Revising oral pharmacokinetics, bioavailability and bioequivalence based on the finite absorption time concept / / Panos Macheras and Athanasios A. Tsekouras

• Autore: Macheras P (Panos)
• Pubblicazione: Cham, Switzerland : , : Springer, , [2023]; ©2023
• Descrizione fisica: 1 online resource (137 pages)
• Disciplina: 615.7
• Soggetto topico: Drugs - Bioavailability; Drugs - Absorption and adsorption; Oral medication; Pharmacokinetics; Biological Availability; Biopharmaceutics; Drug Therapy
• Persona (resp. second.): TsekourasAthanasios A.
• Nota di bibliografia: Includes bibliographical references.
• Nota di contenuto: Intro -- 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.
• Titolo autorizzato: Revising oral pharmacokinetics, bioavailability and bioequivalence based on the finite absorption time concept
• ISBN: 3-031-20025-X
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9910639877503321
• Lo trovi qui: Univ. Federico II