Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition explores statistics used in day-to-day clinical pharmacology work. The book is a starting point for those involved in such research and covers the methods needed to design, analyze, and interpret bioequivalence trials; explores when, how, and why these studies are performed as part of drug development; and demonstrates the methods using real world examples. Drawing on knowledge gained directly from working in the pharmaceutical industry, the authors set the stage by describing the general role of statistics. Once the foundation of clinical pharmacology drug development, regulatory applications, and the design and analysis of bioequivalence trials are established, including recent regulatory changes in design and analysis and in particular sample-size adaptation, they move on to related topics in clinical pharmacology involving the use of cross-over designs. These include, but are not limited to, safety studies in Phase I, dose-response trials, drug interaction trials, food-effect and combination trials, QTc and other pharmacodynamic equivalence trials, proof-of-concept trials, dose-proportionality trials, and vaccines trials. This second edition addresses several recent developments in the field, including new chapters on adaptive bioequivalence studies, scaled average bioequivalence testing, and vaccine trials. Purposefully designed to be instantly applicable, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition provides examples of SAS and R code so that the analyses described can be immediately implemented. The authors have made extensive use of the proc mixed procedures available in SAS.

Design and Analysis of Cross-Over Trials is concerned with a specific kind of comparative trial known as the cross-over trial, in which subjects receive different sequences of treatments. Such trials are widely used in clinical and medical research, and in other diverse areas such as veterinary science, psychology, sports science, and agriculture. The first edition of this book was the first to be wholly devoted to the subject. The second edition was revised to mirror growth and development in areas where the design remained in widespread use and new areas where it had grown in importance. This new Third Edition: Contains seven new chapters written in the form of short case studies that address re-estimating sample size when testing for average bioequivalence, fitting a nonlinear dose response function, estimating a dose to take forward from phase two to phase three, establishing proof of concept, and recalculating the sample size using conditional power Employs the R package Crossover, specially created to accompany the book and provide a graphical user interface for locating designs in a large catalog and for searching for new designs Includes updates regarding the use of period baselines and the analysis of data from very small trials Reflects the availability of new procedures in SAS, particularly proc glimmix Presents the SAS procedure proc mcmc as an alternative to WinBUGS for Bayesian analysis Complete with real data and downloadable SAS code, Design and Analysis of Cross-Over Trials, Third Edition provides a practical understanding of the latest methods along with the necessary tools for implementation.

Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition explores statistics used in day-to-day clinical pharmacology work. The book is a starting point for those involved in such research and covers the methods needed to design, analyze, and interpret bioequivalence trials; explores when, how, and why these studies are performed as part of drug development; and demonstrates the methods using real world examples. Drawing on knowledge gained directly from working in the pharmaceutical industry, the authors set the stage by describing the general role of statistics. Once the foundation of clinical pharmacology drug development, regulatory applications, and the design and analysis of bioequivalence trials are established, including recent regulatory changes in design and analysis and in particular sample-size adaptation, they move on to related topics in clinical pharmacology involving the use of cross-over designs. These include, but are not limited to, safety studies in Phase I, dose-response trials, drug interaction trials, food-effect and combination trials, QTc and other pharmacodynamic equivalence trials, proof-of-concept trials, dose-proportionality trials, and vaccines trials. This second edition addresses several recent developments in the field, including new chapters on adaptive bioequivalence studies, scaled average bioequivalence testing, and vaccine trials. Purposefully designed to be instantly applicable, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition provides examples of SAS and R code so that the analyses described can be immediately implemented. The authors have made extensive use of the proc mixed procedures available in SAS.

This interactive book is designed specifically for church leaders--clergy, staff, and laity. Each week, readers experience three different meditations or exercises. Readers can approach the material in whatever way works best for them--on a regular schedule (Monday, Wednesday and Saturday, for instance) or in whatever way works best in any given week. The three-per-week meditations build upon themes, with an ebb and flow allowing the reader to experience the material more deeply. The fact that this is not a daily exercise is distinctive, as many devotional books are regimented and overwhelming, with an expectation of a daily commitment. Refill's format is designed to be viable, accessible, and nurturing for busy leaders. Each page contains a nugget of wisdom about how leaders can tap into inner capacities they already possess, but which are often overlooked. These capacities include awareness, stillness, and playfulness (as we learned of in Fulfilled) but the author also includes other capacities, such as compassion, empathy, and creativity.

Leadership can be mentally, emotionally, and spiritually exhausting. The pace is relentless. The expectations are weighty. The challenges are daunting. But it is possible to live and lead a new way, with that deep sense of contentment that all leaders yearn for. It is possible to be fulfilled, even today. Fulfilled articulates a new approach for the exhausted leader. This Christian theology of leadership is based on three inner capacities, which every leader already possesses but which most of us simply ignore or disregard: stillness, awareness, and playfulness. Kirk Byron Jones examines these capacities and shows the reader how to draw upon them in daily life. Vibrant leadership taps into this wellspring of inner capacities, continually available to every leader. It is not the exclusive possession of the gifted, faithful few, but is a grace provided for all. The fulfilled leader lives in wisdom, peace and joy, and is successful in all the most important ways.

Get inspired with thought-provoking and heartwarming quotes: A leaf said to me as it fell, "I'm not falling; I'm fl ying " Dare to soar joyfully in this new day, because each day an angel comes to us, arms wide open, bearing God's infi nite grace. Sometimes we can't see grace because we're standing right smack in the middle of it. Take heart; no trial lasts forever, and there's a lesson in every storm. For a long moment, step away from all the "you shoulds," and savor you, as you are now. The heaviest thing in the world to carry is a grudge. Give grace a chance.

Many are living on the frazzled edge: overstretched, overbooked, and about to snap. From over-loaded students, to burdened-down moms, to over-worked business persons, we need help burning brightly in the world without burning out. Say Yes to Grace offers 7 Grace Solutions for 7 Great Stressors:
1. Fatigue----Learn to Rest.
2. Low Self-Esteem----Live from Acceptance not for Acceptance.
3. Disappointment----Loosen Strings to Needs and Expectations.
4. Hurry----Live at a Sacred Pace.
5. Worry----Claim Your Inner Calm.
6. Unhappiness----Balance Aspiration with Contentment.
7. Fear----Believe in God Beyond "God."
In a warm hearted, compassionate, and supportive book, bestselling author, Dr. Kirk Byron Jones, offers liberating ideas and life-changing practices that will help readers balance rigor with respite, performance with pause, and human grit with God's grace.
"Don't Let the Grind Wear You Down; Grace Yourself "

Many are living on the frazzled edge: overstretched, overbooked, and about to snap. From over-loaded students, to burdened-down moms, to over-worked business persons, we need help burning brightly in the world without burning out. Say Yes to Grace offers 7 Grace Solutions for 7 Great Stressors:
1. Fatigue----Learn to Rest.
2. Low Self-Esteem----Live from Acceptance not for Acceptance.
3. Disappointment----Loosen Strings to Needs and Expectations.
4. Hurry----Live at a Sacred Pace.
5. Worry----Claim Your Inner Calm.
6. Unhappiness----Balance Aspiration with Contentment.
7. Fear----Believe in God Beyond "God."
In a warm hearted, compassionate, and supportive book, bestselling author, Dr. Kirk Byron Jones, offers liberating ideas and life-changing practices that will help readers balance rigor with respite, performance with pause, and human grit with God's grace.
"Don't Let the Grind Wear You Down; Grace Yourself "

What if preachers were as contagiously joyful in their preaching as Louis Armstrong was in his playing and singing? As rich in their sermonic renderings as Sarah Vaughan was in her musical vocals? As honest about heartache as Billie Holiday was every time she sang about the blues of life? As alluringly clear as the angelic voice of Ella Fitzgerald? As tenaciously uninhibited in the action of creating as Duke Ellington? Of course, this is too much to ask of people, even those called by God. However, it is not too much to ask this question: Can preaching be enhanced through the metaphor of jazz? Can an understanding of the inner dynamics of jazz--its particular forms, rules, and styles, inform one's practice of preaching as well? Can jazz's simultaneous structure and spontaneity help preachers better understand their own art? The answer to these questions, says Jones, is an unqualified yes. He explains how one can dramatically improve one's preaching through understanding and applying key elements of the musical art form known as jazz. No musical background is necessary; all examples are well explained and tied in with preaching. The key elements include innovation (what one commentator refers to as "the experimental disposition of jazz"), improvisation, rhythm, call and response, honesty about heartaches, and delight. After dismissing the reality and role of each of these elements in jazz, and how they can be important for preaching as well, each chapter concludes by including five exercises for applying the jazz element to preaching preparation and performance. Drawing on a deep love of jazz and enlivening the discussion with insights drawn from the realities of African Americanpreaching, Jones introduces readers to rich and rewarding possibilities for constructing and delivering the sermon.

Statistical inference is the foundation on which much of statistical practice is built. This book covers the topic at a level suitable for students and professionals who need to understand these foundations.

Unlike other morning devotions, in which readers digest the words of others, this book teaches readers how to create their own devotional experiences through silence and prayer visualization.