Statistical Evaluation Of Stability Study In Pharmaceuticals

Learn statistics to evaluate stability study according to ICH guidelines.

What you'll learn

Data Types (Continuous and Attribute)

Types of Statistics (Descriptive and Inferential)

Regression (Fitted Line, r, R-sr, residual, error)

Distribution (Histogram, Central Limit Theorem, Normality)

Poolability (CICS, SICS and SISS)

Confidence and Prediction Intervals

Treatment Factors (Fixed Factor and Random Factor)

Interaction Effect and Variation Effect

OOS/OOT/OOE (Definition and Treatment)

Special Cause and Common Cause

Shelf-life Determination

Internal Release Limit Calculation

Interpreting Minitab Results

Roadmap for Hypothesis Testing

Possilble Industry Problems and Their Solutions

Requirements

Any statistical backround required.

Basic knowledge of Stability Study in Pharmaceutical Industry.

Description

If you are a pharma professional searching for statistical knowledge to use it in your daily life, if you want to learn basic statistics, learn how to evaluate stability data, how to conduct hypothesis testing and more, this course is what you are looking for. You will get exact amount of statistical knowledge which you need in your daily work for stability study.Design of this course in fully compliant with ICH and detailed overview of guidelines will be done at the end of this course. After completing first part of this course you will learn:Data Types (Continuous and Attribute)Types of Statistics (Descriptive and Inferential)Hypothesis Testing (p-value, t-test, f-test, ANOVA, ANCOVA)Regression (Fitted Line, r, R-sq, residual, error)Distribution (Histogram, Central Limit Theorem, Normality)Poolability (CICS, SICS and SISS)Confidence and Prediction IntervalsTreatment Factors (Fixed Factor and Random Factor)Interaction Effect and Variation EffectOOS/OOT/OOE (Definition and Treatment)Special Cause and Common CauseThis is the basic knowledge that you need to start your statistical journey. After understanding these concepts, we will go to real examples, and you will learn:Shelf-life DeterminationInternal Release Limit CalculationInterpreting Minitab ResultsRoadmap for Hypothesis TestingPossible Industry Problems and Their SolutionsCase StudiesMinitab ExtrasIndustry TipsKnowledge you gained in course will help you not only for stability study, but also for a lot of different applications done in GMP environment each day.

Overview

Section 1: Introduction and General Information

Lecture 1 Introduction

Lecture 2 References

Lecture 3 Statistical Software for Stability Study

Lecture 4 Before Starting

Section 2: Basic Concepts

Lecture 5 Types of Statistics

Lecture 6 Origins of Variation

Lecture 7 Variation Effect in Stability Study

Lecture 8 Resgression and Fitted Line

Lecture 9 r and R-sq

Lecture 10 Residuals

Lecture 11 Regression in Minitab

Section 3: Hypothesis Testing

Lecture 12 Definition

Lecture 13 Alpha level and p-value

Lecture 14 Stages of Hypothesis Testing

Lecture 15 Types of Data

Lecture 16 Distribution

Lecture 17 Distribution in Minitab

Lecture 18 Normality

Lecture 19 Normality in Minitab

Lecture 20 Central Limit Theorem

Lecture 21 CLT in Minitab

Section 4: Types of Hypothesis Testing

Lecture 22 Roadmap for Hypothesis Testing

Lecture 23 t-test in Minitab

Lecture 24 f-test in Minitab

Lecture 25 One-way ANOVA in Minitab

Section 5: Statistical Terms for Stability Study

Lecture 26 Confidence Interval (CI)

Lecture 27 Prediction Interval (PI)

Lecture 28 Out-of-specification (OOS)

Lecture 29 Out-of-trend (OOT)

Lecture 30 Out-of-expectation (OOE)

Lecture 31 Interaction Effect

Lecture 32 Treatment Factors: Fixed Factor and Random Factor

Lecture 33 Data Collection for Statistical Evaluation of Stability Study

Lecture 34 Poolability

Lecture 35 Internal Release Limit (IRL)

Lecture 36 Internal Release Limit - Case Study

Section 6: Case Studies in Minitab

Lecture 37 Case-1 (Common Intercept Common Slope)

Lecture 38 Case-2 (Seperate Intercept Common Slope)

Lecture 39 Case-3 (Seperate Intercept Seperate Slope)

Lecture 40 Case-4 (Treatment with Random Factors)

Section 7: ICH Guidelines Overview

Lecture 41 ICH Q1A - Stability Testing of New Drug Substances and Products

Lecture 42 ICH Q1E - Evaluation for Stability Data

Section 8: Notes and Conclusion

Lecture 43 Notes and Tips

Lecture 44 Conclusion

Section 9: Final Quiz

Manufacturing Science and Technology Professionals,Research and Development Professionals,Quality Professionals,Pharma Professionals,Pharmacy Graduate Students