The book ‘Advanced Biopharmaceutics and Pharmacokinetics – the formulation approach is concerned with several aspects related to the fate of drug in the body.

   The book consists of 15 chapters, namely Introduction to Advanced Biopharmaceutics and Pharmacokinetics; Drug Absorption in GIT – Drug Considerations; Biopharmaceutics Considerations – Drug Products; Pharmacokinetics – One Compartment Modeling; Pharmacokinetics– Multicompartment Modeling; Physiology Based Pharmacokinetics; Non-linear Pharmacokinetics; Non-Compartment Modeling – Pharmacokinetics; Bioavailability – Drug Product Performance;etc.

   Special emphasis is given to include the following:
     1. Conceptualisation of principles,
     2. Applications of principles,
     3. A number of illustrations,
     4. Question bank.

1. INTRODUCTION TO ADVANCED BIOPHARMACEUTICS AND PHARMACOKINETICS
    
2. DRUG ABSORPTION FROM GIT - DRUG RELATED CONSIDERATIONS
     ƒ Mechanisms of Drug Absorption in GIT
     ƒ Properties of GIT Affecting Drug Absorption
     ƒ Metabolic Factors Influencing Drug Absorption
     ƒ Physicochemical Factors Influencing Drug Absorption
     ƒ Drug Dissolution Process – Factors influencing
     ƒ Dietary Components Influencing Drug Absorption
     ƒ Permeability-Solubility – Charge State Transport Model
     ƒ Experimental Transport Models – Drug Absorption
    
3. BIOPHARMACEUTICS CONSIDERATIONS - DRUG PRODUCTS DESIGN
     ƒ Physiological Factors of GIT – Dosage Form Design
     ƒ Rate-Limiting Steps in Oral Drug Absorption
     ƒ Compendial Methods of Dissolution
     ƒ Alternatives Models to Dissolution Testing
     ƒ Meeting Dissolution Requirements – Problems of Variable Control
     ƒ In Vitro Bioavailability Studies (Dissolution)
     ƒ Drug Release studies – Modeling for Analysis and Comparison
     ƒ In Vitro – In Vivo Correlations (IVIVC)
     ƒ Drug Release Profiles – Comparison
     ƒ Drug Stability Considerations – Design of Drug Product
     ƒ Formulation Design (Excipients) – Drug Product Performance
     ƒ Impact of Manufacturing Design on the Oral Drug Absorption
     ƒ Role of Dosage Forms Design on GIT Absorption

4. PHARMACOKINETICS - COMPARTMENT MODEL
     ƒ Intravenous Bolus Injection – One Compartment Open Model
     ƒ Intravenous Infusion – One Compartment Open Model
     ƒ Intravenous Bolus Injection – Multiple Dosing
     ƒ First Order Absorption Kinetics – One Com-partment Model
     ƒ Oral Dosage Regimen – Multiple Dosing
    
5. PHARMACOKINETICS - MULTICOMPARTMENT MODELS
     ƒ Two Compartment Open Model – IV Bolus Injection
     ƒ Apparent Volume of Distribution – Two Compartment Model
     ƒ Infusion – Two Compartment Open Model
     ƒ Drug Absorption Kinetics – Two Compartment Model
     ƒ Loo-Reigelman Method – Absorption Rate Constant
     ƒ Three Compartment Open Model – IV Bolus Injection
    
6. PHYSIOLOGY BASED PHARMACOKINETICS MODELING
     ƒ Blood Flow-Limited physiology Based PK Modeling
     ƒ Diffusion-Limited physiology Based PK Modeling
     ƒ Drug Binding-Limited Physiology Based PK Modeling
    
7. NON-LINEAR PHARMACOKINETICS
     ƒ Saturable Enzymatic Elimination – Michaelis-Menten Kinetics
     ƒ Drug Elimination – Capacity Limited Pharmacokinetics
     ƒ Determination of Km and Vm – Methods
     ƒ Chronopharmacokinetics
    
8. NON-COMPARTMENT MODELING - PHARMACOKINETICS
     ƒ Statistical Moment Theory and Categorisation of Moments
     ƒ Non-compartment Models – Pharmacokinetic Parameters
    
9. BIOAVAVILABILITY - DRUG PRODUCT PERFORMANCE
     ƒ Basic Principles
     ƒ Extent of Bioavailability
     ƒ Rate of Bioavailability
     ƒ Assessing Bioavailability – Methods
     ƒ Multiple Dosing – Bioavailability
    
10. BIOEQUIVALENCE - DOSAGE FROM EVALUATION
     ƒ General Principles
     ƒ Bioequivalence Studies – Methodology and Protocol
     ƒ PK Parameters – Logarithmic Transformations
     ƒ Statistical Analysis
     ƒ Generic Substitution
     ƒ Generic Product Submissions and Review
     ƒ Drug Products – Self-Evident BA or BE
     ƒ Special Concern about Bioequivalence Studies
     ƒ Biopharmaceutics Classification System (BCS)
     ƒ Bioequivalence – Generic Semisolid Products – TCS System
     ƒ Biopharmaceutics Drug Disposition Classification System (BDDCS)
     ƒ Biowaiver – In Vivo Bioequivalence
     ƒ Dissolution Comparison
     ƒ Clinical Significance – Bioequivalence
     ƒ Biologics and Biosimilars – Bioequivalence
    
11. DRUG - COMPONENT AND DRUG-DRUG INTERACTIONS
     ƒ In Vitro Biopharmaceutics Interactions
     ƒ Absorption Process – Drug Interactions
     ƒ Distribution Process – Drug-Protein Binding Interactions
     ƒ Distribution Process – Drug-Tissue Binding Interactions
     ƒ Biotransformation Process – Drug-Enzyme Interactions
     ƒ Drug Interactions Linked to CYP450 and Transporters
     ƒ Renal Excretion – Drug Interactions
     ƒ Pharmacodynamic Interactions
    
12. PHARMACODYNAMICS - PHARMACOKINETICS RELATIONSHIPS
     ƒ Dose – Drug Activity Relationship
     ƒ PK Parameters and Duration of Drug Activity
     ƒ Pharmacodynamics Modeling
     ƒ PK-PD Modeling
    
13. CONTROLLED DRUG DELIVERY SYSTEMS
     ƒ General Principles
     ƒ Selection of Drug for Controlled Drug Delivery Systems
     ƒ Design of Controlled Drug Delivery Systems
     ƒ Kinetics of Drug Release – CDDS
    
14. PHARMACOKINETICS OF BIOPHARMACEUTICALS
     ƒ Delivery and Targeting of Biopharmaceuticals
     ƒ Biopharmaceutics Considerations of Proteins and Peptides
     ƒ Biopharmaceutics Issues of Monoclonal Antibodies
     ƒ Biopharmaceutics Needs of Gene Therapeutics
     ƒ Biopharmaceutics Necessities of Oligonucleotides
     ƒ Pharmacokinetics of Biopharmaceuticals
     ƒ Pharmacokinetics of Biopharmaceuticals
    
15. DOSES - FIXING, ADJUSTMENT AND INDIVIDUALIZATION
     ƒ Determination of Dose
     ƒ Dose Adjustment in Certain Groups
     ƒ Design of Dosage Regimen
     ƒ Hepatic Disease – Dose Adjustment
     ƒ Renal Disease – Dose Adjustment
     ƒ Individualisation of Therapy
     ƒ Therapeutic Drug Monitoring
     ƒ Population Pharmacokinetics
    
     Appendix I   : Key to Numerical Problems
     Appendix II  : Glossary of Symbols
     Appendix III : Definitions and Meanings
     Appendix IV : Bibliography