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1.2.1 Installation Qualification (IQ) 1.2.2 Operational Qualification (OQ) 1.2.3Performance Qualification (PQ) 2. Method Development, Optimization, and Validation Approaches 2.1. Method Development 2.2. Optimization 2.3. Method Validation Approaches 2.3.1. The Zero-Blind Method 2.3.2. The Single-Blind Method 2.3.3. The Double-Blind Method 2.3.4. The Analysis of Standard Reference Materials 2.3.5. The Interlaboratory Collaborative Study 2.3.6. Comparisons with a Currently Accepted Method 2.4. Step-by-Step HPLC Method Development, Optimization, and Validation: An Outline 3. Method Validation (USP/ICH) 3.1. Terminology and Definitions 3.1.1. Accuracy 3.1.2. Precision 3.1.3. Specificity 3.1.4. Limit of Detection

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