About Analytical and Technological Reasons of Out-of-Specification Results for Assay and Disolution Tests (Review) by N. A. Epshtein

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INTERMEDIATE PRECISION DETERMINATION AT VALIDATION OF METHODS IN PHARMACY by N. A. Epshtein

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Validation of Chromatographic Methods: Checking the Peak Purity and the Specificity of Methods with Diode Array Detectors (Review) by N. A. Epshtein

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Transfer of Impurities Determination Methods: Comparative Testing, Validation, Acceptance Criteria (Review) by N. A. Epshtein

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Validation of Analytical Procedures: Graphic and Calculated Criteria for Assessment of Methods Linearity in Practice by N. A. Epshtein

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CHROMATOGRAPHIC SYSTEM SUITABILITY TESTING: INFLUENCE OF CORRECTION FACTORS AND LATE ELUTING PEAKS OF IMPURITIES ON THE REQUIREMENT FOR THE SIGNAL-TO-NOISE RATIO (REVIEW) by N. A. Epshtein

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VALIDATION OF CHROMATOGRAPHIC METHODS: ROBUSTNESS INVESTIGATION WITH USE OF EXPERIMENTAL DESIGN by N. A. Epshtein

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ABOUT STRESS EXPERIMENTS BY DEVELOPING / IMPROVING ANALYTICAL METHODS AND TECHNOLOGY OF DRUG SUBSTANCES AND MEDICINES by N. A. Epshtein

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RECOMMENDATIONS OF THE EUROPEAN PHARMACOPOEIA «ADJUSTMENT OF CHROMATOGRAPHIC CONDITIONS» AND THEIR RESTRICTIONS FOR THE METHODS OF IMPURITIES DETERMINATION by N. A. Epshtein, V. L. Sevastianova, A. I. Koroleva

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INVESTIGATION OF ROBUSTNESS AT VALIDATION OF HPLC AND UPLC METHODS: A MODERN APPROACH INCLUDING RISK ANALYSIS by N. A. Epshtein, V. L. Sevastianova, A. I. Koroleva

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