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Chapter
- DEFINITION OF METHODS VALIDATION
- WHY VALIDATION ANALYTICAL PROCEDURE ?
- APPROACH OF VALIDATION
- STEPS IN METHOD VALIDATION
- SCOPE OF ANALYTICAL METHOD VALIDATION .
- TYPES OF ANALYTICAL PROCEDURES TO BE VALIDATED
- VALIDATION CHARACTERISTICS WHICH SHOULD BE CONSIDERED ARE
- ICH, USP, AND FDA METHODS VALIDATION CHARACTERISTICS REQUIREMENTS FOR VARIOUS TYPES OF TESTS
- WRITING A TEST METHOD VALIDATION PROTOCOL
- INSTRUCTION FOR EVALUATION
- EVALUATION QUESTIONNAIRE
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