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.
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).
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).
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).
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).
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).
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.
Download or read book New Drug Development written by J. Rick Turner and published by John Wiley & Sons. This book was released on 2007-07-27 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book acquaints students and practitioners in the related fields of pharmaceutical sciences, clinical trials, and evidence-based medicine with the necessary study design concepts and statistical practices to allow them to understand how drug developers plan and evaluate their drug development. Two goals of the book are to make the material accessible to readers with minimal background in research and to be straightforward enough for self-taught purposes. By bringing the topic from the early discovery phase to clinical trials and medical practice, the book provides an indispensable overview of an otherwise confusing and fragmented set of topics. The author’s experience as a respected scientist, teacher of statistics, and one who has worked in the clinical trials arena makes him well suited to write such a treatise.
Download or read book Assay of Drugs and Other Trace Compounds in Biological Fluids written by Eric Reid and published by North-Holland. This book was released on 1976 with total page 274 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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:
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:
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.
Download or read book Development of Analytical Methods for the Determination of Drug Substances in Biological Fluids written by Emil T. Lin and published by . This book was released on 1985 with total page 35 pages. Available in PDF, EPUB and Kindle. Book excerpt: Methods available to quantitate halofantrine, an antimalarial drug with demonstrated activity against Plasmodium falciparum, in blood and plasma are limited. We report the development of a simple and rapid HPLC assay for the analysis of 0.5 ml blood and plasma specimens. The method detection limit is 1 ng/ml for both halofantrine (WR 171,669) and its putative metabolite (WR 178,460). The method's principal techniques include sample cleanup by protein precipitation and by a column elution step, precautions against loss of drug because of absorption to glass, and fluorescence detection. The method proved adequate in tests of linearity, recovery, precision, and accuracy. Drug stability tests of specimens stored at -20C and 80C indicated the necessity of storage at 80C. Routine analysis of human and animal blood plasma samples were satisfactory performed. Keywords: Halofantrine (WR 171,669), Putative Metabolite (WR 178,460); Blood; Blood Plasma.
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:
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:
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:
Download or read book Tietz Textbook of Clinical Chemistry and Molecular Diagnostics E Book written by Nader Rifai and published by Elsevier Health Sciences. This book was released on 2017-01-16 with total page 4785 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.
