Analysis Of Investigational Drugs In Biological Fluids Method Development And Routine Assay

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Analysis of Investigational Drugs in Biological Fluids Method Development and Routine Assay

Author : Emil T. Lin
Publisher :
ISBN 13 :
Total Pages : 175 pages
Book Rating : 4.:/5 (227 download)

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Download or read book Analysis of Investigational Drugs in Biological Fluids Method Development and Routine Assay written by Emil T. Lin and published by . This book was released on 1992 with total page 175 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report describes technical work accomplished and information gained in performance of contract number DAMDl786-C-6150, entitled Analysis of Investigational Drugs in Biological Fluids - Method Development and Routine Assay, for the US Army Medical Research and Development Command (USAMRDC). We were able to complete ten projects for determination of test article concentrations in terms of method development, validation, and characterization. We demonstrated sensitivity, specificity, linearity, lack of interferences, accuracy, and reproducibility of the analytical method, described the extent of recovery for the method, and reported on the stability of compounds of interest in specimens during storage and drug analysis. Methods developed were such that a single technician could complete at least 15 clinical samples in one day. These methods were robust and portable enough to be transported to other laboratories. Six projects on ten compounds were begun during the contract period, one of which was cancelled, and the remaining five have reached various stages of completeness at the end of the contract period. Routine analyses of samples were performed for 33 studies (or pilot studies) designated by WRAIR. The breakdown of routine analyses studies by compound(s) follows: Halofantrine and/or WR 178,460,8 studies; Mefloquine 3 studies, Physostigmine and/or Eseroline, 6 studies; Pyridostigmine, 10 studies; WR 238605,3 studies; and WR 6026 and/or WR 211789,3 studies. Final, Method, Development, Routine Assay.

Analysis of Investigational Drugs in Biological Fluids. Method Development and Routine Assay. Appendix B.

Author :
Publisher :
ISBN 13 :
Total Pages : 100 pages
Book Rating : 4.:/5 (227 download)

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Download or read book Analysis of Investigational Drugs in Biological Fluids. Method Development and Routine Assay. Appendix B. written by and published by . This book was released on 1997 with total page 100 pages. Available in PDF, EPUB and Kindle. Book excerpt: Using the procedures described in this report, we were able to work sequentially or simultaneously on eleven projects: (1) WR 238,605, (2) halofantrine (and its metabolite), (3) WR 6026 (and its metabolites), (4) mefloquine (and its metabolite), (5) artelinic acid, (6) p-aminoheptanophenone (and related compounds), (7) primaquine (and its metabolite), (8) gentamicin and paromomycin, (9) pyridostigmine, (10) chloroquine (and its metabolites), and (11) a multiple drug interaction study in dog plasma for WR 238,605, mefloquine, chloroquine, quinine, doxycycline, and halofantrine with additional work on development and validation of LC/MS/MS methods for halofantrine (and its metabolite), WR 238,605) in terms of method development, validation, and characterization. We worked on demonstrating sensitivity, specificity, linearity, lack of interferences, accuracy, and reproducibility of the analytical method, describing the extent of recovery for the method, and reporting on the stability of compounds of interest in specimens during storage and drug analysis to provide documentation in support of Investigational New Drug (IND) submissions to the Food and Drug Administration (FDA).

Analysis of Investigational Drugs in Biological Fluids. Method Development and Routine Assay. Appendix A.

Author :
Publisher :
ISBN 13 :
Total Pages : 274 pages
Book Rating : 4.:/5 (227 download)

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Download or read book Analysis of Investigational Drugs in Biological Fluids. Method Development and Routine Assay. Appendix A. written by and published by . This book was released on 1997 with total page 274 pages. Available in PDF, EPUB and Kindle. Book excerpt: Using the procedures described in this report, we were able to work sequentially or simultaneously on eleven projects: (1) WR 238,605, (2) halofantrine (and its metabolite), (3) WR 6026 (and its metabolites), (4) mefloquine (and its metabolite), (5) artelinic acid, (6) p-aminoheptanophenone (and related compounds), (7) primaquine (and its metabolite), (8) gentamicin and paromomycin, (9) pyridostigmine, (10) chloroquine (and its metabolites), and (11) a multiple drug interaction study in dog plasma for WR 238,605, mefloquine, chloroquine, quinine, doxycycline, and halofantrine with additional work on development and validation of LC/MS/MS methods for halofantrine (and its metabolite), WR 238,605) in terms of method development, validation, and characterization. We worked on demonstrating sensitivity, specificity, linearity, lack of interferences, accuracy, and reproducibility of the analytical method, describing the extent of recovery for the method, and reporting on the stability of compounds of interest in specimens during storage and drug analysis to provide documentation in support of Investigational New Drug (IND) submissions to the Food and Drug Administration (FDA).

Analysis of Investigational Drugs in Biological Fluids - Method Development and Analysis of Pre-Clinical and Clinical Samples

Author :
Publisher :
ISBN 13 :
Total Pages : 148 pages
Book Rating : 4.:/5 (946 download)

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Download or read book Analysis of Investigational Drugs in Biological Fluids - Method Development and Analysis of Pre-Clinical and Clinical Samples written by and published by . This book was released on 1999 with total page 148 pages. Available in PDF, EPUB and Kindle. Book excerpt: Using the procedures described in this report, we were able to work sequentially or simultaneously on development, validation and characterization of assays for WR 6026 (and its metabolites, WR 211789 and WR 254421), mefloquine (and its metabolite, WR 160972), p-aminoheptanophenone (and related compounds), WR 242511, halofantrine (and its metabolite, WR 178,460, and their stereoisomers), chloroquine (and its metabolites, monodesethylchloroquine and didesethylchloroquine), WR 243,251, WR 238,605, doxycycline, gentamicin, paromomycin and artelinic add. Work on routine analyses of biological specimens during this period was performed for studies that required determination of concentrations of artelinic acid, gentamicin and paromomycin. We worked on demonstrating sensitivity, specificity, linearity, lack of interferences, accuracy, and reproducibility of the analytical method, describing the extent of recovery for the method, and reporting on the stability of compounds of interest in specimens during storage and drug analysis to provide documentation in support of Investigational New Drug (IND) submissions to the Food and Drug Administration (FDA).

Analysis of Investigational Drugs in Biological Fluids-Method Development

Author :
Publisher :
ISBN 13 :
Total Pages : 219 pages
Book Rating : 4.:/5 (455 download)

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Download or read book Analysis of Investigational Drugs in Biological Fluids-Method Development written by and published by . This book was released on 1998 with total page 219 pages. Available in PDF, EPUB and Kindle. Book excerpt: Using the procedures described in this report, we were able to work sequentially or simultaneously on development, validation and characterization of assays for WR 238,605 (and its stereoisomers), halofantrine (and its metabolite and their stereoisomers), WR 6026 (and its metabolites), mefloquine (and its metabolite), artelinic acid, p-aminoheptanophenone (and related compounds), gentamicin and paromomycin, pyridostigmine, WR 242511, chloroquine (and its metabolites), WR 243,251, quinine and doxycycline. Work on routine analyses of biological specimens during this period was performed for studies that required determination of concentrations of WR 238,605 (and its stereoisomers), halofantrine (and its metabolite and their stereoisomers), WR 6026 (and its metabolites), mefloquine, p-aminoheptanophenone (and related compounds), primaquine, gentamicin and paromomycin, chloroquine (and its metabolites), quinine, and doxycycline. We worked on demonstrating sensitivity, specificity, linearity, lack of interferences, accuracy, and reproducibility of the analytical method, describing the extent of recovery for the method, and reporting on the stability of compounds of interest in specimens during storage and drug analysis to provide documentation in support of Investigational New Drug (IND) submissions to the Food and Drug Administration (FDA).

Analysis of Investigational Drugs in Biological Fluids - Method Development and Analysis of Pre-Clinical Samples

Author :
Publisher :
ISBN 13 :
Total Pages : 127 pages
Book Rating : 4.:/5 (946 download)

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Download or read book Analysis of Investigational Drugs in Biological Fluids - Method Development and Analysis of Pre-Clinical Samples written by and published by . This book was released on 2001 with total page 127 pages. Available in PDF, EPUB and Kindle. Book excerpt: Work on development and/or validation of analytical methodologies during the current contract focused on assays for WR 6026 (and its metabolites, WR 211789 and WR 254421), mefloquine (and its metabolite, WR 160972), p-aminoheptanophenone (and related compounds), WR 242511, halofantrine (and its metabolite, WR 178,460, and their stereoisomers), chloroquine (and its metabolites, monodesethylchoroquine and didesethyichloroquine), WR 243,251, WR 238,605, gentamicin, paromomycin and artelinic acid (and metabolites and artesunate). Work on routine analyses of biological specimens during this period was performed for studies that required determination of concentrations of artelinic acid, choroquine (and its metabolites, monodesethyichloroquine and didesethylchloroquine), and stereoisomers of halofantrine (and its metabolite, WR 178,460).

The Analysis of Drugs in Biological Fluids

Author : Joseph Chamberlain
Publisher : CRC Press
ISBN 13 : 1351411438
Total Pages : 366 pages
Book Rating : 4.3/5 (514 download)

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Download or read book The Analysis of Drugs in Biological Fluids written by Joseph Chamberlain and published by CRC Press. This book was released on 2018-02-06 with total page 366 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new edition focuses on a variety of techniques available for the analysis of drugs in biological fluids. Over 150 figures and tables help to describe the latest advances and give examples of their applications. Current chiral analysis methods as well as discussions on the impact of chirality are described. Practical aspects of bioanalytical work, including many examples of laboratory problems not often reported in the scientific literature, are examined in depth.

Guideline for Submitting Samples and Analytical Data for Methods Validation

Author :
Publisher :
ISBN 13 :
Total Pages : 28 pages
Book Rating : 4.3/5 (91 download)

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Download or read book Guideline for Submitting Samples and Analytical Data for Methods Validation written by and published by . This book was released on 1987 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Catalog of Federal Domestic Assistance

Author :
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ISBN 13 :
Total Pages : 1100 pages
Book Rating : 4.:/5 (8 download)

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Download or read book Catalog of Federal Domestic Assistance written by and published by . This book was released on 2008 with total page 1100 pages. Available in PDF, EPUB and Kindle. Book excerpt: Identifies and describes specific government assistance opportunities such as loans, grants, counseling, and procurement contracts available under many agencies and programs.

Technical Reports Awareness Circular : TRAC.

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ISBN 13 :
Total Pages : 520 pages
Book Rating : 4.E/5 ( download)

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Download or read book Technical Reports Awareness Circular : TRAC. written by and published by . This book was released on 1987 with total page 520 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Directory of Biomedical and Health Care Grants 2004

Author : Oryx Press
Publisher : Greenwood
ISBN 13 : 9781573565943
Total Pages : 540 pages
Book Rating : 4.5/5 (659 download)

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Book Synopsis Directory of Biomedical and Health Care Grants 2004 by : Oryx Press

Download or read book Directory of Biomedical and Health Care Grants 2004 written by Oryx Press and published by Greenwood. This book was released on 2005 with total page 540 pages. Available in PDF, EPUB and Kindle. Book excerpt: This latest edition covers over 2,300 funding sources from all levels of government, corporations, and foundations.

Government Reports Announcements & Index

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ISBN 13 :
Total Pages : 852 pages
Book Rating : 4.:/5 (3 download)

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Download or read book Government Reports Announcements & Index written by and published by . This book was released on 1992-10 with total page 852 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Modern Methods of Clinical Investigation

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309042860
Total Pages : 241 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Modern Methods of Clinical Investigation by : Institute of Medicine

Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

Notices of Changes in Classification, Distribution and Availability

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ISBN 13 :
Total Pages : 694 pages
Book Rating : 4.E/5 ( download)

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Download or read book Notices of Changes in Classification, Distribution and Availability written by and published by . This book was released on 1998-04 with total page 694 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Fools, Knaves and Heroes

Author : Jeffrey Archer
Publisher : DIANE Publishing
ISBN 13 : 0788173928
Total Pages : 1694 pages
Book Rating : 4.7/5 (881 download)

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Book Synopsis Fools, Knaves and Heroes by : Jeffrey Archer

Download or read book Fools, Knaves and Heroes written by Jeffrey Archer and published by DIANE Publishing. This book was released on 1998-07 with total page 1694 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Government Reports Annual Index

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ISBN 13 :
Total Pages : 1192 pages
Book Rating : 4.:/5 (89 download)

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Download or read book Government Reports Annual Index written by and published by . This book was released on 1991 with total page 1192 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Tietz Textbook of Clinical Chemistry and Molecular Diagnostics

Author : Nader Rifai
Publisher : Elsevier Health Sciences
ISBN 13 : 0323548482
Total Pages : 1888 pages
Book Rating : 4.3/5 (235 download)

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Book Synopsis Tietz Textbook of Clinical Chemistry and Molecular Diagnostics by : Nader Rifai

Download or read book Tietz Textbook of Clinical Chemistry and Molecular Diagnostics written by Nader Rifai and published by Elsevier Health Sciences. This book was released on 2017-01-16 with total page 1888 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 6th Edition provides the most current and authoritative guidance on selecting, performing, and evaluating the results of new and established laboratory tests. This classic clinical chemistry reference offers encyclopedic coverage detailing everything you need to know, including: analytical criteria for the medical usefulness of laboratory tests, variables that affect tests and results, laboratory medicine, applications of statistical methods, and most importantly clinical utility and interpretation of laboratory tests. It is THE definitive reference in clinical chemistry and molecular diagnostics, now fully searchable and with quarterly content updates, podcasts, clinical cases, animations, and extended content online through Expert Consult. Analytical criteria focus on the medical usefulness of laboratory procedures. Reference ranges show new approaches for establishing these ranges — and provide the latest information on this topic. Lab management and costs gives students and chemists the practical information they need to assess costs, allowing them to do their job more efficiently and effectively. Statistical methods coverage provides you with information critical to the practice of clinical chemistry. Internationally recognized chapter authors are considered among the best in their field. Two-color design highlights important features, illustrations, and content to help you find information easier and faster. NEW! Internationally recognized chapter authors are considered among the best in their field. NEW! Expert Consult features fully searchable text, quarterly content updates, clinical case studies, animations, podcasts, atlases, biochemical calculations, multiple-choice questions, links to Medline, an image collection, and audio interviews. You will now enjoy an online version making utility of this book even greater. UPDATED! Expanded Molecular Diagnostics section with 12 chapters that focus on emerging issues and techniques in the rapidly evolving and important field of molecular diagnostics and genetics ensures this text is on the cutting edge and of the most value. NEW! Comprehensive list of Reference Intervals for children and adults with graphic displays developed using contemporary instrumentation. NEW! Standard and international units of measure make this text appropriate for any user — anywhere in the world. NEW! 22 new chapters that focus on applications of mass spectrometry, hematology, transfusion medicine, microbiology, biobanking, biomarker utility in the pharmaceutical industry and more! NEW! Expert senior editors, Nader Rifai, Carl Wittwer and Rita Horvath, bring fresh perspectives and help ensure the most current information is presented. UPDATED! Thoroughly revised and peer-reviewed chapters provide you with the most current information possible.