Revising Oral Pharmacokinetics, Bioavailability and Bioequivalence Based on the Finite Absorption Time Concept

Foreword
Preface
Contents
Part I: Oral Pharmacokinetics
	Chapter 1: From Bateman (1910) to Dost (1953)
		1.1 Harry Bateman: First-Order Kinetics in Physics (1910)
		1.2 Friedrich Hartmut Dost: First-Order Kinetics in Pharmacokinetics (1953)
		1.3 Simulations Based on Bateman´s Equation
		1.4 The Fundamental Metrics of Bioavailability/Bioequivalence Studies
		References
	Chapter 2: The Unphysical Hypothesis of Infinite Absorption Time
		2.1 The Biopharmaceutical-Pharmacokinetic Basis of the Bateman Equation
		2.2 State of the Art in Oral Drug Absorption
			2.2.1 The PK Route
				2.2.1.1 Questioning the Absorption Rate Constant, ka
				2.2.1.2 PBPK Models
			2.2.2 The Bioph Route
			2.2.3 The Absorption Rate Constant (ka) Links the Bioph and PK Routes
		2.3 The Unphysical Hypothesis of Infinite Absorption Time
		2.4 Concluding Remarks
		References
	Chapter 3: The Finite Absorption Time (FAT) Concept
		3.1 Sink Conditions Imply Zero-Order Kinetics
		3.2 Finite Absorption Time
			3.2.1 Modeling Work: Combining BCS with Absorption Kinetics
		3.3 Simulations
			3.3.1 Physiological Considerations
			3.3.2 Drug Absorption: Reconsidered in Terms of the FAT
		3.4 Fits to Data
		3.5 Epilogue
		References
	Chapter 4: The Rise of Physiologically Based Finite Time Pharmacokinetic (PBFTPK) Models
		4.1 Models
		4.2 Simulations
		4.3 Fits to Data
		4.4 Toward a Biopharmaceutics-Pharmacokinetic Classification System (BPCS)
		4.5 Future Work
		References
Part II: Bioavailability-Bioequivalence
	Chapter 5: History of the Bioavailability-Bioequivalence Concepts
		5.1 Early 1900s-Today: Variations in Response to Xenobiotics
		5.2 1950s: The First Pharmacokinetic-Pharmacodynamic Correlations
		5.3 1953: The Publication of Dost´s First Pharmacokinetics Book in History
		5.4 1960s: Biopharmaceutics-Pharmacokinetics at Its Infancy
		5.5 ``The Bioavailability Problem´´
		5.6 The Introduction of an Official Dissolution Test in 1970 (USP Apparatus 1)
		5.7 FDA (1977): Bioavailability Is the Rate and Extent to Which the Active Ingredient or Active Moiety Is Absorbed from a Drug...
			5.7.1 A Persisting Problem: The Use of Cmax as a Metric of Rate of Absorption
		References
	Chapter 6: Therapeutic Equivalence Based on Bioequivalence Studies
		6.1 From 1977 to Now: Bioequivalence Criteria and Issues
		6.2 Highly Variable Drugs or Drug Products (HVD)
		6.3 Epilogue
		References
	Chapter 7: Bioavailability Under the Prism of Finite Absorption Time
		7.1 The Columbus´ Egg: Drug Absorption Takes Place Under Sink Conditions for Finite Time
		7.2 A Paradigm Shift in Oral Drug Absorption
		7.3 Bioavailability Parameters Under the Prism of Finite Absorption Time Concept
			7.3.1 One Compartment Model with One Constant Input Rate Operating for Time τ
			7.3.2 One Compartment Model with More than One Constant Input Rates Operating for a Total Time τ
			7.3.3 One Compartment Model with First-Order Absorption Lasting for Time τ and First-Order Elimination
		7.4 Extent (Exposure) and Rate Metrics
		7.5 Extent and Rate of Absorption Metrics Under the Prism of Finite Absorption Time (FAT)
		7.6 Scientific-Regulatory Implications
		7.7 Toward the Unthinkable: Estimation of Absolute Bioavailability from Oral Data Exclusively
		References
	Chapter 8: Bioequivalence Under the Prism of Finite Absorption Time
		8.1 Reconsidering Digoxin Bioavailability/Bioequivalence Studies in the Light of Finite Absorption Time Concept
		8.2  Is the Proper Metric for Drug´s Extent of Absorption
		8.3 Toward the Revision of Bioequivalence Assessment
		8.4 Does FDA´s Bioavailability Definition of 1977 Require Reconsideration?
		References