Sign-In
Cart
Statistical Design and Analysis of Stability Studies
Paperback
Series: Chapman & Hall/CRC Biostatistics
Medical ReferenceProbability & Statistics
ISBN13: 9780367577681
Publisher: Crc Pr Inc
Published: Jun 30 2020
Pages: 348
Weight: 1.23
Height: 0.80 Width: 6.10 Depth: 9.10
Language: English
The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how stability studies play an important role in drug safety and quality assurance, Statistical Design and Analysis of Stability Studies presents the principles and methodologies in the design and analysis of stability studies.
After introducing the basic concepts of stability testing, the book focuses on short-term stability studies and reviews several methods for estimating drug expiration dating periods. It then compares some commonly employed study designs and discusses both fixed and random batch statistical analyses. Following a chapter on the statistical methods for stability analysis under a linear mixed effects model, the book examines stability analyses with discrete responses, multiple components, and frozen drug products. In addition, the author provides statistical methods for dissolution testing and explores current issues and recent developments in stability studies.
To ensure the safety of consumers, professionals in the field must carry out stability studies to determine the reliability of drug products during their expiration period. This book provides the material necessary for you to perform stability designs and analyses in pharmaceutical research and development.
1 different editions
Also available
Also in
Probability & Statistics
R for Data Science: Import, Tidy, Transform, Visualize, and Model Data
Grolemund, Garrett
Wickham, Hadley
Paperback
AP Statistics Premium, 2027: 9 Practice Tests + Comprehensive Review + Online Practice
Sternstein, Martin, PH. D.
Paperback
R for Data Science: Import, Tidy, Transform, Visualize, and Model Data
Wickham, Hadley
Grolemund, Garrett
Cetinkaya-Rundel, Mine
Paperback
Graph Paper Composition Notebook: Quad Ruled 5x5, Grid Paper for Students in Math and Science
Wizo, Math
Paperback
Forecasting: Principles and Practice, the Pythonic Way
Hyndman, Rob J.
Athanasopoulos, George
Paperback
The Art of Uncertainty: How to Navigate Chance, Ignorance, Risk and Luck
Spiegelhalter, David
Paperback
Stat 208 Statistical Thinking: A Book for Stat 208 at Virginia Commonwealth University
Durfee, Becky
Street IV, W. Scott
Paperback
An Introduction to Statistical Learning: With Applications in R
Witten, Daniela
Hastie, Trevor
James, Gareth
Paperback
Mastering Claude AI: Practical Journey from First Prompts to Pro with Claude AI
Dickey, Ryan
Paperback
Introduction to Statistics: An Intuitive Guide for Analyzing Data and Unlocking Discoveries
Frost, Jim
Paperback
Ai-Assisted Statistics for Data Scientists: 50+ Essential Concepts Using R and Python
Bruce, Andrew
Gedeck, Peter
Bruce, Peter
Paperback
Scale: The Universal Laws of Life, Growth, and Death in Organisms, Cities, and Companies
West, Geoffrey
Paperback
How the World Really Works: The Science Behind How We Got Here and Where We're Going
Smil, Vaclav
Paperback
The Art of Uncertainty: How to Navigate Chance, Ignorance, Risk and Luck
Spiegelhalter, David
Hardcover
The Random Universe: How Models and Probability Help Us Make Sense of the Cosmos
Jaffe, Andrew H.
Hardcover
Schaum's Outline of Probability and Statistics, 4th Edition: 897 Solved Problems + 20 Videos
Srinivasan, R. Alu
Spiegel, Murray R.
Schiller, John J.
Paperback
Advanced Statistics in Research: Reading, Understanding, and Writing Up Data Analysis Results
Hatcher, Larry
Paperback
The Only Math Book You'll Ever Need, Revised Edition: Hundreds of Easy Solutions and Shortcuts for Mastering Everyday Numbers
Kogelman, Stanley
Heller, Barbara R.
Paperback
Schaum's Outline of Probability, Random Variables, and Random Processes, Fourth Edition
Hsu, Hwei P.
Paperback
Mathematical Foundations of Quantum Computing: A Scaffolding Approach
Cheng, Ran
Lee, Peter
Yu, James
Hardcover
The End of Average: Unlocking Our Potential by Embracing What Makes Us Different
Rose, Todd
Paperback
Mathletics: How Gamblers, Managers, and Fans Use Mathematics in Sports, Second Edition
Winston, Wayne L.
Nestler, Scott
Pelechrinis, Konstantinos
Paperback
Building Large Language Models from Scratch: Design, Train, and Deploy Llms with Pytorch
Grigorov, Dilyan
Paperback
Regression Modeling Strategies: With Applications to Linear Models, Logistic and Ordinal Regression, and Survival Analysis
Harrell Jr, Frank E.
Paperback
How the World Really Works: The Science Behind How We Got Here and Where We're Going
Smil, Vaclav
Hardcover
Damned Lies and Statistics: Untangling Numbers from the Media, Politicians, and Activists
Best, Joel
Hardcover
System Design with AI Interview Guide: Designing Scalable, Agentic, and Defensible Systems
Bhardwaj, Rohit
Paperback
Challenging Mathematical Problems with Elementary Solutions, Vol. I: Volume 1
Yaglom, I. M.
Yaglom, A. M.
Paperback
SQL Server 2025 Unveiled: The Ai-Ready Enterprise Database with Microsoft Fabric Integration
Ward, Bob
Paperback
Databricks Data Intelligence Platform: Unlocking the Genai Revolution
Yip, Jason
Gupta, Nikhil
Paperback
Quantum Computing and Quantum Machine Learning for Engineers and Developers
Fraser, Roydon Andrew
Van Griensven Thé, Jesse
Rosas-Bustos, Jose
Hardcover
The Master Algorithm: How the Quest for the Ultimate Learning Machine Will Remake Our World
Domingos, Pedro
Paperback
Large Language Models: A Deep Dive: Bridging Theory and Practice
Somers, Garrett
Kamath, Uday
Keenan, Kevin
Hardcover
Probably the Best Book on Statistics Ever Written: How to Beat the Odds and Make Better Decisions
Shapira, Haim
Hardcover
Making ChatGPT Work for You: Getting the Most Out of Generative AI as a Non-Techie
Evelyn, Lydia
Paperback
Probably Overthinking It: How to Use Data to Answer Questions, Avoid Statistical Traps, and Make Better Decisions
Downey, Allen B.
Paperback
The Theory That Would Not Die: How Bayes' Rule Cracked the Enigma Code, Hunted Down Russian Submarines, and Emerged Triumphant from Two Centuries of C
McGrayne, Sharon Bertsch
Paperback
Learning Statistics with Jamovi: A Tutorial for Beginners in Statistical Analysis
Navarro, Danielle
Foxcroft, David
Paperback
Time Series Analysis and Its Applications: With R Examples
Stoffer, David S.
Shumway, Robert H.
Hardcover
Probably Overthinking It: How to Use Data to Answer Questions, Avoid Statistical Traps, and Make Better Decisions
Downey, Allen B.
Hardcover
Machine Learning Q and AI: 30 Essential Questions and Answers on Machine Learning and AI
Raschka, Sebastian
Paperback
A Modern Introduction to Probability and Statistics: Understanding Why and How
Lopuhaä, H. P.
Dekking, F. M.
Kraaikamp, C.
Hardcover
Guide to Methods for Students of Political Science: Property, Proof, and Dispute in Catalonia Around the Year 1000
Van Evera, Stephen
Paperback
Scorecasting: The Hidden Influences Behind How Sports Are Played and Games Are Won
Wertheim, L. Jon
Moskowitz, Tobias
Paperback
Mathematical Modeling and Computation in Finance: With Exercises and Python and MATLAB Computer Codes
Grzelak, Lech A.
Oosterlee, Cornelis W.
Paperback
An Introduction to Statistical Learning: With Applications in Python
James, Gareth
Witten, Daniela
Hastie, Trevor
Hardcover
Mathematical Foundations of Quantum Computing: A Scaffolding Approach
Cheng, Ran
Lee, Peter
Yu, James
Paperback
Modern Time Series Forecasting with Python - Second Edition: Industry-ready machine learning and deep learning time series analysis with PyTorch and p
Joseph, Manu
Tackes, Jeffrey
Paperback
Observability for Large Language Models: Site Reliability and Chaos Engineering for AI at Scale
Sharma, Ankush
Paperback
AI for Robotics: Toward Embodied and General Intelligence in the Physical World
Gopalakrishnan, Keerthana
Imran, Alishba
Paperback
Challenging Mathematical Problems with Elementary Solutions, Vol. II: Volume 2
Yaglom, A. M.
Yaglom, I. M.
Paperback
ACCUPLACER Math Prep: ACCUPLACER Math Test Study Guide with Two Practice Tests [Includes Detailed Answer Explanations]
Tpb Publishing
Paperback
Prompt Engineering for Everyone: A Self-Taught, Human-Centered Approach to AI Programming
Tavakoli, Hamid
Paperback
The Design Inference: Eliminating Chance through Small Probabilities
Dembski, William A.
Ewert, Winston
Hardcover
High-Dimensional Probability: An Introduction with Applications in Data Science
Vershynin, Roman
Hardcover
Discrete Nonlinear Schrodinger Equation: Beyond Complete Integrability
Zhang, Guoping
Pankov, Alexander
Hardcover
Introduction to Statistics: An Intuitive Guide for Analyzing Data and Unlocking Discoveries
Frost, Jim
Hardcover
The Elements of Statistical Learning: Data Mining, Inference, and Prediction, Second Edition
Hastie, Trevor
Tibshirani, Robert
Friedman, Jerome
Hardcover
Large Language Model Recipes: A Hands-On Guide to Fine-Tuning, Optimization, Deployment, and Real-World Applications
Bolla, Bharath Kumar
Subbaiah, Kalpa
Kaata, Sashi Kiran
Paperback
Unlocking Dbt: Design and Deploy Transformations in Your Cloud Data Warehouse
Cyr, Cameron
Dorsey, Dustin
Paperback
Bayesian Analysis with Python - Third Edition: A practical guide to probabilistic modeling
Martin, Osvaldo
Paperback
The ESRI Guide to GIS Analysis, Volume 2: Spatial Measurements and Statistics
Mitchell, Andy
Griffin, Lauren Scott
Paperback
Telling Time Workbook: Practice Reading and Draw the Hand on the Clocks One Hour Half Hour 15 5 1 Minutes
Winny, Renzo
Paperback
Databricks Data Intelligence Platform: Powering the Agentic Era
Gupta, Nikhil
Wojtyczka, Marcin
Yip, Jason
Paperback
R in Action, Third Edition: Data Analysis and Graphics with R and Tidyverse
Kabacoff, Robert I.
Paperback
Building Generative AI Agents: Using Langgraph, Autogen, and Crewai
Taulli, Tom
Deshmukh, Gaurav
Paperback
Making Statistics Work: Information Theory and Bayesian Inference
Foley, Duncan
Scharfenaker, Ellis
Paperback
Transformation Enterprise Architecture with Agentic AI: Designing Intelligent, Adaptive, and Self-Governing Systems
Goniwada, Shivakumar R.
Paperback
Deep Learning in Computational Mechanics: An Introductory Course
Weeger, Oliver
Jokeit, Moritz
Herrmann, Leon
Hardcover
The Practical Guide to Large Language Models: Hands-On AI Applications with Hugging Face Transformers
Gridin, Ivan
Paperback