BIOMEDICAL CHROMATOGRAPHY -- BIOMEDICAL CHROMATOGRAPHY -- CONTENTS -- PREFACE -- Chapter 1 BIOANALYSIS IN DRUG DISCOVERY AND DEVELOPMENT: FOCUS ON PHARMACOKINETIC STUDIES -- ABSTRACT -- INTRODUCTION -- OVERVIEW OF THE DRUG DISCOVERY AND DEVELOPMENT PROCESS -- BIOANALYSIS IN DRUG DISCOVERY AND DEVELOPMENT -- CHANGES IN BIOANALYTICAL METHODS DURING DRUG DISCOVERY AND DEVELOPMENT -- BIOANALYTICAL METHOD VALIDATION: FROM A REGULATORY PERSPECTIVE -- CONCLUSION -- ABBREVIATIONS -- REFERENCES -- Chapter 2 CHARACTERIZATION OF DRUG-PLASMATIC PROTEIN INTERACTIONS BY MICROSEPARATION TECHNIQUES -- ABSTRACT -- 1. INTRODUCTION -- 2. BINDING OF DRUGS TO PLASMATIC PROTEINS -- 3. METHODS TO EVALUATE DRUG-PLASMATIC PROTEINS INTERACTIONS -- 3.1. Chromatographic Techniques -- 3.2. Electrophoretic Techniques -- 4. IMPROVEMENTS IN FRONTAL ANALYSIS-CE -- 4. APPLICATIONS OF FRONTAL ANALYSIS-CAPILLARY ELECTROPHORESIS TO THE EVALUATION OF DRUGS- PLASMATIC PROTEINS INTERACTIONS -- CONCLUSION -- ACKNOWLEDGMENTS -- REFERENCES -- Chapter 3 STATISTICAL APPROACHES FOR BIOEQUIVALENCE OF HIGHLY VARIABLE DRUGS AND DRUG PRODUCTS -- GENERAL BACKGROUND -- OBJECTIVE -- HIGHLY VARIABLE DRUGS AND DRUG PRODUCTS -- Intra-Subject Variation -- Between-Subject Variation -- Within-Formulation Variation -- CONSIDERATIONS FOR BIOEQUIVALENCE TRIAL DESIGN -- ANALYSIS OF VARIANCE (ANOVA) FOR AVERAGE BIOEQUIVALENCE STUDIES -- SAMPLE SIZE DETERMINATION -- INTER- AND INTRA-SUBJECT VARIABILITIES -- ANALYSIS OF VARIANCE FOR REPEATED MEASUREMENTS -- INDIVIDUAL BIOEQUIVALENCE (IBE) -- SAMPLE SIZE FOR HIGHER-ORDER DESIGNS -- DISCUSSION AND CONCLUSIONS -- FUTURE PERSPECTIVES -- REFERENCES -- Chapter 4 NEW STRATEGIES OF SAMPLE PREPARATION IN THE ANALYSIS OF PHARMACEUTICALS AND THEIR DETERMINATION USING HIGH PERFORMANCE LIQUID CHROMATOGRAPHY -- ABSTRACT -- 1. INTRODUCTION.

2. SAMPLE PRE-CONCENTRATION PROCEDURES FOR WATER SAMPLES -- 2.1. Solid Phase Extraction -- 2.2. Solid Phase Microextraction -- 3. SAMPLE PRECONCENTRATION PROCEDURES FOR SOLID SAMPLES -- 3.1. Ultrasonic Extraction (USE) -- 3.2. Pressurized Liquid Extraction (PLE) -- 3.3. Microwave Assisted Extraction (MAE) -- CONCLUSIONS AND TRENDS -- ACKNOWLEDGMENTS -- REFERENCES -- Chapter 5 ANALYSIS OF CATECHOLAMINES WITH PEROXYOXALATE CHEMILUMINESCENCE REACTION DETECTION -- ABSTRACT -- 1. INTRODUCTION -- 2. ANALYTICAL METHODS FOR CATECHOLAMINES WITH HPLC-POCL DETECTION [10] -- 2.1. High Selectivity of the Method -- 2.2. Procedures of the Method -- 2.3. Chromatogram of Standard Catecholamines and Validation of the Method -- 2.4. Concentration of Catecholamines in Human and Rat Plasma -- 3. ANALYTICAL METHODS FOR CATECHOLAMINES AND THEIR 3-O-METHYL METABOLITES [17] -- 3.1. Coulometric Oxidation -- 3.2. Validation of the Method and Application to Rat Plasma -- Calibration curve, accuracy, and precision of the method -- Determination of catecholamines and their 3-O-methyl metabolites in rat plasma -- 4. APPLICATION OF THESE METHODS TO BIO-SAMPLES FOR THE CLARIFICATION OF THE ROLE OF CATECHOLAMINES METABOLISM IN BLOOD PRESSURE REGULATION -- 5. CONCLUSION -- REFERENCES -- Chapter 6 PHOTOPRODUCTS OF NAPROXEN IN ALCOHOLIC SOLVENTS -- ABSTRACT -- INTRODUCTION -- EXPERIMENTAL -- General Methods and Materials -- HPLC Apparatus and Assay Conditions -- Photochemical Reactor and Irradiation Conditions -- Various Spectrometers -- Sample Preparation and Photodegradation of Naproxen -- Characterization of Naproxen and Its Photoproducts by Spectroscopic Methods -- Naproxen (NAP), 6-methoxy-α-methyl-2-naphthaleneacetic acid -- 6-Methoxy-α-methyl-2-naphthalenemethanol (1) -- 2-Acetyl-6-methoxynaphthalene (2) -- 2-Ethyl-6-methoxynaphthalene (3).

2-(6-Methoxy-2-naphthalenyl)propionic acid, methyl ester (4) -- 2-(6-Methoxy-2-naphthalenyl)propionic acid, ethyl ester (5) -- RESULTS AND DISCUSSION -- HPLC Separation of the Photoproducts of Naproxen -- Structural Characterization of the Photoproducts -- A Proposed Reaction Scheme for Naproxen -- CONCLUSION -- ACKNOWLEDGMENT -- REFERENCES -- INDEX -- Blank Page.