Sign-In
Cart
Statistical Thinking for Non-Statisticians in Drug Regulation
Hardcover
ISBN13: 9781119867388
Publisher: Blackwell Publ
Published: Feb 28 2023
Pages: 432
Weight: 1.95
Height: 0.94 Width: 6.69 Depth: 9.61
Language: English
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.
Also in
Medical Reference
Virus Hunter: Thirty Years of Battling Hot Viruses Around the World
Peters, C. J.
Olshaker, Mark
Paperback
The Body Keeps the Score: Brain, Mind, and Body in the Healing of Trauma
Van Der Kolk, Bessel
Paperback
Overcoming Acute and Chronic Pain: Keys to Treatment Based on Your Emotional Type
Dibra, Sebhia Marie
Micozzi, Marc S.
Paperback
The New Menopause: Navigating Your Path Through Hormonal Change with Purpose, Power, and Facts
Haver, Mary Claire
Hardcover
Nursing Teas 7: A Quickstudy Laminated Reference Guide
Davis, April Michelle
Henry, Julie
Herrin, Jennifer
Other
It Hurts When I Poop!: A Story for Children Who Are Scared to Use the Potty
Bennett, Howard J.
Hardcover
Working The Roots: Over 400 Years of Traditional African American Healing
Lee, Michele Elizabeth
Paperback
How to Forage for Mushrooms Without Dying: An Absolute Beginner's Guide to Identifying 29 Wild, Edible Mushrooms
Hyman, Frank
Paperback
The Complete Native American Healing Herbs Encyclopedia - 7 Books in 1
Garcia Navarro, Hialeah
Paperback
Heal Your Gut, Save Your Brain: The Five Pillars of Enhancing Your Gut and Optimizing Your Cognitive Health
Nandi, Partha
Hardcover
The Ultimate Survival Medicine Guide: Emergency Preparedness for Any Disaster
Alton, Amy
Alton, Joseph
Paperback
Shoulder Pain? The Solution & Prevention: Fifth Edition, Revised & Expanded
Kirsch, John M.
Paperback
Period Repair Manual: Natural Treatment for Better Hormones and Better Periods
Briden Nd, Lara
Paperback
Longevity Guidebook: How to Slow, Stop, and Reverse Aging - and NOT Die from Something Stupid
Diamandis, Peter H.
Hardcover
Murder by Injection: The Story of the Medical Conspiracy Against America
Mullins, Eustace Clarence
Paperback
The Dysautonomia Project: Understanding Autonomic Nervous System Disorders for Physicians and Patients
Goldstein, Phd
Thompson, Charles R.
Freeman, Msm Kelly
Paperback
Integrating a Palliative Approach Workbook 2nd Edition, Revised: Essentials For Personal Support workers
Murray, Katherine
Paperback
The Good Death: A Guide for Supporting Your Loved One Through the End of Life
O'Brien, Suzanne B.
Hardcover
What Happened to You?: Conversations on Trauma, Resilience, and Healing
Perry, Bruce D.
Winfrey, Oprah
Hardcover
The Vaccine-Friendly Plan: Dr. Paul's Safe and Effective Approach to Immunity and Health-From Pregnancy Through Your Child's Teen Years
Thomas, Paul
Margulis, Jennifer
Paperback
Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (Dsm-5-Tr(r))
American Psychiatric Association
Paperback
Desk Reference to the Diagnostic Criteria from Dsm-5-Tr(r)
American Psychiatric Association
Paperback
Ob/GYN Peds Notes: Nurse's Clinical Pocket Guide
Holloway, Brenda Walters
Moredich, Cheryl
Kratovil, Amanda
Paperback
The Winning Brief: 100 Tips for Persuasive Briefing in Trial and Appellate Courts
Garner, Bryan A.
Hardcover
The 36-Hour Day: A Family Guide to Caring for People Who Have Alzheimer Disease and Other Dementias
Mace, Nancy L.
Rabins, Peter V.
Paperback
Clean -- Expanded Edition: The Revolutionary Program to Restore the Body's Natural Ability to Heal Itself
Junger, Alejandro
Paperback
Current Medical Diagnosis and Treatment 2025
Rabow, Michael W.
McQuaid, Kenneth R.
Papadakis, Maxine A.
Paperback
Estrogen Matters: Why Taking Hormones in Menopause Can Improve and Lengthen Women's Lives -- Without Raising the Risk of Breast Cancer (2024 Revised a
Bluming, Avrum
Tavris, Carol
Hardcover
All Creatures Great and Small: The Warm and Joyful Memoirs of the World's Most Beloved Animal Doctor
Herriot, James
Paperback
The Pfizer Papers: Pfizer's Crimes Against Humanity
The Warroom/Dailyclout Pfizer Documents Analysts
Hardcover
The Mindful Self-Compassion Workbook: A Proven Way to Accept Yourself, Build Inner Strength, and Thrive
Neff, Kristin
Germer, Christopher
Paperback
God's Hotel: A Doctor, a Hospital, and a Pilgrimage to the Heart of Medicine
Sweet, Victoria
Paperback
Anatomy Coloring Book with 450+ Realistic Medical Illustrations with Quizzes for Each
Wise, Eric
McCann, Stephanie
Paperback
Reversing Alzheimer's: The New Toolkit to Improve Cognition and Protect Brain Health
Sandison, Heather
Hardcover
Booster Shots: The Urgent Lessons of Measles and the Uncertain Future of Children's Health
Ratner, Adam
Hardcover
Dying of Whiteness: How the Politics of Racial Resentment Is Killing America's Heartland
Metzl, Jonathan M.
Paperback
Plain Language Big Book: A Tool for Reading Alcoholics Anonymous
Alcoholics Anonymous World Services Inc
Paperback
Dho Health Science, Student Workbook
Simmers, Louise
Simmers-Nartker, Karen
Simmers-Kobelak, Sharon
Paperback
The End of Alzheimer's Program: The First Protocol to Enhance Cognition and Reverse Decline at Any Age
Bredesen, Dale
Paperback
Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present
Washington, Harriet A.
Paperback
Mastering Diabetes: The Revolutionary Method to Reverse Insulin Resistance Permanently in Type 1, Type 1.5, Type 2, Prediabetes, and Gesta
Khambatta, Cyrus
Barbaro, Robby
Paperback
Mindful Self-Compassion for Burnout: Tools to Help You Heal and Recharge When You're Wrung Out by Stress
Neff, Kristin
Germer, Christopher
Paperback
Taking Charge of Adult ADHD: Proven Strategies to Succeed at Work, at Home, and in Relationships
Barkley, Russell A.
Paperback
Another World Is Possible: Lessons for America from Around the Globe
Hakimi Zapata, Natasha
Hardcover
Dissolving Illusions: Disease, Vaccines, and The Forgotten History
Bystrianyk, Roman
Humphries, Suzanne
Paperback
The Apothecary's Wife: The Hidden History of Medicine and How It Became a Commodity
Gevirtz, Karen Bloom
Hardcover
Pcos SOS: A Gynecologist's Lifeline To Naturally Restore Your Rhythms, Hormones, and Happiness
Gersh, Felice
Perella, Alexis
Paperback
Other Minds: The Octopus, the Sea, and the Deep Origins of Consciousness
Godfrey-Smith, Peter
Paperback
The Boy Who Was Raised as a Dog: And Other Stories from a Child Psychiatrist's Notebook -- What Traumatized Children Can Teach Us about Loss, Love, an
Szalavitz, Maia
Perry, Bruce D.
Paperback
Yin & Yang Nutrition for Dogs: Maximizing Health with Whole Foods, Not Drugs
Grant, Hue
Morgan DVM, Judy
Paperback
Child Medication Fact Book for Psychiatric Practice, Second Edition
Puzantian, Talia
Tien, Elizabeth
Feder, Joshua D.
Paperback
How to Change Your Mind: What the New Science of Psychedelics Teaches Us about Consciousness, Dying, Addiction, Depression, and Transcendence
Pollan, Michael
Paperback
Trauma and Recovery: The Aftermath of Violence--From Domestic Abuse to Political Terror
Herman, Judith Lewis
Paperback
Cialis Men's Usage Manual: Men's Long-Lasting Erection Pills: Quick-acting, Stay and Get Rock Hard, Unadulterated Mind-Blowing Climax
Petersson, Nicolas
Paperback
The New Evil: Understanding the Emergence of Modern Violent Crime
Brucato, Gary
Stone, Michael E.
Paperback
The Addictive Personality: Understanding the Addictive Process and Compulsive Behavior
Nakken, Craig
Paperback
Stem Cell Therapy: A Rising Tide: How Stem Cells Are Disrupting Medicine and Transforming Lives
Riordan, Neil H.
Paperback
Judas Dentistry: How Dentists Scorn Science, Break the Hippocratic Oath, and Wreck Their Patients' Minds and Bodies
Yoho, (Ret) Robert
Paperback
Hidden Epidemic: Silent Oral Infections Cause Most Heart Attacks and Breast Cancers
Levy, Jd
Paperback
Mayo Clinic Guide to Better Sleep: Find Relief from Insomnia, Sleep Apnea and Other Sleep Disorders
Prakash Kolla, Bhanu
Morgenthaler, Timothy I.
Hardcover
Cocktail Codex: Fundamentals, Formulas, Evolutions [A Cocktail Recipe Book]
Kaplan, David
Fauchald, Nick
Day, Alex
Hardcover
Everything Is Tuberculosis: The History and Persistence of Our Deadliest Infection (Large Print Edition)
Green, John
Paperback
The Anti-Inflammatory Diet Slow Cooker Cookbook: Prep-And-Go Recipes for Long-Term Healing
Given, Madeline
Paperback
Surviving Cancer, COVID-19, and Disease: The Repurposed Drug Revolution (Large Print Edition)
Hope, Justus R.
Paperback
The Forgotten Sense: The New Science of Smell--And the Extraordinary Power of the Nose
Olofsson, Jonas
Hardcover
A Parent's Guide to Starting Psychiatric Medications for Kids: Start Low and Go Slow
Trelles, Pilar
Jaffe, Robert
Kolevzon, Alexander
Paperback
The Obesity Code: Unlocking the Secrets of Weight Loss (Why Intermittent Fasting Is the Key to Controlling Your Weight)
Fung, Jason
Paperback
Get What's Yours for Medicare - Revised and Updated: Maximize Your Coverage, Minimize Your Costs
Moeller, Philip
Hardcover
You Are Not Broken: A Compassionate Guide to Uncovering Inner Wisdom and Transforming Your Life with Hypnotherapy
Raymond, Sara
Paperback
Anger Management Skills Workbook for Kids: 40 Awesome Activities to Help Children Calm Down, Cope, and Regain Control
Robinson, Amanda
Paperback
Fasting Cancer: How Fasting and Nutritechnology Are Creating a Revolution in Cancer Prevention and Treatment
Longo, Valter
Hardcover
Witches, Midwives, & Nurses (Second Edition): A History of Women Healers
English, Deirdre
Ehrenreich, Barbara
Paperback
Destiny of the Republic: A Tale of Madness, Medicine and the Murder of a President
Millard, Candice
Paperback
Herbal Medicine for Beginners: Your Guide to Healing Common Ailments with 35 Medicinal Herbs
Swift, Katja
Midura, Ryn
Paperback
It Starts with the Egg: The Science of Egg Quality for Fertility, Miscarriage, and IVF (Third Edition)
Fett, Rebecca
Paperback
Misoprostol En La Interrupcion Temprana del Embarazo En Adolescentes
Varona Sanchez Joel Alejandro
Paperback
Earthing (2nd Edition): The Most Important Health Discovery Ever!
Ober, Clinton
Sinatra, Stephen T.
Zucker, Martin
Paperback
Accessing the Healing Power of the Vagus Nerve: Self-Help Exercises for Anxiety, Depression, Trauma, and Autism
Rosenbery, Stanley
Paperback
Women in White Coats: How the First Women Doctors Changed the World of Medicine
Campbell, Olivia
Paperback
A Brief History of Intelligence: Evolution, Ai, and the Five Breakthroughs That Made Our Brains
Bennett, Max S.
Hardcover
I Hate Myself: Overcome Self-Loathing and Realize Why You're Wrong about You
Aguirre, Blaise
Hardcover
EMT Exam Prep, Seventh Edition: Focused Prep Book and Study Guide for the Nremt Cognitive Exam
Kaplan Medical
Paperback
The Living Medicine: How a Lifesaving Cure Was Nearly Lost--And Why It Will Rescue Us When Antibiotics Fail
Zeldovich, Lina
Hardcover
Balance Your Hormones, Balance Your Life: Achieving Optimal Health and Wellness Through Ayurveda, Chinese Medicine, and Western Science
Welch, Claudia
Paperback
Rumbles: A Curious History of the Gut: The Secret Story of the Body's Most Fascinating Organ
Richardson, Elsa
Hardcover
Cancer as a metabolic disease. An overview.: On the Origin, Management and Prevention of Cancer. Student Edition
Rockermeier, Johannes
Paperback
The Black Angels: The Untold Story of the Nurses Who Helped Cure Tuberculosis
Smilios, Maria
Hardcover