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Author: Ramakrishna Seethala
Publisher: CRC Press
ISBN: 0824741447
Category : Medical
Languages : en
Pages : 619
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Book Description
A presentation of screening techniques, modern technologies, and high-capacity instrumentation for increased productivity in the development and discovery of new drugs, chemical compounds, and targeted delivery of pharmaceuticals. It contains practical applications and examples of strategies in cell-based and cell-free screens as well as homogeneous, fluorescence, chemiluminescence, and radioactive-based technologies.
Author: Ramakrishna Seethala
Publisher: CRC Press
ISBN: 0824741447
Category : Medical
Languages : en
Pages : 619
Get Book Here
Book Description
A presentation of screening techniques, modern technologies, and high-capacity instrumentation for increased productivity in the development and discovery of new drugs, chemical compounds, and targeted delivery of pharmaceuticals. It contains practical applications and examples of strategies in cell-based and cell-free screens as well as homogeneous, fluorescence, chemiluminescence, and radioactive-based technologies.
Author: Ramakrishna Seethala
Publisher: CRC Press
ISBN: 1420061690
Category : Medical
Languages : en
Pages : 506
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Book Description
Building upon the foundation of basics discussed in the previous edition, the Second Edition provides a more in-depth look at the latest methods and technologies of advanced drug screening, an essential function of drug discovery. With extensively updated content and 21 new chapters, this text examines:quality and efficiency of drug target validati
Author: Ramakrishna Seethala
Publisher: CRC Press
ISBN:
Category : Medical
Languages : en
Pages : 512
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Book Description
A presentation of screening techniques, modern technologies, and high-capacity instrumentation for increased productivity in the development and discovery of new drugs, chemical compounds, and targeted delivery of pharmaceuticals. It contains practical applications and examples of strategies in cell-based and cell-free screens as well as homogeneous, fluorescence, chemiluminescence, and radioactive-based technologies.
Author: Sarfaraz K. Niazi
Publisher: CRC Press
ISBN: 9780849303951
Category : Medical
Languages : en
Pages : 0
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Book Description
As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more difficult to conduct and summarize. The Handbook of Bioequivalence Testing offers a complete description of every aspect of bioequivalence testing. Features: Describes the current analytical methods used in bioequivalence testing, as well as their respective strengths and limitations Discusses worldwide regulatory requirements for filing for approval of generic drugs Covers GLP, GCP, and 21 CFR compliance requirements for qualifying studies for regulatory submission and facility certification Includes actual examples of reports approved by regulatory authorities to illustrate various scientific, regulatory, and formatting aspects Provides a list of vendors for the software used to analyze bioequivalence studies and recommendations Explains how to apply for a waiver, how to secure regulatory approval of reports, and how to obtain regulatory certification of facilities conducting bioequivalence studies
Author: Joseph I. Boullata
Publisher: Springer Science & Business Media
ISBN: 160327362X
Category : Science
Languages : en
Pages : 823
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Book Description
Handbook of Drug-Nutrient Interactions, Second Edition is an essential new work that provides a scientific look behind many drug-nutrient interactions, examines their relevance, offers recommendations, and suggests research questions to be explored. In the five years since publication of the first edition of the Handbook of Drug-Nutrient Interactions new perspectives have emerged and new data have been generated on the subject matter. Providing both the scientific basis and clinical relevance with appropriate recommendations for many interactions, the topic of drug-nutrient interactions is significant for clinicians and researchers alike. For clinicians in particular, the book offers a guide for understanding, identifying or predicting, and ultimately preventing or managing drug-nutrient interactions to optimize patient care. Divided into six sections all chapters have been revised or are new to this edition. Chapters balance the most technical information with practical discussions and include outlines that reflect the content; discussion questions that can guide the reader to the critical areas covered in each chapter, complete definitions of terms with the abbreviation fully defined and consistent use of terms between chapters. The editors have performed an outstanding service to clinical pharmacology and pharmaco-nutrition by bringing together a multi-disciplinary group of authors. Handbook of Drug-Nutrient Interactions, Second Edition is a comprehensive up-to-date text for the total management of patients on drug and/or nutrition therapy but also an insight into the recent developments in drug-nutrition interactions which will act as a reliable reference for clinicians and students for many years to come.
Author: Ali S. Faqi
Publisher: Academic Press
ISBN: 0128036214
Category : Medical
Languages : en
Pages : 988
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Book Description
A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Second Edition, is a valuable reference designed to provide a complete understanding of all aspects of nonclinical toxicology in the development of small molecules and biologics. This updated edition has been reorganized and expanded to include important topics such as stem cells in nonclinical toxicology, inhalation and dermal toxicology, pitfalls in drug development, biomarkers in toxicology, and more. Thoroughly updated to reflect the latest scientific advances and with increased coverage of international regulatory guidelines, this second edition is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. - Provides unique content that is not always covered together in one comprehensive resource, including chapters on stem cells, abuse liability, biomarkers, inhalation toxicology, biostatistics, and more - Updated with the latest international guidelines for nonclinical toxicology in both small and large molecules - Incorporates practical examples in order to illustrate day-to-day activities and the expectations associated with working in nonclinical toxicology
Author: Beverly A. Teicher
Publisher: Springer Science & Business Media
ISBN: 1592597394
Category : Medical
Languages : en
Pages : 514
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Book Description
This unique volume traces the critically important pathway by which a "molecule" becomes an "anticancer agent. " The recognition following World War I that the administration of toxic chemicals such as nitrogen mustards in a controlled manner could shrink malignant tumor masses for relatively substantial periods of time gave great impetus to the search for molecules that would be lethal to specific cancer cells. Weare still actively engaged in that search today. The question is how to discover these "anticancer" molecules. Anticancer Drug Development Guide: Preclinical Screening, Clinical Trials, and Approval, Second Edition describes the evolution to the present of preclinical screening methods. The National Cancer Institute's high-throughput, in vitro disease-specific screen with 60 or more human tumor cell lines is used to search for molecules with novel mechanisms of action or activity against specific phenotypes. The Human Tumor Colony-Forming Assay (HTCA) uses fresh tumor biopsies as sources of cells that more nearly resemble the human disease. There is no doubt that the greatest successes of traditional chemotherapy have been in the leukemias and lymphomas. Since the earliest widely used in vivo drug screening models were the murine L 1210 and P388 leukemias, the community came to assume that these murine tumor models were appropriate to the discovery of "antileukemia" agents, but that other tumor models would be needed to discover drugs active against solid tumors.
Author: Sarfaraz K. Niazi
Publisher: CRC Press
ISBN: 1482226375
Category : Medical
Languages : en
Pages : 1012
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Book Description
As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more complex. The second edition of Handbook of Bioequivalence Testing has been completely updated to include the most current information available, including new findings in drug delivery and dosage form design and revised worldwide regulatory requirements. New topics include: A historical perspective on generic pharmaceuticals New guidelines governing submissions related to bioequivalency studies, along with therapeutic code classifications Models of noninferiority Biosimilarity of large molecule drugs Bioequivalence of complementary and alternate medicines Bioequivalence of biosimilar therapeutic proteins and monoclonal antibodies New FDA guidelines for bioanalytical method validation Outsourcing and monitoring of bioequivalence studies The cost of generic drugs is rising much faster than in the past, partly because of the increased costs required for approval—including those for bioequivalence testing. There is a dire need to re-examine the science behind this type of testing to reduce the burden of development costs—allowing companies to develop generic drugs faster and at a lower expense. The final chapter explores the future of bioequivalence testing and proposes radical changes in the process of biowaivers. It suggests how the cost of demonstrating bioequivalence can be reduced through intensive analytical investigation and proposes that regulatory agencies reduce the need for bioequivalence studies in humans. Backed by science and updated with the latest research, this book is destined to spark continued debate on the efficacy of the current bioequivalence testing paradigm.
Author: Pascal Kintz
Publisher: CRC Press
ISBN: 1420006193
Category : Law
Languages : en
Pages : 396
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Book Description
Many advances have been made since the publication of Drug Testing in Hair. The mid-1990s witnessed the progress in cannabis detection while the late 1990s focused on benzodiazepines detection and the applications in doping control. In more recent years, toxicologists centered on the detection in hair of a single exposure and the related applicatio
Author: Michael R. Bleavins
Publisher: John Wiley & Sons
ISBN: 1118210425
Category : Medical
Languages : en
Pages : 559
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Book Description
Discover how biomarkers can boost the success rate of drug development efforts As pharmaceutical companies struggle to improve the success rate and cost-effectiveness of the drug development process, biomarkers have emerged as a valuable tool. This book synthesizes and reviews the latest efforts to identify, develop, and integrate biomarkers as a key strategy in translational medicine and the drug development process. Filled with case studies, the book demonstrates how biomarkers can improve drug development timelines, lower costs, facilitate better compound selection, reduce late-stage attrition, and open the door to personalized medicine. Biomarkers in Drug Development is divided into eight parts: Part One offers an overview of biomarkers and their role in drug development. Part Two highlights important technologies to help researchers identify new biomarkers. Part Three examines the characterization and validation process for both drugs and diagnostics, and provides practical advice on appropriate statistical methods to ensure that biomarkers fulfill their intended purpose. Parts Four through Six examine the application of biomarkers in discovery, preclinical safety assessment, clinical trials, and translational medicine. Part Seven focuses on lessons learned and the practical aspects of implementing biomarkers in drug development programs. Part Eight explores future trends and issues, including data integration, personalized medicine, and ethical concerns. Each of the thirty-eight chapters was contributed by one or more leading experts, including scientists from biotechnology and pharmaceutical firms, academia, and the U.S. Food and Drug Administration. Their contributions offer pharmaceutical and clinical researchers the most up-to-date understanding of the strategies used for and applications of biomarkers in drug development.
