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Title Applied biopharmaceutics & pharmacokinetics Author Leon Shargel; Andrew B. C. Yu; Andrew B.

Applied biopharmaceutics and pharmacokinetics 5th edition pdf free download.

Title Applied biopharmaceutics & pharmacokinetics Author Leon Shargel; Andrew B. C. wune Yu; Andrew B. C. Yu (editor); Leon Shargel (editor) Language English ISBN 9780071830935 / 0071830936 / 9789814670241 / 9814670243 Year 2016 File Size 15.5 MB Total Downloads 5,017 Total Views 19,492 Edition Seventh Pages In File 929 Identifier
9780071830935,0071830936,9789814670241,9814670243 Org File Size 16,218,926 Extension pdf Download Applied biopharmaceutics & pharmacokinetics PDF Cover Title Page Copyright Page Contents Contributors Preface Preface to First Edition 1. Introduction to Biopharmaceutics and Pharmacokinetics Drug Product Performance
Biopharmaceutics Pharmacokinetics Pharmacodynamics Clinical Pharmacokinetics Practical Focus Pharmacodynamics Drug Exposure and Drug Response Toxicokinetics and Clinical Toxicology Measurement of Drug Concentrations Basic Pharmacokinetics and Pharmacokinetic Models Chapter Summary Learning Questions Answers References
Bibliography 2. Mathematical Fundamentals in Pharmacokinetics Calculus Graphs Practice Problem Mathematical Expressions and Units Units for Expressing Blood Concentrations Measurement and Use of Significant Figures Practice Problem Practice Problem Rates and Orders of Processes Chapter Summary Learning Questions Answers
References 3. Biostatistics Variables Types of Data (Nonparametric Versus Parametric) Distributions Measures of Central Tendency Measures of Variability Hypothesis Testing Statistically Versus Clinically Significant Differences Statistical Inference Techniques in Hypothesis Testing for Parametric Data Goodness of Fit Statistical Inference
Techniques for Hypothesis Testing With Nonparametric Data Controlled Versus Noncontrolled Studies Blinding Confounding Validity Bioequivalence Studies Evaluation of Risk for Clinical Studies Chapter Summary Learning Questions Answers References 4. One-Compartment Open Model: Intravenous Bolus Administration Elimination Rate Constant
Apparent Volume of Distribution Clearance Clinical Application Calculation of k From Urinary Excretion Data Practice Problem Practice Problem Clinical Application Chapter Summary Learning Questions Answers Reference Bibliography 5. Multicompartment Models: Intravenous Bolus Administration Two-Compartment Open Model Clinical
Application Practice Problem Practical Focus Practice Problem Practical Focus Three-Compartment Open Model Clinical Application Clinical Application Determination of Compartment Models Practical Focus Clinical Application Practical Problem Clinical Application Practical Application Clinical Application Chapter Summary Learning Questions
Answers References Bibliography 6. wiweyuyiyejugu Intravenous Infusion One-Compartment Model Drugs Infusion Method for Calculating Patient Elimination Half-Life Loading Dose Plus IV Infusion—One-Compartment Model Practice Problems Estimation of Drug Clearance and V[sub(D)] From Infusion Data Intravenous Infusion of Two-
Compartment Model Drugs Practical Focus Chapter Summary Learning Questions Answers Reference Bibliography 7. Drug Elimination, Clearance, and Renal Clearance Drug Elimination Drug Clearance Clearance Models The Kidney Clinical Application Practice Problems Renal Clearance Determination of Renal Clearance Practice Problem Practice
Problem Relationship of Clearance to Elimination Half-Life and Volume of Distribution Chapter Summary Learning Questions Answers References Bibliography 8. Pharmacokinetics of Oral Absorption Introduction Basic Principles of Physiologically Based Absorption Kinetics (Bottom-Up Approach) Absoroption Kinetics (The Top-Down Approach)
Pharmacokinetics of Drug Absorption Significance of Absorption Rate Constants Zero-Order Absorption Model Clinical Application—Transdermal Drug Delivery First-Order Absorption Model Practice Problem Chapter Summary Answers Application Questions References Bibliography 9. Multiple-Dosage Regimens Drug Accumulation Clinical Example
Repetitive Intravenous Injections Intermittent Intravenous Infusion Clinical Example Estimation of k and V[sub(D)] of Aminoglycosides in Clinical Situations Multiple-Oral-Dose Regimen Loading Dose Dosage Regimen Schedules Clinical Example Practice Problems Chapter Summary Learning Questions Answers References Bibliography 10. Nonlinear
Pharmacokinetics Saturable Enzymatic Elimination Processes Practice Problem Practice Problem Drug Elimination by Capacity-Limited Pharmacokinetics: One-Compartment Model, IV Bolus Injection Practice Problems Clinical Focus Clinical Focus Drugs Distributed as One-Compartment Model and Eliminated by Nonlinear Pharmacokinetics Clinical
Focus Chronopharmacokinetics and Time-Dependent Pharmacokinetics Clinical Focus Bioavailability of Drugs That Follow Nonlinear Pharmacokinetics Nonlinear Pharmacokinetics Due to Drug–Protein Binding Potential Reasons for Unsuspected Nonlinearity Dose-Dependent Pharmacokinetics Clinical Example Chapter Summary Learning Questions
Answers References Bibliography 11. Physiologic Drug Distribution and Protein Binding Physiologic Factors of Distribution Clinical Focus Apparent Volume Distribution Practice Problem Protein Binding of Drugs Clinical Examples Effect of Protein Binding on the Apparent Volume of Distribution Practice Problem Clinical Example Relationship of
Plasma Drug–Protein Binding to Distribution and Elimination Clinical Examples Clinical Example Determinants of Protein Binding Clinical Example Kinetics of Protein Binding Practical Focus Determination of Binding Constants and Binding Sites by Graphic Methods Clinical Significance of Drug–Protein Binding Clinical Example Clinical Example
Modeling Drug Distribution Chapter Summary Learning Questions Answers References Bibliography 12. Drug Elimination and Hepatic Clearance Route of Drug Administration and Extrahepatic Drug Metabolism Practical Focus Hepatic Clearance Extrahepatic Metabolism Enzyme Kinetics—Michaelis–Menten Equation Clinical Example Practice
Problem Anatomy and Physiology of the Liver Hepatic Enzymes Involved in the Biotransformation of Drugs Drug Biotransformation Reactions Pathways of Drug Biotransformation Drug Interaction Example Clinical Example First-Pass Effects Hepatic Clearance of a Protein-Bound Drug: Restrictive and Nonrestrictive Clearance From Binding Biliary
Excretion of Drugs Clinical Example Role of Transporters on Hepatic Clearance and Bioavailability Chapter Summary Learning Questions Answers References Bibliography 13. Pharmacogenetics and Drug Metabolism Genetic Polymorphisms Cytochrome P-450 Isozymes Phase II Enzymes Transporters Chapter Summary Glossary Abbreviations
References 14. Physiologic Factors Related to Drug Absorption Drug Absorption and Design of a Drug Product Route of Drug Administration Nature of Cell Membranes Passage of Drugs Across Cell Membranes Drug Interactions in the Gastrointestinal Tract Oral Drug Absorption Oral Drug Absorption During Drug Product Development Methods for
Studying Factors That Affect Drug Absorption Effect of Disease States on Drug Absorption Miscellaneous Routes of Drug Administration Chapter Summary Learning Questions Answers to Questions References Bibliography 15. Biopharmaceutic Considerations in Drug Product Design and In Vitro Drug Product Performance Biopharmaceutic Factors
and Rationale for Drug Product Design Rate-Limiting Steps in Drug Absorption Physicochemical Properties of the Drug Formulation Factors Affecting Drug Product Performance Drug Product Performance, In Vitro: Dissolution and Drug Release Testing Compendial Methods of Dissolution Alternative Methods of Dissolution Testing Dissolution Profile
Comparisons Meeting Dissolution Requirements Problems of Variable Control in Dissolution Testing Performance of Drug Products: In Vitro–In Vivo Correlation Approaches to Establish Clinically Relevant Drug Product Specifications Drug Product Stability Considerations in the Design of a Drug Product Drug Product Considerations Clinical Example
Chapter Summary Learning Questions Answers References Bibliography 16. Drug Product Performance, In Vivo: Bioavailability and Bioequivalence Drug Product Performance Purpose of Bioavailability and Bioequivalence Studies Relative and Absolute Availability Practice Problem Methods for Assessing Bioavailability and Bioequivalence In Vivo
Measurement of Active Moiety or Moieties in Biological Fluids Bioequivalence Studies Based on Pharmacodynamic Endpoints—In Vivo Pharmacodynamic (PD) Comparison Bioequivalence Studies Based on Clinical Endpoints—Clinical Endpoint Study In Vitro Studies Other Approaches Deemed Acceptable (by the FDA) Bioequivalence Studies Based on
Multiple Endpoints Bioequivalence Studies Design and Evaluation of Bioequivalence Studies Study Designs Crossover Study Designs Clinical Example Clinical Example Pharmacokinetic Evaluation of the Data The Partial AUC in Bioequivalence Analysis Examples of Partial AUC Analyses Bioequivalence Examples Study Submission and Drug Review
Process Waivers of In Vivo Bioequivalence Studies (Biowaivers) The Biopharmaceutics Classification System (BCS) Generic Biologics (Biosimilar Drug Products) Clinical Significance of Bioequivalence Studies Special Concerns in Bioavailability and Bioequivalence Studies Generic Substitution Glossary Chapter Summary Learning Questions Answers
References 17. Biopharmaceutical Aspects of the Active Pharmaceutical Ingredient and Pharmaceutical Equivalence Introduction Pharmaceutical Alternatives Practice Problem Bioequivalence of Drugs With Multiple Indications Formulation and Manufacturing Process Changes Size, Shape, and Other Physical Attributes of Generic Tablets and
Capsules Changes to an Approved NDA or ANDA The Future of Pharmaceutical Equivalence and Therapeutic Equivalence Biosimilar Drug Products Historical Perspective Chapter Summary Learning Questions Answers References 18. Impact of Biopharmaceutics on Drug Product Quality and Clinical Efficacy Risks From Medicines Risk Assessment
Drug Product Quality and Drug Product Performance Pharmaceutical Development Example of Quality Risk Excipient Effect on Drug Product Performance Practical Focus Quality Control and Quality Assurance Practical Focus Risk Management Scale-Up and Postapproval Changes (SUPAC) Practical Focus Product Quality Problems Postmarketing
Surveillance Glossary Chapter Summary Learning Questions Answers References Bibliography 19.
Modified-Release Drug Products and Drug Devices Modified-Release (MR) Drug Products and Conventional (Immediate-Release, IR) Drug Products Biopharmaceutic Factors Dosage Form Selection Advantages and Disadvantages of Extended-Release Products Kinetics of Extended-Release Dosage Forms Pharmacokinetic Simulation of Extended-
Release Products Clinical Examples Types of Extended-Release Products Considerations in the Evaluation of Modified-Release Products Evaluation of Modified-Release Products Evaluation of In Vivo Bioavailability Data Chapter Summary Learning Questions References Bibliography 20. Targeted Drug Delivery Systems and Biotechnological Products
Biotechnology Drug Carriers and Targeting Targeted Drug Delivery Pharmacokinetics of Biopharmaceuticals Bioequivalence of Biotechnology-Derived Drug Products Learning Questions Answers References Bibliography 21. Relationship Between Pharmacokinetics and Pharmacodynamics Pharmacokinetics and Pharmacodynamics Relationship of
Dose to Pharmacologic Effect Relationship Between Dose and Duration of Activity (t[sub(eff)]), Single IV Bolus Injection Practice Problem Effect of Both Dose and Elimination Half-Life on the Duration of Activity Effect of Elimination Half-Life on Duration of Activity Substance Abuse Potential Drug Tolerance and Physical Dependency Hypersensitivity
and Adverse Response Chapter Summary Learning Questions Answers References 22. Application of Pharmacokinetics to Clinical Situations Medication Therapy Management Individualization of Drug Dosage Regimens Therapeutic Drug Monitoring Clinical Example Clinical Example Design of Dosage Regimens Conversion From Intravenous Infusion
to Oral Dosing Determination of Dose Practice Problems Effect of Changing Dose ond Dosing Interval on C[sub(max)][sup(∞)], C[sub(min)][sup(∞)], and C[sub(av)][sup(∞) Determination of Frequency of Drug Administration Determination of Both Dose and Dosage Interval Practice Problem Determination of Route of Administration Dosing Infants and
Children Practice Problem Dosing the Elderly Practice Problems Clinical Example Dosing the Obese Patients Pharmacokinetics of Drug Interactions Inhibition of Drug Metabolism Inhibition of Monoamine Oxidase (MAO) Induction of Drug Metabolism Inhibition of Drug Absorption Inhibition of Biliary Excretion Altered Renal Reabsorption Due to
Changing Urinary pH Practical Focus Effect of Food on Drug Disposition Adverse Viral Drug Interactions Population Pharmacokinetics Clinical Example Regional Pharmacokinetics Chapter Summary Learning Questions Answers References Bibliography 23. Application of Pharmacokinetics to Specific Populations: Geriatric, Obese, and Pediatric
Patients Specific and Special Populations Module I: Application of Pharmacokinetics to the Geriatric Patients Summary Learning Questions Answers References Further Reading Module II: Application of Pharmacokinetics to the Obese Patients Summary Learning Questions Answers References Module III: Application of Pharmacokinetics to the
Pediatric Patients Summary Learning Questions Answers References 24. Dose Adjustment in Renal and Hepatic Disease Renal Impairment Pharmacokinetic Considerations General Approaches for Dose Adjustment in Renal Disease Measurement of Glomerular Filtration Rate Serum Creatinine Concentration and Creatinine Clearance Practice
Problems Dose Adjustment for Uremic Patients Practice Problem Practice Problem Practice Problems Practice Problem Extracorporeal Removal of Drugs Practice Problem Clinical Examples Effect of Hepatic Disease on Pharmacokinetics Practice Problem Chapter Summary Learning Questions Answers References Bibliography 25. Empirical Models,
Mechanistic Models, Statistical Moments, and Noncompartmental Analysis Empirical Models Mechanistic Models Noncompartmental Analysis Comparison of Different Approaches Selection of Pharmacokinetic Models Chapter Summary Learning Questions Answers References Bibliography Appendix A: Applications of Software Packages in
Pharmacokinetics Appendix B: Glossary Index A B C D E F G H I J K L M N O P Q R S T U V W X Z Pharmacokinetics is the subject that deals with the rates of movement of a drug and/or its metabolite(s) in the body and forces acting on the process.

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Title Applied biopharmaceutics & pharmacokinetics Author Leon Shargel; Andrew B. C. Yu; Andrew B. C. Yu (editor); Leon Shargel (editor) Language English ISBN 9780071830935 / 0071830936 / 9789814670241 / 9814670243 Year 2016 File Size 15.5 MB Total Downloads 5,017 Total Views 19,492 Edition Seventh Pages In File 929 Identifier
9780071830935,0071830936,9789814670241,9814670243 Org File Size 16,218,926 Extension pdf Download Applied biopharmaceutics & pharmacokinetics PDF Cover Title Page Copyright Page Contents Contributors Preface Preface to First Edition 1. Introduction to Biopharmaceutics and Pharmacokinetics Drug Product Performance
Biopharmaceutics Pharmacokinetics Pharmacodynamics Clinical Pharmacokinetics Practical Focus Pharmacodynamics Drug Exposure and Drug Response Toxicokinetics and Clinical Toxicology Measurement of Drug Concentrations Basic Pharmacokinetics and Pharmacokinetic Models Chapter Summary Learning Questions Answers References
Bibliography 2. Mathematical Fundamentals in Pharmacokinetics Calculus Graphs Practice Problem Mathematical Expressions and Units Units for Expressing Blood Concentrations Measurement and Use of Significant Figures Practice Problem Practice Problem Rates and Orders of Processes Chapter Summary Learning Questions Answers
References 3. Biostatistics Variables Types of Data (Nonparametric Versus Parametric) Distributions Measures of Central Tendency Measures of Variability Hypothesis Testing Statistically Versus Clinically Significant Differences Statistical Inference Techniques in Hypothesis Testing for Parametric Data Goodness of Fit Statistical Inference
Techniques for Hypothesis Testing With Nonparametric Data Controlled Versus Noncontrolled Studies Blinding Confounding Validity Bioequivalence Studies Evaluation of Risk for Clinical Studies Chapter Summary Learning Questions Answers References 4. One-Compartment Open Model: Intravenous Bolus Administration Elimination Rate Constant
Apparent Volume of Distribution Clearance Clinical Application Calculation of k From Urinary Excretion Data Practice Problem Practice Problem Clinical Application Chapter Summary Learning Questions Answers Reference Bibliography 5.
Applied biopharmaceutics and pharmacokinetics 5th edition pdf free download.

Title Applied biopharmaceutics & pharmacokinetics Author Leon Shargel; Andrew B. xabulite C.
Yu; Andrew B. C. Yu (editor); Leon Shargel (editor) Language English ISBN 9780071830935 / 0071830936 / 9789814670241 / 9814670243 Year 2016 File Size 15.5 MB Total Downloads 5,017 Total Views 19,492 Edition Seventh Pages In File 929 Identifier 9780071830935,0071830936,9789814670241,9814670243 Org File Size 16,218,926 Extension
pdf Download Applied biopharmaceutics & pharmacokinetics PDF Cover Title Page Copyright Page Contents Contributors Preface Preface to First Edition 1. Introduction to Biopharmaceutics and Pharmacokinetics Drug Product Performance Biopharmaceutics Pharmacokinetics Pharmacodynamics Clinical Pharmacokinetics Practical Focus
Pharmacodynamics Drug Exposure and Drug Response Toxicokinetics and Clinical Toxicology Measurement of Drug Concentrations Basic Pharmacokinetics and Pharmacokinetic Models Chapter Summary Learning Questions Answers References Bibliography 2. yohipesivu Mathematical Fundamentals in Pharmacokinetics Calculus Graphs Practice
Problem Mathematical Expressions and Units Units for Expressing Blood Concentrations Measurement and Use of Significant Figures Practice Problem Practice Problem Rates and Orders of Processes Chapter Summary Learning Questions Answers References 3. Biostatistics Variables Types of Data (Nonparametric Versus Parametric) Distributions
Measures of Central Tendency Measures of Variability Hypothesis Testing Statistically Versus Clinically Significant Differences Statistical Inference Techniques in Hypothesis Testing for Parametric Data Goodness of Fit Statistical Inference Techniques for Hypothesis Testing With Nonparametric Data Controlled Versus Noncontrolled Studies Blinding
Confounding Validity Bioequivalence Studies Evaluation of Risk for Clinical Studies Chapter Summary Learning Questions Answers References 4. One-Compartment Open Model: Intravenous Bolus Administration Elimination Rate Constant Apparent Volume of Distribution Clearance Clinical Application Calculation of k From Urinary Excretion Data
Practice Problem Practice Problem Clinical Application Chapter Summary Learning Questions Answers Reference Bibliography 5. Multicompartment Models: Intravenous Bolus Administration Two-Compartment Open Model Clinical Application Practice Problem Practical Focus Practice Problem Practical Focus Three-Compartment Open Model
Clinical Application Clinical Application Determination of Compartment Models Practical Focus Clinical Application Practical Problem Clinical Application Practical Application Clinical Application Chapter Summary Learning Questions Answers References Bibliography 6. Intravenous Infusion One-Compartment Model Drugs Infusion Method for
Calculating Patient Elimination Half-Life Loading Dose Plus IV Infusion—One-Compartment Model Practice Problems Estimation of Drug Clearance and V[sub(D)] From Infusion Data Intravenous Infusion of Two-Compartment Model Drugs Practical Focus Chapter Summary Learning Questions Answers Reference Bibliography 7. Drug Elimination,
Clearance, and Renal Clearance Drug Elimination Drug Clearance Clearance Models The Kidney Clinical Application Practice Problems Renal Clearance Determination of Renal Clearance Practice Problem Practice Problem Relationship of Clearance to Elimination Half-Life and Volume of Distribution Chapter Summary Learning Questions Answers
References Bibliography 8. habadivokavera Pharmacokinetics of Oral Absorption Introduction Basic Principles of Physiologically Based Absorption Kinetics (Bottom-Up Approach) Absoroption Kinetics (The Top-Down Approach) Pharmacokinetics of Drug Absorption Significance of Absorption Rate Constants Zero-Order Absorption Model Clinical
Application—Transdermal Drug Delivery First-Order Absorption Model Practice Problem Chapter Summary Answers Application Questions References Bibliography 9. Multiple-Dosage Regimens Drug Accumulation Clinical Example Repetitive Intravenous Injections Intermittent Intravenous Infusion Clinical Example Estimation of k and V[sub(D)] of
Aminoglycosides in Clinical Situations Multiple-Oral-Dose Regimen Loading Dose Dosage Regimen Schedules Clinical Example Practice Problems Chapter Summary Learning Questions Answers References Bibliography 10.
Nonlinear Pharmacokinetics Saturable Enzymatic Elimination Processes Practice Problem Practice Problem Drug Elimination by Capacity-Limited Pharmacokinetics: One-Compartment Model, IV Bolus Injection Practice Problems Clinical Focus Clinical Focus Drugs Distributed as One-Compartment Model and Eliminated by Nonlinear
Pharmacokinetics Clinical Focus Chronopharmacokinetics and Time-Dependent Pharmacokinetics Clinical Focus Bioavailability of Drugs That Follow Nonlinear Pharmacokinetics Nonlinear Pharmacokinetics Due to Drug–Protein Binding Potential Reasons for Unsuspected Nonlinearity Dose-Dependent Pharmacokinetics Clinical Example Chapter
Summary Learning Questions Answers References Bibliography 11.
Physiologic Drug Distribution and Protein Binding Physiologic Factors of Distribution Clinical Focus Apparent Volume Distribution Practice Problem Protein Binding of Drugs Clinical Examples Effect of Protein Binding on the Apparent Volume of Distribution Practice Problem Clinical Example Relationship of Plasma Drug–Protein Binding to
Distribution and Elimination Clinical Examples Clinical Example Determinants of Protein Binding Clinical Example Kinetics of Protein Binding Practical Focus Determination of Binding Constants and Binding Sites by Graphic Methods Clinical Significance of Drug–Protein Binding Clinical Example Clinical Example Modeling Drug Distribution Chapter
Summary Learning Questions Answers References Bibliography 12. Drug Elimination and Hepatic Clearance Route of Drug Administration and Extrahepatic Drug Metabolism Practical Focus Hepatic Clearance Extrahepatic Metabolism Enzyme Kinetics—Michaelis–Menten Equation Clinical Example Practice Problem Anatomy and Physiology of the
Liver Hepatic Enzymes Involved in the Biotransformation of Drugs Drug Biotransformation Reactions Pathways of Drug Biotransformation Drug Interaction Example Clinical Example First-Pass Effects Hepatic Clearance of a Protein-Bound Drug: Restrictive and Nonrestrictive Clearance From Binding Biliary Excretion of Drugs Clinical Example Role
of Transporters on Hepatic Clearance and Bioavailability Chapter Summary Learning Questions Answers References Bibliography 13. Pharmacogenetics and Drug Metabolism Genetic Polymorphisms Cytochrome P-450 Isozymes Phase II Enzymes Transporters Chapter Summary Glossary Abbreviations References 14. Physiologic Factors Related to
Drug Absorption Drug Absorption and Design of a Drug Product Route of Drug Administration Nature of Cell Membranes Passage of Drugs Across Cell Membranes Drug Interactions in the Gastrointestinal Tract Oral Drug Absorption Oral Drug Absorption During Drug Product Development Methods for Studying Factors That Affect Drug Absorption
Effect of Disease States on Drug Absorption Miscellaneous Routes of Drug Administration Chapter Summary Learning Questions Answers to Questions References Bibliography 15. Biopharmaceutic Considerations in Drug Product Design and In Vitro Drug Product Performance Biopharmaceutic Factors and Rationale for Drug Product Design Rate-
Limiting Steps in Drug Absorption Physicochemical Properties of the Drug Formulation Factors Affecting Drug Product Performance Drug Product Performance, In Vitro: Dissolution and Drug Release Testing Compendial Methods of Dissolution Alternative Methods of Dissolution Testing Dissolution Profile Comparisons Meeting Dissolution
Requirements Problems of Variable Control in Dissolution Testing Performance of Drug Products: In Vitro–In Vivo Correlation Approaches to Establish Clinically Relevant Drug Product Specifications Drug Product Stability Considerations in the Design of a Drug Product Drug Product Considerations Clinical Example Chapter Summary Learning
Questions Answers References Bibliography 16. Drug Product Performance, In Vivo: Bioavailability and Bioequivalence Drug Product Performance Purpose of Bioavailability and Bioequivalence Studies Relative and Absolute Availability Practice Problem Methods for Assessing Bioavailability and Bioequivalence In Vivo Measurement of Active Moiety
or Moieties in Biological Fluids Bioequivalence Studies Based on Pharmacodynamic Endpoints—In Vivo Pharmacodynamic (PD) Comparison Bioequivalence Studies Based on Clinical Endpoints—Clinical Endpoint Study In Vitro Studies Other Approaches Deemed Acceptable (by the FDA) Bioequivalence Studies Based on Multiple Endpoints
Bioequivalence Studies Design and Evaluation of Bioequivalence Studies Study Designs Crossover Study Designs Clinical Example Clinical Example Pharmacokinetic Evaluation of the Data The Partial AUC in Bioequivalence Analysis Examples of Partial AUC Analyses Bioequivalence Examples Study Submission and Drug Review Process Waivers of In
Vivo Bioequivalence Studies (Biowaivers) The Biopharmaceutics Classification System (BCS) Generic Biologics (Biosimilar Drug Products) Clinical Significance of Bioequivalence Studies Special Concerns in Bioavailability and Bioequivalence Studies Generic Substitution Glossary Chapter Summary Learning Questions Answers References 17.
Biopharmaceutical Aspects of the Active Pharmaceutical Ingredient and Pharmaceutical Equivalence Introduction Pharmaceutical Alternatives Practice Problem Bioequivalence of Drugs With Multiple Indications Formulation and Manufacturing Process Changes Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules Changes to
an Approved NDA or ANDA The Future of Pharmaceutical Equivalence and Therapeutic Equivalence Biosimilar Drug Products Historical Perspective Chapter Summary Learning Questions Answers References 18. Impact of Biopharmaceutics on Drug Product Quality and Clinical Efficacy Risks From Medicines Risk Assessment Drug Product Quality
and Drug Product Performance Pharmaceutical Development Example of Quality Risk Excipient Effect on Drug Product Performance Practical Focus Quality Control and Quality Assurance Practical Focus Risk Management Scale-Up and Postapproval Changes (SUPAC) Practical Focus Product Quality Problems Postmarketing Surveillance Glossary
Chapter Summary Learning Questions Answers References Bibliography 19. Modified-Release Drug Products and Drug Devices Modified-Release (MR) Drug Products and Conventional (Immediate-Release, IR) Drug Products Biopharmaceutic Factors Dosage Form Selection Advantages and Disadvantages of Extended-Release Products Kinetics of
Extended-Release Dosage Forms Pharmacokinetic Simulation of Extended-Release Products Clinical Examples Types of Extended-Release Products Considerations in the Evaluation of Modified-Release Products Evaluation of Modified-Release Products Evaluation of In Vivo Bioavailability Data Chapter Summary Learning Questions References
Bibliography 20. Targeted Drug Delivery Systems and Biotechnological Products Biotechnology Drug Carriers and Targeting Targeted Drug Delivery Pharmacokinetics of Biopharmaceuticals Bioequivalence of Biotechnology-Derived Drug Products Learning Questions Answers References Bibliography 21. Relationship Between Pharmacokinetics and
Pharmacodynamics Pharmacokinetics and Pharmacodynamics Relationship of Dose to Pharmacologic Effect Relationship Between Dose and Duration of Activity (t[sub(eff)]), Single IV Bolus Injection Practice Problem Effect of Both Dose and Elimination Half-Life on the Duration of Activity Effect of Elimination Half-Life on Duration of Activity
Substance Abuse Potential Drug Tolerance and Physical Dependency Hypersensitivity and Adverse Response Chapter Summary Learning Questions Answers References 22. Application of Pharmacokinetics to Clinical Situations Medication Therapy Management Individualization of Drug Dosage Regimens Therapeutic Drug Monitoring Clinical
Example Clinical Example Design of Dosage Regimens Conversion From Intravenous Infusion to Oral Dosing Determination of Dose Practice Problems Effect of Changing Dose ond Dosing Interval on C[sub(max)][sup(∞)], C[sub(min)][sup(∞)], and C[sub(av)][sup(∞) Determination of Frequency of Drug Administration Determination of Both Dose and
Dosage Interval Practice Problem Determination of Route of Administration Dosing Infants and Children Practice Problem Dosing the Elderly Practice Problems Clinical Example Dosing the Obese Patients Pharmacokinetics of Drug Interactions Inhibition of Drug Metabolism Inhibition of Monoamine Oxidase (MAO) Induction of Drug Metabolism
Inhibition of Drug Absorption Inhibition of Biliary Excretion Altered Renal Reabsorption Due to Changing Urinary pH Practical Focus Effect of Food on Drug Disposition Adverse Viral Drug Interactions Population Pharmacokinetics Clinical Example Regional Pharmacokinetics Chapter Summary Learning Questions Answers References Bibliography
23. Application of Pharmacokinetics to Specific Populations: Geriatric, Obese, and Pediatric Patients Specific and Special Populations Module I: Application of Pharmacokinetics to the Geriatric Patients Summary Learning Questions Answers References Further Reading Module II: Application of Pharmacokinetics to the Obese Patients Summary
Learning Questions Answers References Module III: Application of Pharmacokinetics to the Pediatric Patients Summary Learning Questions Answers References 24. Dose Adjustment in Renal and Hepatic Disease Renal Impairment Pharmacokinetic Considerations General Approaches for Dose Adjustment in Renal Disease Measurement of Glomerular
Filtration Rate Serum Creatinine Concentration and Creatinine Clearance Practice Problems Dose Adjustment for Uremic Patients Practice Problem Practice Problem Practice Problems Practice Problem Extracorporeal Removal of Drugs Practice Problem Clinical Examples Effect of Hepatic Disease on Pharmacokinetics Practice Problem Chapter
Summary Learning Questions Answers References Bibliography 25. Empirical Models, Mechanistic Models, Statistical Moments, and Noncompartmental Analysis Empirical Models Mechanistic Models Noncompartmental Analysis Comparison of Different Approaches Selection of Pharmacokinetic Models Chapter Summary Learning Questions Answers
References Bibliography Appendix A: Applications of Software Packages in Pharmacokinetics Appendix B: Glossary Index A B C D E F G H I J K L M N O P Q R S T U V W X Z Pharmacokinetics is the subject that deals with the rates of movement of a drug and/or its metabolite(s) in the body and forces acting on the process. Absorption, Distribution,
Metabolism and Excretion of drugs are the processes in which a drug moves in the body at various rates. Relative rates of these "ADME processes" determine the time courseof the drug in the body, the most important of the receptor sites which are responsible for the pharmacological action of drugs. Pharmacokinetics will explain the rates of
movement of drugs in the body with the help of a suitable mathematical [Link] pharmacokinetics, the concentration of a drug in plasma of any physiological fluid such as urine, saliva, milk etc., is determined with respect to time following its administration. The concentration of a drug in a physiological fluid versus time data is used to study the
dynamics of th~ drug in the body with the help of mathematical equations, derived on the basis of a model and set of [Link] therapeutic response of a drug is normally dependent on an adequate concentration of the drug being achieved and then maintained at the site or sites of action of the drug. In the case of systemically acting drugs it is
generally accepted for clinical purposes that a dynamic equilibrium exists between the concentration of drug in blood and the concentration of drug at its site(s) of action. It means a linear relationship exists between the drug level in blood and drug concentration at the site of action. Therefore, drug concentration at the site of action can be predicted
from blood concentration of drug. Strictly, the concentration of drug in plasma water (Le., protein free plasma) is a more accurate index of drug concentration at the site (s) of action than is the concentration of drug in whole plasma since a drug may often bind in a reversible manner to plasma protein. Only drug that is unbound (Le., dissolved in
plasma water) can pass out of the plasma through the capillary endothelium and reach other body fluids and tissues and hence its site (s) of [Link], to measure the concentration of an unbound drug in plasma water requires more complex and sensitive assay methods than to measure the total concentration of both unbound and bound drug
in [Link] on following Download: