Search results for ""Author Richard Kay""

STATISTICAL THINKING FOR NON-STATISTICIANS IN DRUG REGULATION Statistical methods in the pharmaceutical industry are accepted as a key element in the design and analysis of clinical studies. Increasingly, the medical and scientific community are aligning with the regulatory authorities and recognizing that correct statistical methodology is essential as the basis for valid conclusions. In order for those correct and robust methods to be successfully employed there needs to be effective communication across disciplines at all stages of the planning, conducting, analyzing and reporting of clinical studies associated with the development and evaluation of new drugs and devices. Statistical Thinking for Non-Statisticians in Drug Regulation provides a comprehensive in-depth guide to statistical methodology for pharmaceutical industry professionals, including physicians, investigators, medical science liaisons, clinical research scientists, medical writers, regulatory personnel, statistical programmers, senior data managers and those working in pharmacovigilance. The author’s years of experience and up-to-date familiarity with pharmaceutical regulations and statistical practice within the wider clinical community make this an essential guide for the those working in and with the industry. The third edition of Statistical Thinking for Non-Statisticians in Drug Regulation includes: A detailed new chapter on Estimands in line with the 2019 Addendum to ICH E9 Major new sections on topics including Combining Hierarchical Testing and Alpha Adjustment, Biosimilars, Restricted Mean Survival Time, Composite Endpoints and Cumulative Incidence Functions, Adjusting for Cross-Over in Oncology, Inverse Propensity Score Weighting, and Network Meta-Analysis Updated coverage of many existing topics to reflect new and revised guidance from regulatory authorities and author experience Statistical Thinking for Non-Statisticians in Drug Regulation is a valuable guide for pharmaceutical and medical device industry professionals, as well as statisticians joining the pharmaceutical industry and students and teachers of drug development.

Read more less

Dante's Comedy is a puzzling poem because the author wanted to lead his readers to understanding by engaging their curiosity. While many obscure matters are clarified in the course of the poem itself, others have remained enigmas that have fascinated Dantists for centuries. Over the last thirty-five years, Richard Kay has proposed original solutions to many of these puzzles; these are collected in the present volume. Historical context frames Kay's readings, which relate the poem to such standard sources as the Bible, Aristotle, Aquinas, and the Latin classics, but he also goes beyond these Scholastic sources to exploit Dante's use of less familiar aspects of Latin clerical culture, including physiognomy, Vitruvian proportions, and optics, and most especially astrology. Kay explores new ways to read the Comedy. For instance, he argues that Dante has embedded references to his authorities in a continuous series of acrostics formed by the initial letters of each tercet. Again, he shows how Dante returns to the theme of each infernal canto and develops it in the parallel cantos of Purgatorio and Paradiso. Particularly worthy of note are four essays on the poem's finale in the Empyrean.

Read more less

The controlled clinical trial has become an essential part of the clinician's decision-making process. Clinical trials, however, still raise methodological problems that are important and at the same time controversial: subgroup analysis and interactions, meta-analy­ sis of similar trials, consideration of subjective clinical opinions and those of the public at large, assessment of quality of life, pre­ vention trials, and so on. In February 1987 we took our third step along the road to evaluating these issues in dialogues between cli­ nicians, psychologists, legal experts, and statisticians. The talks presented at the meeting were revised by the authors afterwards and have been rearranged by the editors to form a strictly organ­ 1 2 ized book. The two preceding meetings in 1978 and 1981 focused strongly on adjuvant therapy in primary breast cancer, but this top­ ic served merely as a nucleus in the third meeting. This meeting, although called the Third Heidelberg Symposium was forced to leave Heidelberg and in fact was held in Freiburg. Without the interest and enthusiasm of Professor Martin Schu­ macher and his colleagues in Freiburg the meeting would never have taken place. The meeting was generously supported again by the Federal Ministry of Research and Technology (Bundesministe­ rium flir Forschung und Technologie, BMFT) within the framework of the West German BMFT Breast Cancer Study Group. We are grateful, in particular, to Mr. Hans W. Herzog for his personal in­ volvement. Juni 1988 H. Scheurlen, R. Kay, M.

Read more less

Originally published in 1993, A Guide to Kansas Mushrooms went out of print in 2017. Original author Richard Kay suggested his wife, Sherry Kay, could assume the undertaking of revising the book, collaborating with him working as a consultant. After Richard’s death in 2018, Sherry later added two coauthors, Benjamin Sikes and Caleb Morse, to complete the task.Kay, Sikes, and Morse have revised this new edition to account for the variety of ways mycology has changed in the last twenty-five years, while holding to its original purpose as a guide for active mushroomers. Primarily, A New Guide to Kansas Mushrooms highlights the upheaval in taxonomy caused by advances in molecular genetics: an estimated 25 percent of fungal names included in the original guide have changed since 1993. Second, the list of mushrooms found in Kansas has expanded and the new edition will add 50 species to the 150 described in the original guide. All anthology entries have been updated to reflect these changes in the field, and the essays have also been edited, reduced, or expanded to include updated information as well as brand-new material. The outdated genus-level classification of fungi has been replaced by two cladograms—diagrams that illustrate how organisms branch off from their last common ancestors.This revised edition provides a wealth of new material on Kansas mushrooms that will aid and fascinate both newbies and seasoned mycophiles and includes information on online resources and notes on how to grow mushrooms in Kansas. While the book fully treats 200 species, readers will be able to identify 320 different macrofungi using the keys and discussions. Additionally, the book introduces readers to fascinating, common slime molds (myxomycetes). A New Guide to Kansas Mushrooms incorporates new understanding of fungal taxonomy that has been largely unearthed by genetic tools over the past three decades, highlights key taxa, and includes a life list of the more than 1,200 species now cataloged from Kansas—nearly twice the number known at the time of the first edition.

Read more less