Generic Drug Product Development


Book Description

Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who need to demonstrate the therapeutic equivalence of generic specialty dru




Pathophysiology for the Health Professions - E- Book


Book Description

A concise, easy-to-understand introduction to the fundamentals, Pathophysiology for the Health Professions, 4th Edition helps you learn to identify disease processes and disorders. Authors Barbara Gould and Ruthanna Dyer continue the tradition of a text known for its readability and vivid, full-color illustrations, updated with the latest research and clinical advances. Unique Challenge, Think About, and Emergency Treatment features help in applying the material to real-life situations. No matter which area in the healthcare field you may enter, this book provides essential preparation for conditions encountered in clinical practice. Concise and readable approach includes the information students need without overwhelming them, even if they have a limited scientific background. Unique Challenge feature asks "What can go wrong with this structure or system?" as a way to help students facilitate progress by using previously learned knowledge. Unique Think About boxes help with self-evaluation, test preparation, and review. Unique Emergency Treatment boxes list basic emergency measures; these can be modified to fit specific professions, established protocols, or practice settings. Research boxes discuss new developments, problem areas of pathophysiology, and complications associated with research. Warning Signs boxes summarize conditions that may develop in patients. Diagnostic tests and treatments are included for each of the major disorders. Case studies in each chapter provide a basis for discussion or can be used as an assignment. Study questions offer a self-assessment on the material in each chapter. Ready References in the appendix provide a quick lookup for anatomic terms, conversion tables, abbreviations and acronyms, diagnostic studies and tests, and more. A companion Evolve website includes web links, learning activities, content updates, and more. New content on the causes and trends related to disease, new drugs, technology, and treatment. Coverage of obesity and its complications, including an in-depth discussion of metabolic syndrome. Multiple disorder syndromes in the aged client. DNA, genetics and the Human Genome Project with current research on protein pathways in health (proteomics) and the implications for drug treatment and disease causation. Coverage of autism. Updated content on the H1N1 virus and communicable diseases; HIV, cancer causation, and immunology; and substance abuse to reflect common practices in the use of illicit (street) drugs as well as abuse of prescription medications. Case studies revised to emphasize chronic diseases, prevention, and acute care, and to apply to a wider range of health professions. Appendices reorganized for improved reference and lookup.




Antipsychotics and their Side Effects


Book Description

With the remarkable expansion in the use of antipsychotics, concerns about their immediate, intermediate, and long-term adverse effects have intensified. Despite this, studies consistently show that monitoring of patients taking antipsychotics can be inadequate, haphazard, or worse. This book provides a comprehensive review of the adverse effects of this pharmacologically complex therapeutic class, covering all commonly used conventional and atypical agents. In the first section, each chapter provides background information about an adverse effect, reviews the evidence linking the effect to various antipsychotics, and provides specific detection and monitoring recommendations. The second section provides unique monitoring guides for each antipsychotic. The third section provides the clinician with a program to monitor patients over the long-term. By supporting rational treatment decisions and systematic adverse effect monitoring, Antipsychotics and their Side Effects provides the clinician with the necessary information and tools for optimizing the safe and effective long-term use of antipsychotic drugs.




Gibaldi's Drug Delivery Systems in Pharmaceutical Care


Book Description

Tying together concepts of traditional pharmaceutics in a way this text focuses on the selection of appropriate dosage forms as an integral part of drug therapy.




Immunisation against infectious diseases


Book Description

This is the third edition of this publication which contains the latest information on vaccines and vaccination procedures for all the vaccine preventable infectious diseases that may occur in the UK or in travellers going outside of the UK, particularly those immunisations that comprise the routine immunisation programme for all children from birth to adolescence. It is divided into two sections: the first section covers principles, practices and procedures, including issues of consent, contraindications, storage, distribution and disposal of vaccines, surveillance and monitoring, and the Vaccine Damage Payment Scheme; the second section covers the range of different diseases and vaccines.




Formulating Poorly Water Soluble Drugs


Book Description

This volume is intended to provide the reader with a breadth of understanding regarding the many challenges faced with the formulation of poorly water-soluble drugs as well as in-depth knowledge in the critical areas of development with these compounds. Further, this book is designed to provide practical guidance for overcoming formulation challenges toward the end goal of improving drug therapies with poorly water-soluble drugs. Enhancing solubility via formulation intervention is a unique opportunity in which formulation scientists can enable drug therapies by creating viable medicines from seemingly undeliverable molecules. With the ever increasing number of poorly water-soluble compounds entering development, the role of the formulation scientist is growing in importance. Also, knowledge of the advanced analytical, formulation, and process technologies as well as specific regulatory considerations related to the formulation of these compounds is increasing in value. Ideally, this book will serve as a useful tool in the education of current and future generations of scientists, and in this context contribute toward providing patients with new and better medicines.




The Chapter 800 Answer Book


Book Description

"Provides explanation of elements of USP Hazardous Drugs' Handling in Healthcare Settings and best practices to comply with the requirements and recommendations of the USP General Chapter"--Pref.




Rare Diseases and Orphan Products


Book Description

Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.




Human Pharmaceuticals, Hormones and Fragrances


Book Description

The observed concentrations of pharmaceuticals and personal care products (PPCPs) in raw wastewater confirm that municipal wastewater represents the main disposal pathway for the PPCPs consumed in households, hospitals and industry. In sewage treatment plant effluents most PPCPs are still present, since many of these polar and persistent compounds are being removed only partially or, in some cases, not at all. Treated wastewater therefore represents an important point source for PPCPs into the environment. After passing a sewage treatment plant the treated wastewater is mostly discharged into rivers and streams or sometimes used to irrigate fields. If drinking water is produced using resources containing a substantial proportion of treated wastewater (e.g. from river water downstream of communities) the water cycle is closed and indirect potable reuse occurs. Human Pharmaceuticals, Hormones and Fragrances provides an overview of the occurrence, analytics, removal and environmental risk of pharmaceuticals and personal care products in wastewater, surface water and drinking water. The book covers all aspects of the fate and removal of PPCPs in the whole water cycle: consumption and occurrence, analytical methods, the legal background, environmental risk assessment, human and animal toxicology, source control options, wastewater and drinking water treatment as well as indirect reuse. The book presents a summary of the results obtained during the EU project "Poseidon", combined with further expert knowledge on the field, and is written at a level appropriate for professionals involved in management of water resource quality. Professionals in the field including decision makers, engineers and scientists, as well as students entering the field, will find this an invaluable source of information. First comprehensive study on the assessment, fate and removal of pharmaceuticals and personal care products in wastewater and drinking water treatment. Emphasises the importance of micropollutants in the water cycle, provides methods for quantifying their fate and technologies for their removal.