Electrically Assisted Transdermal and Topical Drug Delivery

This volume provides coverage assisted transdermal and topical delivery by mechanisms of iontophoresis, electroosmosis and electroporation. Other topics discussed are human and clinical studies with iontophoresis, such As Delivery Of Peptides, Proteins And Oligonucleotides, And Other developments.

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Writing Clinical Research Protocols: Ethical Considerations

This highly engaging guide for clinical researchers provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events. A valuable appendix includes a listing of web resources about research ethics as well as a glossary. This will be an invaluable resource for basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process. 

* Walks investigators and trainees through identification of the ethical aspects of each section of a clinical research protocol

* Includes a chapter containing Case Histories

* Contains information on conducting clinical research within the pharmaceutical industry

* An appendix includes internet resources and world wide web addresses for important research ethics documents and regulations 

* Chapter on 'Study Design and Methodology' purposely expanded to explicitly address biostatistical considerations

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Common Statistical Methods for Clinical Research with SAS Examples, Second Edition

Clinical researchers, with or without a statistical background, will find this book an invaluable aid in understanding the statistical methods cited most frequently in clinical protocols, statistical analysis plans, clinical and statistical reports, and medical journals. Written in a manner which leads the nonstatistician through each test by example, substantive details are presented which will benefit even the experienced data analysts. Introductory chapters provide elementary statistical concepts as applied to clinical trials and an overview of statistical inference, including discussions of power, sample size calculations, p-values and the logic behind hypothesis testing. Numerous examples from clinical research are worked through both manually and using SAS. Methods presented include t-tests, analysis of variance, repeated measures ANOVA, linear regression, analysis of covariance, non-parametric tests, binomial tests, chi-square test, Fisher's exact test, McNemar's test, Cochran-Mantel-Haenszel test, logistic regression, log-rank test, and Cox proportional hazards model.

Supports releases 6.08 and higher of SAS software.

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Fundamentals of Clinical Research - Statistics for Biology and Health

In recent years many introductory textbooks on clinical trial methodology have been published, some of which are excellent, in addition to a very extensive specialist literature. Nevertheless, here is a new book on methods and issues in clinical research. The objectives can be summarized in three points.

1. Integrate medical and statistical components of clinical research. 

2. Do justice to the operational and practical requirements of clinical research. 

3. Give space to the ethical implications of methodological issues in clinical research.

The scope of clinical research is to evaluate the effect of a treatment on the evolution of a disease in the human species. The treatment can be pharmacological, surgical, psychological/behavioral or organizational/logistic. The disease, intended as an impairment of a state of well-being or a condition capable of provoking such impairment over time, can be universally accepted as such (e.g. a cancer or a bone fracture) or perceived as such only by limited groups of individuals in a given cultural context (e.g. hair loss or weight gain). The course of the disease that ones wishes to change can be the one with no intervention or, more frequently, the one observed with the available treatment. The evaluation of the effect of a treatment on the course of a disease is a lengthy process, which progresses in increasingly complex stages.

A detailed coverage of the logistic, administrative and legal aspects of clinical research is outside the scope of this book. However, throughout the book we keep reminding the reader of these aspects because, as already mentioned, we firmly believe they have a crucial role in determining the success of a study. The history of clinical research is paved with relics of studies started with great pomp, riding great ideas and great hopes, which drowned miserably because of inadequate logistical preparation. In our experience, the excessive complexity of a clinical trial is the single most frequent cause of failure: the study is perfect on paper, but impossible to implement by patients and staff alike. The distance between the principal investigators and the reality of clinical research in its day-to-day practice is often the main cause of such disasters. We warmly encourage everyone involved in clinical research to get involved in the logistics of a study, learning from colleagues responsible for its practical conduct (clinical research associates, data managers, etc.) and to take part, in person, in the practical implementation of a trial before attempting to design a study protocol.

The book ends with a brief description of the drug development process and to the phases of clinical development.

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Drug Products for Clinical Trials: An Intl Guide to Formulation, Production, Quality Control

This practical guide shows how the appropriate use of clinical materials can increase efficiency in bringing new products to the marketplace;offering authoritative assessments of the scientific and legal issues involved in the successful completion of clinical trials for marketing approval by regulatory agencies. The only wide-ranging, up-to-date book of its kind available on the subject! Describing both the science and management of product development, Drug Products for Clinical Trials furnishes effective approaches for preclinical drug discovery addresses the function of the clinical trials materials manager covers the design of clinical protocols in developing a new chemical entity (NCE) explains the importance of bioequivalence between clinical trials materials and final products demonstrates rapid, reliable processes for clinical evaluation discusses the interaction between clinical research, manufacturing, and packaging reviews quality control strategies used in the manufacture of drug substances for clinical studies conducted throughout the world and much more!

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Opioid Research: Methods and Protocols

Univ. of Texas MD Anderson Cancer Center, Houston. Text provides a comprehensive collection of methods and protocols used in current opioid research. Covers molecular and genetic techniques and behavioral analysis of animal models. Provides state-of-the-art techniques plus clinical applications. For researchers and practitioners.

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Pharmaceutical Experimental Design

This useful reference describes the statistical planning and design of pharmaceutical experiments, covering all stages in the development process-including preformulation, formulation, process study and optimization, scale-up, and robust process and formulation development. Shows how to overcome pharmaceutical, technological, and economic constraints on experiment design! Directly comparing the advantages and disadvantages of specific techniques, Pharmaceutical Experimental Design · offers broad, detailed, up-to-date descriptions of designs and methods not easily accessible in other books · reviews screening designs for qualitative factors at different levels · presents designs for predictive models and their use in optimization · highlights optimization methods, such as steepest ascent, optimum path, canonical analysis, graphical analysis, and desirability · discusses the Taguchi method for quality assurance and approaches for robust scaling up and process transfer · details nonstandard designs and mixtures · analyzes factorial, D-optimal design, and offline quality assurance techniques · reveals how one experimental design evolves from another · and more! Featuring over 700 references, tables, equations, and drawings, Pharmaceutical Experimental Design is suitable for industrial, research, and clinical pharmaceutical scientists, pharmacists, and pharmacologists; statisticians and biostatisticians; drug regulatory affairs personnel; biotechnologists; formulation, analytical, and synthetic chemists and engineers, quality assurance personnel; all users of statistical experimental design in research and development; and postgraduate and postdoctoral research workers in these disciplines.

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Designing Clinical Research: An Epidemiologic Approach

Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This edition incorporates current research methodology--including molecular and genetic clinical research--and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing. All chapters have been thoroughly revised, updated, and made more user-friendly.

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Principles and Practice of Clinical Research, Second Edition

The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.

*Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research

*Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research

*Delves into data management and addresses how to collect data and use it for discovery

*Contains valuable, up-to-date information on how to obtain funding from the federal government

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Clinical Studies Management - A Practical Guide to Success

A comprehensive desk reference, this book provides an easy-to-read guide to the practical skills and methods required by project managers running clinical studies. The author uses a framework based on seven core themes: goals, budgets, time, resources, measurement, communication and training to present a solid review of how modern management theory can be brought to bear on the specialist demands of clinical trials. Coverage includes the R&D process, CROs, the Clinical Study Team, and QA audits. The book includes true-life case histories as well as a comprehensive overview of drug development processes and trends that are driving change. It is a resource for anyone who wishes to sharpen their study management skills.

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Practical Guide to Clinical Data Management

Clinical data management (CDM) has changed from being an essentially clerical task in the late 1970s and early 1980s to a highly computerized, highly specialized field today. Clinical data managers have had to adapt their data management systems and processes accordingly. Practical Guide to Clinical Data Management steers readers through the role of data management in clinical trials and includes more advanced topics such as CDM systems, SOPs, and quality assurance. It helps readers establish GCP, manage laboratory data, ensure that DMB systems are in compliance with federal regulations, and deal with the kinds of clinical data that can cause difficulties in database applications.

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http://rapidshare.com/files/126960497/Pra_gud_clin_dm2Ed.zip

Encyclopedia of Controlled Drug Delivery, 2 Volume Set

Covers all aspects of controlled drug delivery, including human, agricultural and animal applications. The 70 entries, written by an international team of renowned experts, offers A-to-Z coverage of controlled drug delivery systems for researchers in the pharmaceutical and biotechnology industries, agriculture companies, medical device companies, clinical research organizations and medical schools.

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