Online resources relevant to Biotechnology

Below are links to resources that may be of use to practitioners in the field of Biotechnology. This list is a subset of the links listed throughout this website, and is not meant to be exhaustive. A list of certain definitions provided by the US Food and Drug Administration is available through this link.

Please forward links to other resources you think should be on this site to me via: feedback@keithbower.com.

Foundations

• Definitions of Key Biotech Terms
• Some Misconceptions about Confidence Intervals
• Some Misconceptions about R²
• What is a P-Value?
• What is Statistical Power?
• Why We Don’t “Accept” the Null Hypothesis

Methods for Statistical Analysis

• Analysis of Variance (ANOVA)
• Gosset's t-Test
• One Sample t-Test
• The Paired t-Test

Concepts Associated with the Design and Analysis of Experiments (DOE)

• Interaction Effects in Designed Experiments
• Model Reduction in Designed Experiments
• One-Factor-at-a Time Versus Designed Experiments
• Randomization in Designed Experiments
• What are Fractional Factorial Designs?

U.S. Food and Drug Administration Guidelines; more extensive list available via this link

• International Conference on Harmonisation (ICH); Guidance for Industry: Q2B Validation of Analytical Procedures: Methodology (5/19/1997)
• International Conference on Harmonisation (ICH); Draft Guidance: Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC) (8/7/2006)
• International Conference on Harmonisation (ICH); Guidance for Industry: Q1E Evaluation of Stability Data (6/7/2004)
• International Conference on Harmonisation (ICH); Guidance for Industry: Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process - 6/29/2005
• International Conference on Harmonisation (ICH); Guidance for Industry: Q8 Pharmaceutical Development (5/19/2006)
• International Conference on Harmonisation (ICH); Guidance for Industry: Q9 Quality Risk Management (6/1/2006)

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