In Vitro Methods In Pharmaceutical Research


In Vitro Methods In Pharmaceutical Research
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In Vitro Methods In Pharmaceutical Research


In Vitro Methods In Pharmaceutical Research
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Author : Jose V. Castell
language : en
Publisher: Elsevier
Release Date : 1996-10-04

In Vitro Methods In Pharmaceutical Research written by Jose V. Castell and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 1996-10-04 with Medical categories.


In Vitro Methods in Pharmaceutical Research provides a comprehensive guide to laboratory techniques for evaluating in vitro organ toxicity using cellular models. Step-by-step practical tips on how to perform and interpret assays for drug metabolism and toxicity assessment are provided, along with a comparison of different techniques available. It is a welcome addition to the literature at a time when interest is growing in cellular in vitro models for toxicology and pharmacology studies. Meets the continuing demand for information in this field Compares In Vitro techniques with other methods Describes cell-culture methods used to investigate toxicity in cells derived from different organs Includes contributions by leading experts in the field



In Vitro And In Vivo Tools In Drug Delivery Research For Optimum Clinical Outcomes


In Vitro And In Vivo Tools In Drug Delivery Research For Optimum Clinical Outcomes
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Author : Ambikanandan Misra
language : en
Publisher: CRC Press
Release Date : 2018-06-22

In Vitro And In Vivo Tools In Drug Delivery Research For Optimum Clinical Outcomes written by Ambikanandan Misra and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-06-22 with Medical categories.


This book covers the essentials of drug delivery research and provides a unique forum for scientific experimental methods that are exclusively focused by the in-vitro, ex-vivo, and in-vivo methodologies of drug delivery research and felicitates translational research. The book includes recent and novel approaches in evaluation methods of transdermal, nasal, ocular, oral and intraoral, gastro-retentive, colon-targeted, and brain-targeted drug delivery systems. Providing up to date and comprehensive information, this text is invaluable to students, teachers, scientists, and others employed in the field of drug delivery.



Optimization In Drug Discovery


Optimization In Drug Discovery
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Author : Gary W. Caldwell
language : en
Publisher: Humana
Release Date : 2016-08-23

Optimization In Drug Discovery written by Gary W. Caldwell and has been published by Humana this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-08-23 with Medical categories.


Thoroughly revised and updated, Optimization in Drug Discovery: In Vitro Methods, Second Edition presents a wide spectrum of in vitro assays including formulation, plasma binding, absorption and permeability, cytochrome P450 (CYP) and UDP-glucuronosyltransferases (UGT) metabolism, CYP inhibition and induction, drug transporters, drug-drug interactions via assessment of reactive metabolites, genotoxicity, and chemical and photo-mutagenicity assays. Written for the Methods in Pharmacology and Toxicology series, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible protocols, and tips on troubleshooting and avoiding known pitfalls. Expert authors have developed and utilized these in vitro assays to achieve “drug-like” characteristics in addition to efficacy properties and good safety profiles of drug candidates. Comprehensive and up-to-date, Optimization in Drug Discovery: In Vitro Methods, Second Edition aims to guide researchers down the difficult path to successful drug discovery and development.



Pharmaceutical Product Development


Pharmaceutical Product Development
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Author : Chilukuri Dakshina Murthy
language : en
Publisher: CRC Press
Release Date : 2007-02-12

Pharmaceutical Product Development written by Chilukuri Dakshina Murthy and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-02-12 with Medical categories.


During the last two decades, the pharmaceutical industry has been under pressure to reduce development costs and the time needed to bring drugs to market in order to maximize return on investment and bring treatments to patients sooner. To meet these ends, pharmaceutical scientists working in the differing areas of pharmacy, pharmaceutics, and phar



Bayesian Methods In Pharmaceutical Research


Bayesian Methods In Pharmaceutical Research
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Author : Emmanuel Lesaffre
language : en
Publisher: CRC Press
Release Date : 2020-04-15

Bayesian Methods In Pharmaceutical Research written by Emmanuel Lesaffre and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-04-15 with Medical categories.


Since the early 2000s, there has been increasing interest within the pharmaceutical industry in the application of Bayesian methods at various stages of the research, development, manufacturing, and health economic evaluation of new health care interventions. In 2010, the first Applied Bayesian Biostatistics conference was held, with the primary objective to stimulate the practical implementation of Bayesian statistics, and to promote the added-value for accelerating the discovery and the delivery of new cures to patients. This book is a synthesis of the conferences and debates, providing an overview of Bayesian methods applied to nearly all stages of research and development, from early discovery to portfolio management. It highlights the value associated with sharing a vision with the regulatory authorities, academia, and pharmaceutical industry, with a view to setting up a common strategy for the appropriate use of Bayesian statistics for the benefit of patients. The book covers: Theory, methods, applications, and computing Bayesian biostatistics for clinical innovative designs Adding value with Real World Evidence Opportunities for rare, orphan diseases, and pediatric development Applied Bayesian biostatistics in manufacturing Decision making and Portfolio management Regulatory perspective and public health policies Statisticians and data scientists involved in the research, development, and approval of new cures will be inspired by the possible applications of Bayesian methods covered in the book. The methods, applications, and computational guidance will enable the reader to apply Bayesian methods in their own pharmaceutical research.



Drug Absorption Studies


Drug Absorption Studies
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Author : Carsten Ehrhardt
language : en
Publisher: Springer Science & Business Media
Release Date : 2007-12-22

Drug Absorption Studies written by Carsten Ehrhardt and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-12-22 with Medical categories.


This is a well thought-out, highly practical text covering contemporary ‘in vitro’ techniques for drug absorption studies. Starting at the molecular level of investigation, it continues with cell monolayer models (both primary and cell lines) and culminates with in situ techniques as a final testing format. In addition, chapters on high-throughput assays, in vitro-in vivo correlation, bioinformatics and regulatory issues are covered, giving a comprehensive overview of available models and techniques. Moreover, an appendix consisting of a number of practical protocols is available online, updated as needed, and should prove very helpful to apply the techniques directly to the benchside.



Monoclonal Antibody Production


Monoclonal Antibody Production
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Author : National Research Council
language : en
Publisher: National Academies Press
Release Date : 1999-05-06

Monoclonal Antibody Production written by National Research Council and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1999-05-06 with Medical categories.


The American Anti-Vivisection Society (AAVS) petitioned the National Institutes of Health (NIH) on April 23, 1997, to prohibit the use of animals in the production of mAb. On September 18, 1997, NIH declined to prohibit the use of mice in mAb production, stating that "the ascites method of mAb production is scientifically appropriate for some research projects and cannot be replaced." On March 26, 1998, AAVS submitted a second petition, stating that "NIH failed to provide valid scientific reasons for not supporting a proposed ban." The office of the NIH director asked the National Research Council to conduct a study of methods of producing mAb. In response to that request, the Research Council appointed the Committee on Methods of Producing Monoclonal Antibodies, to act on behalf of the Institute for Laboratory Animal Research of the Commission on Life Sciences, to conduct the study. The 11 expert members of the committee had extensive experience in biomedical research, laboratory animal medicine, animal welfare, pain research, and patient advocacy (Appendix B). The committee was asked to determine whether there was a scientific necessity for the mouse ascites method; if so, whether the method caused pain or distress; and, if so, what could be done to minimize the pain or distress. The committee was also asked to comment on available in vitro methods; to suggest what acceptable scientific rationale, if any, there was for using the mouse ascites method; and to identify regulatory requirements for the continued use of the mouse ascites method. The committee held an open data-gathering meeting during which its members summarized data bearing on those questions. A 1-day workshop (Appendix A) was attended by 34 participants, 14 of whom made formal presentations. A second meeting was held to finalize the report. The present report was written on the basis of information in the literature and information presented at the meeting and the workshop.



In Vitro Bioassay Techniques For Anticancer Drug Discovery And Development


In Vitro Bioassay Techniques For Anticancer Drug Discovery And Development
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Author : Dhanya Sunil
language : en
Publisher: CRC Press
Release Date : 2017-05-18

In Vitro Bioassay Techniques For Anticancer Drug Discovery And Development written by Dhanya Sunil and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-05-18 with Medical categories.


This comprehensive and useful handbook represents a definitive up-to-date compendium of key in vitro bioassay methods that are employed to quantify and validate the anticancer activity of a drug candidate before it makes its way in to animal or clinical trials. In Vitro Bioassay Techniques for Anticancer Drug Discovery and Development covers the screening and evaluation of potential drug candidates in a wide category of anticancer assays demonstrating the specific ways in which various pharmaceutical bioassays interpret the activity of drug molecules. The major emphasis of the book is to present those bioassays which can be readily set up and practiced in any laboratory with limited funds, facilities or technical know-how.



In Vitro Drug Release Testing Of Special Dosage Forms


In Vitro Drug Release Testing Of Special Dosage Forms
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Author : Nikoletta Fotaki
language : en
Publisher: John Wiley & Sons
Release Date : 2019-10-11

In Vitro Drug Release Testing Of Special Dosage Forms written by Nikoletta Fotaki and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-10-11 with Science categories.


Guides readers on the proper use of in vitro drug release methodologies in order to evaluate the performance of special dosage forms In the last decade, the application of drug release testing has widened to a variety of novel/special dosage forms. In order to predict the in vivo behavior of such dosage forms, the design and development of the in vitro test methods need to take into account various aspects, including the dosage form design and the conditions at the site of application and the site of drug release. This unique book is the first to cover the field of in vitro release testing of special dosage forms in one volume. Featuring contributions from an international team of experts, it presents the state of the art of the use of in vitro drug release methodologies for assessing special dosage forms’ performances and describes the different techniques required for each one. In Vitro Drug Release Testing of Special Dosage Forms covers the in vitro release testing of: lipid based oral formulations; chewable oral drug products; injectables; drug eluting stents; inhalation products; transdermal formulations; topical formulations; vaginal and rectal delivery systems and ophthalmics. The book concludes with a look at regulatory aspects. Covers both oral and non-oral dosage forms Describes current regulatory conditions for in vitro drug release testing Features contributions from well respected global experts in dissolution testing In Vitro Drug Release Testing of Special Dosage Forms will find a place on the bookshelves of anyone working with special dosage forms, dissolution testing, drug formulation and delivery, pharmaceutics, and regulatory affairs.



Drug Discovery And Evaluation Methods In Clinical Pharmacology


Drug Discovery And Evaluation Methods In Clinical Pharmacology
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Author : H.Gerhard Vogel
language : en
Publisher: Springer Science & Business Media
Release Date : 2010-12-15

Drug Discovery And Evaluation Methods In Clinical Pharmacology written by H.Gerhard Vogel and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-12-15 with Medical categories.


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".