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About The Book
The book involves the quantification of drug in different processes, such as absorption, distribution, biotransformation and excretion. Several these aspects are important in the clinical situations. This is a basic level book which is normally important for third/final year of B. Pharm. course. These topics are so important that at PG level also these are included. The students of IV year, Bachelor of Pharmacy have been expressing the need for a simple book. This book will help learning calculating the pharmacokinetics parameters.
The book is broadly divided into Biopharmaceutics part and Pharmacokinetics part. Special emphasis is given to include the following:
1. Conceptualisation of principles.
2. Applications of principles.
3. A number of illustrations.
4. Question bank.
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Chapter 1. Introduction to Biopharmaceutics
Fate of Drug in the Body
Experimental Studies—Models
Question Bank
Chapter 2. Drug Level-time Curves and Therapeutic Activity
Blood Drug Level-Time Analysis
Blood Drug Level-Time Curves—Routes of Administration
Blood Drug Level -Time Curves—Therapeutic Activity
Urinary Drug Level-Time Analysis
Urinary Drug Level-Time Curves
Salivary Drug Level-Time Analysis
Drug Concentration in Feces
Question Bank
Chapter 3. Drug Dissolution
Dissolution—Drug Absorption
Dissolution—Tablets and Capsules
Mathematical Treatment - Dissolution
Theories of Dissolution
Factors Influencing Dissolution
Dissolution Test Apparatus
Question Bank
Chapter 4. Drug Absorption—Factors Influencing
Gastrointestinal Tract—Physiology
Mechanisms of Drug Absorption in Gastrointestinal Tract
Biological Factors Influencing Drug Absorption
Metabolic Factors Influencing Drug Absorption
Physicochemical Factors Influencing Drug Absorption
Dietary Components Influencing Drug Absorption
Drug Absorption—Experimental Models
Formulation Related Factors Affecting Drug Absorption
Role of Dosage Forms on Drug Absorption
Role of Manufacturing/Processing Variables on Drug Absorption
Absorption of Drugs from Non-oral Extravascular Routes
Question Bank
Chapter 5. Dosage Form Evaluation—Bioavailability
General Principles
Extent of Bioavailability
Rate of Bioavailability
Assessing Bioavailability—Methods
Multiple Dosing—Bioavailability
In Vitro Bioavailability Studies (Dissolution)
In Vitro—In Vivo Correlations (IVIVC)
Biopharmaceutical Classification System
Question Bank
Chapter 6. Dosage Form Evaluation—Bioequivalence
General Principles
Bioequivalence Requirement—Criteria
Bioequivalence Requirement—Criteria for Waiver
Pharmacokinetic Parameters—Logarithmic Transformations
Bioequivalence Studies—Methodology
Statistical Analysis
Question Bank
Chapter 7. Drug-Drug Interactions
Multi-drug Therapy—Importance
In vitro Bio-Pharmaceutical Interactions
Pharmacokinetic Interactions
Pharmacodynamic Interactions
Question Bank
Chapter 8. Controlled Drug Delivery Systems
General Principles
Selection of Drug for Controlled Drug Delivery Systems
Design of Controlled Drug Delivery System
Kinetics of Drug Release—Controlled Drug Delivery Systems
Question Bank
Chapter 9. Introduction to Pharmacokinetics
Pharmacokinetic Models
Compartment Models
Physiological Models
Question Bank
Chapter 10. Pharmacokinetic Models—Drug Disposition
One Compartment Open Model—Drug Disposition
Plasma Elimination Half Life—One-Compartment Open Model
Multi exponential Decay—Drug Disposition
Two-Compartment Open Model—Drug Disposition
Three-Compartment Open Model—Drug Disposition
Question Bank
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Chapter 11. Drug Distribution in the Body
Apparent Volume of Distribution—One-Compartment Open Model
Apparent Volume of Distribution—Two-Compartment Open Mode
Real Volume of Distribution
Factors Influencing Drug Distribution
Question Bank
Chapter 12. Protein Binding of Drugs
Implications of Drug—Protein Binding
Blood Proteins—Characteristics
Factors Affecting Drug—Protein Binding
Kinetics of Drug-Protein Binding
Drug-Protein Binding—Experimental Methods
Protein Binding—Diseased State
Question Bank
Chapter 13. Biotransformation of Drugs
Metabolizing Organs, Enzymes and Reactions
Pathways of Drug Biotransformation
Phase I Biotransformation Reactions
Phase II Biotransformation Reactions
Factors Affecting Biotransformation of Drugs
Pharmacokinetics of Drug Metabolism
First-Pass Effect
Question Bank
Chapter 14. Excretion of Drugs
Renal Excretion of Drugs
Mechanisms of Renal Excretion of Drugs
Factors Influencing Renal Excretion of Drugs
Non-renal Routes of Drug Excretion
Question Bank
Chapter 15. Drug Elimination - Clearance Concepts
Clearance
Renal Clearance
Hepatic Clearance
Organ Clearance
Biliary Clearance
Question Bank
Chapter 16. Pharmacokinetics of Drug Absorption
Zero Order absorption kinetics
First Order absorption kinetics—One Compartment Open Model
Wagner-Nelson Method—Determination of ka
Urine Data—Determination of Parameters
Two Compartment Open Model—Loo-Reigelman Method
Variations in Plasma Drug-Time Curves—Oral Administration
Question Bank
Chapter 17. Constant Rate Infusion—Pharmacokinetics
Infusion—One Compartment Open Model
Infusion—Two Compartment Open Model
Infusion Plus Loading Dose—One Compartment Open Model
Infusion Plus Loading Dose—Two Compartment Open Model
Question Bank
Chapter 18. Multiple Dosage Regimen
Drug Accumulation—Multiple Dosing
Intravenous Injection—Multiple Dosing
Oral Dosage Regimen—Multiple Dosing
Loading Dose and Multiple i.v. Dosing
Loading Dose and Multiple Oral Dosing
Scheduling of Dosage Regimen
Question Bank
Chapter 19. Nonlinear Pharmacokinetics
Saturable Enzymatic Elimination—Michaelis-Menten Kinetics
Drug Elimination—Capacity Limited Pharmacokinetics
Determination of Km and Vm—Methods
Chronopharmacokinetics
Question bank
Chapter 20. Doses—Fixing, Adjustment and Individualization
Determination of Dose
Dose Adjustment in Certain Groups
Design of Dosage Regimen
Hepatic Disease—Dose Adjustment
Renal Disease—Dose Adjustment
Individualisation of Therapy
Therapeutic Drug Monitoring
Population Pharmacokinetics
Question Bank
Chapter 21. Non-Compartment Models—Pharmacokinetics
Statistical Moment Theory and Categorisation of Moments
Noncompartment Models—Pharmacokinetic Parameters
Question Bank
Appendix-I : Definitions and Meanings
Appendix-II : All in Twos—Know Them Well
Appendix-III : Bibliography
Appendix-IV : Answers to Numerical Problems
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