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 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 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 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 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 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 The Prevention and Treatment of Missing Data in Clinical Trials written by National Research Council and published by National Academies Press. This book was released on 2010-12-21 with total page 163 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Download or read book Improving and Accelerating Therapeutic Development for Nervous System Disorders written by Institute of Medicine and published by National Academies Press. This book was released on 2014-02-06 with total page 107 pages. Available in PDF, EPUB and Kindle. Book excerpt: Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.
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.
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 Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.
Download or read book A Practical Guide to Managing Clinical Trials written by JoAnn Pfeiffer and published by CRC Press. This book was released on 2017-05-18 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.
Download or read book Using Mass Spectrometry for Drug Metabolism Studies written by Walter A. Korfmacher and published by CRC Press. This book was released on 2004-12-17 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: Mass spectrometry (MS) is fast becoming the premier tool for analyzing various drug metabolism samples in the early phases of drug discovery and research. Introducing the newer, more powerful MS equipment and exploring new applications for using them, this book provides a state-of-the-art look at this promising field. Using Mass Spectrometry
Download or read book Toxicokinetics written by and published by . This book was released on 1995 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:
