Download or read book Oral Bioavailability Assessment written by Ayman F. El-Kattan and published by John Wiley & Sons. This book was released on 2017-06-06 with total page 452 pages. Available in PDF, EPUB and Kindle. Book excerpt: Specifically geared to personnel in the pharmaceutical and biotechnology industries, this book describes the basics and challenges of oral bioavailability – one of the most significant hurdles in drug discovery and development. • Describes approaches to assess pharmacokinetics and how drug efflux and uptake transporters impact oral bioavailability • Helps readers reduce the failure rate of drug candidates when transitioning from the bench to the clinic during development • Explains how preclinical animal models – used in preclinical testing – and in vitro tools translate to humans, which is an underappreciated and complicated area of drug development • Includes chapters about pharmacokinetic modelling, the Biopharmaceutics Drug Disposition Classification System (BDDCS), and the Extended Clearance Classification System (ECCS) • Has tutorials for applying strategies to medicinal chemistry practices of drug discovery/development
Download or read book Assessing Oral Bioavailability of Metals in Soil written by Mark E. Kelley and published by . This book was released on 2002 with total page 144 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book also illustrates how bioavailability adjustments can be incorporated into risk assessments to generate risk-based cleanup values that are more site specific than those based on the default assumption of complete bioavailability. Although the book focuses on oral bioavailability of metals to human receptors, many of the basic principles described herein also can be applied to assessing bioavailability of organic compounds and for assessing bioavailability to ecological receptors."--BOOK JACKET.
Download or read book Oral Drug Absorption written by Jennifer B. Dressman and published by CRC Press. This book was released on 2016-04-19 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Oral Drug Absorption, Second Edition thoroughly examines the special equipment and methods used to test whether drugs are released adequately when administered orally. The contributors discuss methods for accurately establishing and validating in vitro/in vivo correlations for both MR and IR formulations, as well as alternative approaches for MR an
Download or read book Oral Drug Absorption written by Jennifer B. Dressman and published by CRC Press. This book was released on 2000-06-06 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: A practical, hands-on guide for successfully developing oral drug products, this comprehensive reference runs the gamut from theoretical stages of computer-based calculations to practical guidelines for establishing in vitro/in vivo correlations. Coverage details the interrelationship between the physiology of the gastrointestinal tract and oral drug formulations and absorption, and progresses to the latest applications of pharmacokinetic analysis. Includes chapters by the innovators of the Biopharmaceutical Classification Scheme (BCS), human perfusions, and biorelevant dissolution testing! With over 600 literature references, equations, drawings, and photographs, Oral Drug Absorption offers multiple methods for predicting permeability, solubility, and dissolution for oral bioavailability and bioequivalence facilitates selection of appropriate drug candidates for development fully elaborates on the experimental and data analysis techniques of in vitro/in vivo correlations provides guidance to the Federal Drug Administration's BCS and its applications appends helpful case studies to the concepts discussed and much more! Contributions by more than 20 international specialists on the latest research make Oral Drug Absorption an invaluable tool and useful reference in the hands of pharmaceutical scientists, medicinal chemists, pharmacists, pharmacologists, toxicologists, biochemists, gastroenterologists, regulatory personnel, and graduate school students in these disciplines.
Download or read book How Can Information on Oral Bioavailability Improve Human Health Risk Assessment for Lead contaminated Soils written by A. G. Oomen and published by . This book was released on 2006 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Drug Discovery and Evaluation Methods in Clinical Pharmacology written by H.Gerhard Vogel and published by Springer Science & Business Media. This book was released on 2010-12-15 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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".
Download or read book Revising Oral Pharmacokinetics Bioavailability and Bioequivalence Based on the Finite Absorption Time Concept written by Panos Macheras and published by Springer Nature. This book was released on 2023-01-01 with total page 137 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book casts new light on the field of oral drug absorption. It outlines both the concept of the past and the novel concept of Finite Absorption Time (FAT). In addition, the authors explore the correlated need for re-definition of bioavailability, bioequivalence providing a plethora of experimental data. Accordingly, this book is intended for academics/students or scientists working in pharmaceutical industries, regulatory agencies, and contract research organizations. It can be used for teaching purposes in under- and post-graduate courses dealing with biopharmaceutics, pharmacokinetics and biomedical engineering.
Download or read book Guidance for Evaluating the Oral Bioavailability of Metals in Soils for Use in Human Health Risk Assessment written by United States. Environmental Protection Agency. Office of Solid Waste and Emergency Response and published by . This book was released on 2007 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Bioavailability in Environmental Risk Assessment written by Weiping Chen and published by CRC Press. This book was released on 1995-11-10 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since bioavailability can alter health risk estimates by a factor of 10, 100 or more, its importance in risk assessment cannot be underestimated. Presenting the basic principles that govern bioavailability and how it is measured, this very unique and timely book fills a void in the existing literature on toxicology and toxicokinetics. It contains clear and concise discussions on the behavior of environmental contaminants and how they reach the bloodstream in living organisms. It also presents an exhaustive review of measured bioavailability factors for environmental contaminants most frequently encountered at contaminated sites.
Download or read book Oral Bioavailability and Drug Delivery written by Ming Hu and published by John Wiley & Sons. This book was released on 2024-01-09 with total page 932 pages. Available in PDF, EPUB and Kindle. Book excerpt: ORAL BIOAVAILABILITY AND DRUG DELIVERY Improve the performance and viability of newly-developed and approved drugs with this crucial guide Bioavailability is the parameter which measures the rate and extent to which a drug reaches a user’s circulatory system depending on the method of administration. For example, intravenous administration produces a bioavailability of 100%, since the drugs are injected directly into the circulatory system; in the case of oral administration, however, bioavailability can vary widely based on factors which, if not properly understood, can result in a failure in drug development, adverse effects, and other complications. The mechanics of oral bioavailability are therefore critical aspects of drug development. Oral Bioavailability and Drug Delivery provides a comprehensive coverage of this subject as well as its drug development applications. Beginning with basic terminology and fundamental concepts, it provides a thorough understanding of the challenges and barriers to oral bioavailability as well as the possibilities for improving this parameter. The resulting book is an indispensable tool for drug development research. Oral Bioavailability and Drug Delivery readers will also find: Discussion questions in many chapters to facilitate comprehension Detailed discussion of topics including dissolution, absorption, metabolism, and more Real-world examples of methods in actions throughout Oral Bioavailability and Drug Delivery is ideal for pharmaceutical and biotechnology scientists working in drug discovery and development; researchers in chemistry, biology, pharmacology, immunology, neuroscience, and other related fields; and graduate courses in drug development and delivery.
Download or read book Bioavailability of Contaminants in Soils and Sediments written by National Research Council and published by National Academies Press. This book was released on 2003-05-03 with total page 433 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bioavailability refers to the extent to which humans and ecological receptors are exposed to contaminants in soil or sediment. The concept of bioavailability has recently piqued the interest of the hazardous waste industry as an important consideration in deciding how much waste to clean up. The rationale is that if contaminants in soil and sediment are not bioavailable, then more contaminant mass can be left in place without creating additional risk. A new NRC report notes that the potential for the consideration of bioavailability to influence decision-making is greatest where certain chemical, environmental, and regulatory factors align. The current use of bioavailability in risk assessment and hazardous waste cleanup regulations is demystified, and acceptable tools and models for bioavailability assessment are discussed and ranked according to seven criteria. Finally, the intimate link between bioavailability and bioremediation is explored. The report concludes with suggestions for moving bioavailability forward in the regulatory arena for both soil and sediment cleanup.
Download or read book Drug Bioavailability written by Han van de Waterbeemd and published by John Wiley & Sons. This book was released on 2006-03-06 with total page 602 pages. Available in PDF, EPUB and Kindle. Book excerpt: The peroral application (swallowing) of a medicine means that the body must first resorb the active substance before it can begin to take effect. The efficacy of drug uptake depends on the one hand on the chemical characteristics of the active substance, above all on its solubility and membrane permeability. On the other hand, it is determined by the organism's ability to absorb pharmaceuticals by way of specific transport proteins or to excrete them. Since many pharmacologically active substances are poorly suited for oral intake, a decisive criterion for the efficacy of a medicine is its so-called bioavailability. Written by an international team from academia and the pharmaceutical industry, this book covers all aspects of the oral bioavailability of medicines. The focus is placed on methods for determining the parameters relevant to bioavailability. These range from modern physicochemical techniques via biological studies in vitro and in vivo right up to computer-aided predictions. The authors specifically address possibilities for optimizing bioavailability during the early screening stage for the active substance. Its clear structure and comprehensive coverage make this book equally suitable for researchers and lecturers in industry and teaching.
Download or read book Topical Drug Bioavailability Bioequivalence and Penetration written by Vinod P. Shah and published by Springer. This book was released on 2015-01-30 with total page 393 pages. Available in PDF, EPUB and Kindle. Book excerpt: This authoritative volume explores advances in the techniques used to measure percutaneous penetration of drugs and chemicals to assess bioavailability and bioequivalence and discusses how they have been used in clinical and scientific investigations. Seven comprehensive sections examine topics including in vitro drug release, topical drugs products, clinical studies, and guidelines and workshop reports, among others. The book also describes how targeted transdermal drug delivery and more sophisticated mathematical modelling can aid in understanding the bioavailability of transdermal drugs. The first edition of this book was an important reference guide for researchers working to define the effectiveness and safety of drugs and chemicals that penetrated the skin. This second edition contains cutting-edge advances in the field and is a key resource to those seeking to define the bioavailability and bioequivalence of percutaneously active compounds to improve scientific and clinical investigation and regulation.
Download or read book Bioavailability of Organic Chemicals in Soil and Sediment written by Jose Julio Ortega-Calvo and published by Springer Nature. This book was released on 2020-10-15 with total page 428 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses bioavailability concepts and methods, summarizing the current knowledge on bioavailability science, as well as possible pathways for integrating bioavailability into risk assessment and the regulation of organic chemicals. Divided into 5 parts, it begins with an overview of chemical distribution in soil and sediment, as well as the bioavailability and bioaccumulation of chemicals in plants, soil, invertebrates and vertebrates (including humans). It then focuses on the impact of sorption processes and reviews bioavailability measurement methods. The closing chapters discuss the impact of bioavailability studies on chemical risk assessment, and highlights further research needs. Written by a multi-disciplinary team of authors, it is an essential resource for scientists in academia and industry, students, as well as for authorities.
Download or read book Oral Lipid Based Formulations written by David J. Hauss and published by CRC Press. This book was released on 2007-06-08 with total page 370 pages. Available in PDF, EPUB and Kindle. Book excerpt: Oral lipid-based formulations are attracting considerable attention due to their capacity to facilitate gastrointestinal absorption and reduce or eliminate the effect of food on the absorption of poorly water-soluble, lipophilic drugs. Despite the obvious and demonstrated utility of these formulations for addressing a persistent and growing problem
Download or read book Pharmaceutical Medicine written by Adrian Kilcoyne and published by OUP Oxford. This book was released on 2013-05-23 with total page 473 pages. Available in PDF, EPUB and Kindle. Book excerpt: The breadth of the pharmaceutical medicine can be daunting, but this book is designed to navigate a path through the speciality. Providing a broad overview of all topics relevant to the discipline of pharmaceutical medicine, it gives you the facts fast, in a user-friendly format, without having to dive through page upon page of dense text. With 136 chapters spread across 8 sections, the text offers a thorough grounding in issues ranging from medicines regulation to clinical trial design and data management. This makes it a useful revision aid for exams as well as giving you a taster of areas of pharmaceutical medicine adjacent to your current role. For healthcare professionals already working in the field, this book offers a guiding hand in difficult situations as well as supplying rapid access to the latest recommendations and guidelines. Written by authors with experience in the industry and drug regulation, this comprehensive and authoritative guide provides a shoulder to lean on throughout your pharmaceutical career.
Download or read book Oral Drug Delivery for Modified Release Formulations written by Edmund S. Kostewicz and published by John Wiley & Sons. This book was released on 2022-04-26 with total page 516 pages. Available in PDF, EPUB and Kindle. Book excerpt: ORAL DRUG DELIVERY FOR MODIFIED RELEASE FORMULATIONS Provides pharmaceutical development scientists with a detailed reference guide for the development of MR formulations Oral Drug Delivery for Modified Release Formulations is an up-to-date review of the key aspects of oral absorption from modified-release (MR) dosage forms. This edited volume provides in-depth coverage of the physiological factors that influence drug release and of the design and evaluation of MR formulations. Divided into three sections, the book begins by describing the gastrointestinal tract (GIT) and detailing the conditions and absorption processes occurring in the GIT that determine a formulation’s oral bioavailability. The second section explores the design of modified release formulations, covering early drug substance testing, the biopharmaceutics classification system, an array of formulation technologies that can be used for MR dosage forms, and more. The final section focuses on in vitro, in silico, and in vivo evaluation and regulatory considerations for MR formulations. Topics include biorelevant dissolution testing, preclinical evaluation, and physiologically-based pharmacokinetic modelling (PBPK) of in vivo behaviour. Featuring contributions from leading researchers with expertise in the different aspects of MR formulations, this volume: Provides authoritative coverage of physiology, physicochemical determinants, and in-vitro in-vivo correlation (IVIVC) Explains the different types of MR formulations and defines the key terms used in the field Discusses the present status of MR technologies and identifies current gaps in research Includes a summary of regulatory guidelines from both the US and the EU Shares industrial experiences and perspectives on the evaluation of MR dosage formulations Oral Drug Delivery for Modified Release Formulations is an invaluable reference and guide for researchers, industrial scientists, and graduate students in general areas of drug delivery including pharmaceutics, pharmaceutical sciences, biomedical engineering, polymer and materials science, and chemical and biochemical engineering.
