichtiges Nachschlagewerk für Herzchirurgen, die sich auf Kinder und Erwachsene spezialisiert haben, Kardiologen und alle medizinischen Fachkräfte, die mit pädiatrischen oder erwachsenen Herzpatienten arbeiten.
Download or read book Approved Prescription Drug Products written by and published by . This book was released on 1984 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accompanied by supplements.
Download or read book Making Medicines Affordable written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-03-01 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.
Download or read book Generic drug entry prior to patent expiration an FTC study written by and published by DIANE Publishing. This book was released on 2002 with total page 129 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Microsized and Nanosized Carriers for Nonsteroidal Anti Inflammatory Drugs written by Bojan Čalija and published by Academic Press. This book was released on 2017-01-03 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: Microsized and Nanosized Carriers for Nonsteroidal Anti-Inflammatory Drugs: Formulation Challenges and Potential Benefits provides a unique and complete overview of novel formulation strategies for improvement of the delivery of NSAIDs via encapsulation in microsized and nanosized carriers composed of different materials of natural and synthetic origin. This book presents the latest research on advances and limitations of both microsized and nanosized drug carriers and NSAIDs before discussing the formulation aspects of these drug carriers that are intended for oral, dermal, and transdermal administration of NSAIDs. In addition, functionality of these materials as potential excipients for microsized and nanosized carriers is discussed and debated. Practical solutions for improving effectiveness of these drugs are included throughout the book, making this an important resource for graduate students, professors, and researchers in the pharmaceutical sciences. Covers a wide range of microsized and nanosized carriers in one resource, including particulate carriers (microparticles, nanoparticles, and zeolites) and the soft colloidal carriers, such as micro-emulsions and nano-emulsions Presents the reader with various formulation approaches dependent on the characteristics of the material, model drug, and desired route of administration Approaches are based on the latest research in the area and formulation strategies may have broader applications to the encapsulation of other active pharmaceutical ingredients
Download or read book Improving and Accelerating Therapeutic Development for Nervous System Disorders written by Institute of Medicine and published by National Academies Press. This book was released on 2014-02-06 with total page 107 pages. Available in PDF, EPUB and Kindle. Book excerpt: Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.
Download or read book Library of Congress Subject Headings written by Library of Congress and published by . This book was released on 2006 with total page 1536 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Population Sciences written by and published by . This book was released on 1974 with total page 754 pages. Available in PDF, EPUB and Kindle. Book excerpt: The index is based on citations selected from the corresponding monthly issue of Index medicus.
Download or read book Anesthetic Pharmacology written by Alex S. Evers and published by Cambridge University Press. This book was released on 2011-03-10 with total page 2902 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years our understanding of molecular mechanisms of drug action and interindividual variability in drug response has grown enormously. Meanwhile, the practice of anesthesiology has expanded to the preoperative environment and numerous locations outside the OR. Anesthetic Pharmacology: Basic Principles and Clinical Practice, 2nd edition, is an outstanding therapeutic resource in anesthesia and critical care: Section 1 introduces the principles of drug action, Section 2 presents the molecular, cellular and integrated physiology of the target organ/functional system and Section 3 reviews the pharmacology and toxicology of anesthetic drugs. The new Section 4, Therapeutics of Clinical Practice, provides integrated and comparative pharmacology and the practical application of drugs in daily clinical practice. Edited by three highly acclaimed academic anesthetic pharmacologists, with contributions from an international team of experts, and illustrated in full colour, this is a sophisticated, user-friendly resource for all practitioners providing care in the perioperative period.
Download or read book Interagency Coordination in Drug Research and Regulation Testimony and exhibits including subsequent correspondence on 1 Commission on Drug safety 2 Pharmaceutical Manufacturers Association 3 Medical education on drug therapy and other drug issues written by United States. Congress. Senate. Committee on Government Operations and published by . This book was released on 1964 with total page 728 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pharmacometrics written by Ene I. Ette and published by John Wiley & Sons. This book was released on 2013-03-14 with total page 1236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmacometrics is the science of interpreting and describing pharmacology in a quantitative fashion. The pharmaceutical industry is integrating pharmacometrics into its drug development program, but there is a lack of and need for experienced pharmacometricians since fewer and fewer academic programs exist to train them. Pharmacometrics: The Science of Quantitative Pharmacology lays out the science of pharmacometrics and its application to drug development, evaluation, and patient pharmacotherapy, providing a comprehensive set of tools for the training and development of pharmacometricians. Edited and written by key leaders in the field, this flagship text on pharmacometrics: Integrates theory and practice to let the reader apply principles and concepts. Provides a comprehensive set of tools for training and developing expertise in the pharmacometric field. Is unique in including computer code information with the examples. This volume is an invaluable resource for all pharmacometricians, statisticians, teachers, graduate and undergraduate students in academia, industry, and regulatory agencies.
Download or read book Library of Congress Subject Headings written by Library of Congress. Cataloging Policy and Support Office and published by . This book was released on 2003 with total page 1418 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Dose Finding in Drug Development written by Naitee Ting and published by Springer Science & Business Media. This book was released on 2006-12-29 with total page 262 pages. Available in PDF, EPUB and Kindle. Book excerpt: If you have ever wondered when visiting the pharmacy how the dosage of your prescription is determined this book will answer your questions. Dosing information on drug labels is based on discussion between the pharmaceutical manufacturer and the drug regulatory agency, and the label is a summary of results obtained from many scientific experiments. The book introduces the drug development process, the design and the analysis of clinical trials. Many of the discussions are based on applications of statistical methods in the design and analysis of dose response studies. Important procedural steps from a pharmaceutical industry perspective are also examined.
Download or read book Generic Drug Entry Prior to Patent Expiration written by United States. Federal Trade Commission and published by . This book was released on 2002 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: In April 2001, the Commission began an industry-wide study focused on certain aspects of generic drug competition under the Hatch-Waxman Amendments. The Amendments provide certain methods by which generic drug manufacturers can obtain approval to market a generic version of a brand-name product. The study's purpose was to provide a more complete picture of how generic drug competition has developed under one method the Amendments established: generic entry prior to expiration of the brand-name company's patents on the relevant drug product.
Download or read book Current Catalog written by National Library of Medicine (U.S.) and published by . This book was released on 1993 with total page 824 pages. Available in PDF, EPUB and Kindle. Book excerpt: First multi-year cumulation covers six years: 1965-70.
