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Approved drug products with therapeutic equivalence evaluations
| Approved drug products with therapeutic equivalence evaluations |
| Pubbl/distr/stampa | [Rockville, Md.], : U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Drugs and Biologics |
| Descrizione fisica | 1 online resource (volumes) |
| Disciplina |
615
615/.1 |
| Soggetto topico |
Drugs - Therapeutic equivalency
Drugs - Bioavailability Drugs Pharmaceutical services insurance Medical care - United States Medical care Pharmaceutical Preparations Therapeutic Equivalency |
| Soggetto genere / forma |
Catalogs.
Periodicals. Catalog Periodical |
| ISSN | 2158-7744 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Orange book |
| Record Nr. | UNINA-9910132234103321 |
| [Rockville, Md.], : U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Drugs and Biologics | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Drug bioavailability [[electronic resource] ] : estimation of solubility, permeability, absorption and bioavailability
| Drug bioavailability [[electronic resource] ] : estimation of solubility, permeability, absorption and bioavailability |
| Edizione | [2nd, completely rev. ed /] |
| Pubbl/distr/stampa | Weinheim, : Wiley-VCH, c2009 |
| Descrizione fisica | 1 online resource (653 p.) |
| Disciplina |
615.19
664.06 |
| Altri autori (Persone) |
WaterbeemdHan van de
TestaBernard |
| Collana | Methods and principles in medicinal chemistry |
| Soggetto topico |
Drugs - Bioavailability
Pharmaceutical chemistry |
| ISBN |
1-282-30704-5
9786612307041 3-527-62386-8 3-527-62387-6 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Drug Bioavailability: Estimation of Solubility, Permeability, Absorption and Bioavailability; Contents; List of Contributors; Preface; A Personal Foreword; 1 Introduction: The Why and How of Drug Bioavailability Research; 1.1 Dening Bioavailability; 1.1.1 The Biological Context; 1.1.2 A Pharmacokinetic Overview; 1.1.3 Specic Issues; 1.2 Presentation and Layout of the Book; References; Part One Physicochemical Aspects of Drug Dissolution and Solubility; 2 Aqueous Solubility in Drug Discovery Chemistry, DMPK, and Biological Assays; 2.1 Introduction; 2.1.1 Denition of Aqueous Solubility
2.1.2 Aqueous Solubility in Different Phases of Drug Discovery2.2 Aqueous Solubility in Hit Identication; 2.2.1 Aqueous Solubility from DMSO Solutions; 2.2.1.1 Turbidimetric Methods; 2.2.1.2 UV Absorption Methods; 2.2.1.3 Alternative Detection Methodology; 2.2.1.4 Application of DMSO-Based Solubility Assays; 2.3 Aqueous Solubility in Lead Identication and Lead Optimization; 2.3.1 Dried-Down Solution Methods; 2.3.2 Solubility from Solid; 2.3.3 Thermodynamic Solubility Assays with Solid-State Characterization; 2.3.4 Solubility by Potentiometry 2.3.5 Application of Thermodynamic Solubility Data in LI and LO2.4 Conclusions; References; 3 Gastrointestinal Dissolution and Absorption of Class II Drugs; 3.1 Introduction; 3.2 Drug Absorption and the BCS; 3.3 Class II Drugs; 3.4 GI Physiological Variables Affecting Class II Drug Dissolution; 3.4.1 Bile Salts; 3.4.2 GI pH; 3.4.3 GI Transit; 3.4.4 Drug Particle Size; 3.4.5 Volume Available for Dissolution; 3.5 In Vitro Dissolution Tests for Class II Drugs; 3.5.1 Biorelevant Media; 3.5.2 Dynamic Lipolysis Model; 3.6 BCS-Based FDA Guidelines: Implications for Class II Drugs 3.6.1 Potential of Redening BCS Solubility Class Boundary3.6.2 Biowaiver Extension Potential for Class II Drugs; 3.7 Conclusions; References; 4 In Silico Prediction of Solubility; 4.1 Introduction; 4.2 What Solubility Measures to Model?; 4.3 Is the Data Set Suitable for Modeling?; 4.4 Descriptors and Modeling Methods for Developing Solubility Models; 4.5 Comparing Literature Solubility Models; 4.6 What Is the Inuence of the Domain of Applicability?; 4.7 Can We Tell when Good Predictions Are Made?; 4.8 Conclusions; References Part Two Physicochemical and Biological Studies of Membrane Permeability and Oral Absorption5 Physicochemical Approaches to Drug Absorption; 5.1 Introduction; 5.2 Physicochemical Properties and Pharmacokinetics; 5.2.1 DMPK; 5.2.2 Lipophilicity, Permeability, and Absorption; 5.2.3 Estimation of Volume of Distribution from Physical Chemistry; 5.2.4 Plasma Protein Binding and Physicochemical Properties; 5.3 Dissolution and Solubility; 5.3.1 Calculated Solubility; 5.4 Ionization (pKa); 5.4.1 Calculated pKa; 5.5 Molecular Size and Shape; 5.5.1 Calculated Size Descriptors; 5.6 Hydrogen Bonding 5.6.1 Calculated Hydrogen-Bonding Descriptors |
| Record Nr. | UNINA-9910139907503321 |
| Weinheim, : Wiley-VCH, c2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Drug bioavailability [[electronic resource] ] : estimation of solubility, permeability, absorption and bioavailability
| Drug bioavailability [[electronic resource] ] : estimation of solubility, permeability, absorption and bioavailability |
| Edizione | [2nd, completely rev. ed /] |
| Pubbl/distr/stampa | Weinheim, : Wiley-VCH, c2009 |
| Descrizione fisica | 1 online resource (653 p.) |
| Disciplina |
615.19
664.06 |
| Altri autori (Persone) |
WaterbeemdHan van de
TestaBernard |
| Collana | Methods and principles in medicinal chemistry |
| Soggetto topico |
Drugs - Bioavailability
Pharmaceutical chemistry |
| ISBN |
1-282-30704-5
9786612307041 3-527-62386-8 3-527-62387-6 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Drug Bioavailability: Estimation of Solubility, Permeability, Absorption and Bioavailability; Contents; List of Contributors; Preface; A Personal Foreword; 1 Introduction: The Why and How of Drug Bioavailability Research; 1.1 Dening Bioavailability; 1.1.1 The Biological Context; 1.1.2 A Pharmacokinetic Overview; 1.1.3 Specic Issues; 1.2 Presentation and Layout of the Book; References; Part One Physicochemical Aspects of Drug Dissolution and Solubility; 2 Aqueous Solubility in Drug Discovery Chemistry, DMPK, and Biological Assays; 2.1 Introduction; 2.1.1 Denition of Aqueous Solubility
2.1.2 Aqueous Solubility in Different Phases of Drug Discovery2.2 Aqueous Solubility in Hit Identication; 2.2.1 Aqueous Solubility from DMSO Solutions; 2.2.1.1 Turbidimetric Methods; 2.2.1.2 UV Absorption Methods; 2.2.1.3 Alternative Detection Methodology; 2.2.1.4 Application of DMSO-Based Solubility Assays; 2.3 Aqueous Solubility in Lead Identication and Lead Optimization; 2.3.1 Dried-Down Solution Methods; 2.3.2 Solubility from Solid; 2.3.3 Thermodynamic Solubility Assays with Solid-State Characterization; 2.3.4 Solubility by Potentiometry 2.3.5 Application of Thermodynamic Solubility Data in LI and LO2.4 Conclusions; References; 3 Gastrointestinal Dissolution and Absorption of Class II Drugs; 3.1 Introduction; 3.2 Drug Absorption and the BCS; 3.3 Class II Drugs; 3.4 GI Physiological Variables Affecting Class II Drug Dissolution; 3.4.1 Bile Salts; 3.4.2 GI pH; 3.4.3 GI Transit; 3.4.4 Drug Particle Size; 3.4.5 Volume Available for Dissolution; 3.5 In Vitro Dissolution Tests for Class II Drugs; 3.5.1 Biorelevant Media; 3.5.2 Dynamic Lipolysis Model; 3.6 BCS-Based FDA Guidelines: Implications for Class II Drugs 3.6.1 Potential of Redening BCS Solubility Class Boundary3.6.2 Biowaiver Extension Potential for Class II Drugs; 3.7 Conclusions; References; 4 In Silico Prediction of Solubility; 4.1 Introduction; 4.2 What Solubility Measures to Model?; 4.3 Is the Data Set Suitable for Modeling?; 4.4 Descriptors and Modeling Methods for Developing Solubility Models; 4.5 Comparing Literature Solubility Models; 4.6 What Is the Inuence of the Domain of Applicability?; 4.7 Can We Tell when Good Predictions Are Made?; 4.8 Conclusions; References Part Two Physicochemical and Biological Studies of Membrane Permeability and Oral Absorption5 Physicochemical Approaches to Drug Absorption; 5.1 Introduction; 5.2 Physicochemical Properties and Pharmacokinetics; 5.2.1 DMPK; 5.2.2 Lipophilicity, Permeability, and Absorption; 5.2.3 Estimation of Volume of Distribution from Physical Chemistry; 5.2.4 Plasma Protein Binding and Physicochemical Properties; 5.3 Dissolution and Solubility; 5.3.1 Calculated Solubility; 5.4 Ionization (pKa); 5.4.1 Calculated pKa; 5.5 Molecular Size and Shape; 5.5.1 Calculated Size Descriptors; 5.6 Hydrogen Bonding 5.6.1 Calculated Hydrogen-Bonding Descriptors |
| Record Nr. | UNINA-9910830618603321 |
| Weinheim, : Wiley-VCH, c2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Drug bioavailability : estimation of solubility, permeability, absorption and bioavailability
| Drug bioavailability : estimation of solubility, permeability, absorption and bioavailability |
| Edizione | [2nd, completely rev. ed /] |
| Pubbl/distr/stampa | Weinheim, : Wiley-VCH, c2009 |
| Descrizione fisica | 1 online resource (653 p.) |
| Disciplina |
615.19
664.06 |
| Altri autori (Persone) |
WaterbeemdHan van de
TestaBernard |
| Collana | Methods and principles in medicinal chemistry |
| Soggetto topico |
Drugs - Bioavailability
Pharmaceutical chemistry |
| ISBN |
9786612307041
9781282307049 1282307045 9783527623860 3527623868 9783527623877 3527623876 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Drug Bioavailability: Estimation of Solubility, Permeability, Absorption and Bioavailability; Contents; List of Contributors; Preface; A Personal Foreword; 1 Introduction: The Why and How of Drug Bioavailability Research; 1.1 Dening Bioavailability; 1.1.1 The Biological Context; 1.1.2 A Pharmacokinetic Overview; 1.1.3 Specic Issues; 1.2 Presentation and Layout of the Book; References; Part One Physicochemical Aspects of Drug Dissolution and Solubility; 2 Aqueous Solubility in Drug Discovery Chemistry, DMPK, and Biological Assays; 2.1 Introduction; 2.1.1 Denition of Aqueous Solubility
2.1.2 Aqueous Solubility in Different Phases of Drug Discovery2.2 Aqueous Solubility in Hit Identication; 2.2.1 Aqueous Solubility from DMSO Solutions; 2.2.1.1 Turbidimetric Methods; 2.2.1.2 UV Absorption Methods; 2.2.1.3 Alternative Detection Methodology; 2.2.1.4 Application of DMSO-Based Solubility Assays; 2.3 Aqueous Solubility in Lead Identication and Lead Optimization; 2.3.1 Dried-Down Solution Methods; 2.3.2 Solubility from Solid; 2.3.3 Thermodynamic Solubility Assays with Solid-State Characterization; 2.3.4 Solubility by Potentiometry 2.3.5 Application of Thermodynamic Solubility Data in LI and LO2.4 Conclusions; References; 3 Gastrointestinal Dissolution and Absorption of Class II Drugs; 3.1 Introduction; 3.2 Drug Absorption and the BCS; 3.3 Class II Drugs; 3.4 GI Physiological Variables Affecting Class II Drug Dissolution; 3.4.1 Bile Salts; 3.4.2 GI pH; 3.4.3 GI Transit; 3.4.4 Drug Particle Size; 3.4.5 Volume Available for Dissolution; 3.5 In Vitro Dissolution Tests for Class II Drugs; 3.5.1 Biorelevant Media; 3.5.2 Dynamic Lipolysis Model; 3.6 BCS-Based FDA Guidelines: Implications for Class II Drugs 3.6.1 Potential of Redening BCS Solubility Class Boundary3.6.2 Biowaiver Extension Potential for Class II Drugs; 3.7 Conclusions; References; 4 In Silico Prediction of Solubility; 4.1 Introduction; 4.2 What Solubility Measures to Model?; 4.3 Is the Data Set Suitable for Modeling?; 4.4 Descriptors and Modeling Methods for Developing Solubility Models; 4.5 Comparing Literature Solubility Models; 4.6 What Is the Inuence of the Domain of Applicability?; 4.7 Can We Tell when Good Predictions Are Made?; 4.8 Conclusions; References Part Two Physicochemical and Biological Studies of Membrane Permeability and Oral Absorption5 Physicochemical Approaches to Drug Absorption; 5.1 Introduction; 5.2 Physicochemical Properties and Pharmacokinetics; 5.2.1 DMPK; 5.2.2 Lipophilicity, Permeability, and Absorption; 5.2.3 Estimation of Volume of Distribution from Physical Chemistry; 5.2.4 Plasma Protein Binding and Physicochemical Properties; 5.3 Dissolution and Solubility; 5.3.1 Calculated Solubility; 5.4 Ionization (pKa); 5.4.1 Calculated pKa; 5.5 Molecular Size and Shape; 5.5.1 Calculated Size Descriptors; 5.6 Hydrogen Bonding 5.6.1 Calculated Hydrogen-Bonding Descriptors |
| Record Nr. | UNINA-9911020074203321 |
| Weinheim, : Wiley-VCH, c2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Drug bioavailability [[electronic resource] ] : estimation of solubility, permeability, absorption and bioavailability / / edited by Han van de Waterbeemd, Hans Lennernäs and Per Artursson
| Drug bioavailability [[electronic resource] ] : estimation of solubility, permeability, absorption and bioavailability / / edited by Han van de Waterbeemd, Hans Lennernäs and Per Artursson |
| Pubbl/distr/stampa | Weinheim, : Wiley-VCH, c2003 |
| Descrizione fisica | 1 online resource (605 p.) |
| Disciplina |
615.1
615.19 615/.7 |
| Altri autori (Persone) |
WaterbeemdHan van de
LennernäsHans ArturssonPer |
| Collana | Methods and principles in medicinal chemistry |
| Soggetto topico |
Drugs - Bioavailability
Drugs - Solubility |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-280-52024-8
9786610520244 3-527-60515-0 3-527-60147-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Drug Bioavailability Estimation of Solubility, Permeability, Absorption and Bioavailability; Contents; Preface; Foreword; List of Authors; I Studies of Membrane Permeability and Oral Absorption; 1 Physico-chemical Approaches to Drug Absorption; Abbreviations; Symbols; 1.1 Introduction; 1.2 Drug-like Properties; 1.3 Dissolution and Solubility; 1.3.1 Calculated Solubility; 1.4 Ionization (pK(a)); 1.5 Lipophilicity; 1.5.1 Calculated log P; 1.6 Molecular Size and Shape; 1.6.1 Calculated Size Descriptors; 1.7 Hydrogen Bonding; 1.7.1 Calculated Hydrogen-Bonding Descriptors; 1.8 Amphiphilicity
1.9 Permeability1.9.1 Artificial Membranes; 1.9.2 IAM, ILC, MEKC, and BMC; 1.9.3 Liposome Partitioning; 1.9.4 Biosensors; 1.9.5 Ghost Erythrocytes and Diffusion Constants; References; 2 High-throughput Measurement of log D and pK(a); Abbreviations; Symbols; 2.1 Introduction; 2.2 Relationship between Ionization and Lipophilicity; 2.3 Measuring log D; 2.3.1 Shake-flask Method; 2.3.2 pH-metric Method; 2.3.3 Direct Chromatographic Methods; 2.3.3.1 Chromatographic Hydrophobicity Index (CHI); 2.3.3.2 Microemulsion Electrokinetic Chromatography (MEEKC) 2.3.3.3 Chromatography in the Presence of Octanol2.3.3.4 Reversed-Phase Chromatography; 2.3.3.5 Liquid-Liquid Partition Chromatography; 2.4 Measuring pK(a); 2.4.1 Review of Methods; 2.4.2 The Effect of Co-solvents on pK(a); 2.4.3 pH-Metric Titration; 2.4.4 Hybrid pH-Metric/UV Method; 2.4.5 Other Methods; 2.4.6 pH Gradient Titration; 2.5 Some Thoughts about High-throughput Analytical Chemistry; Acknowledgments; References; 3 High-throughput Measurement of Permeability Profiles; Abbreviations; Symbols; 3.1 Introduction 3.2 Key Historical Developments in Artificial-Membrane Permeability Measurement3.3 The Ideal in vitro Artificial Membrane Permeability Model; 3.3.1 Lipid Compositions in Biological Membranes; 3.3.2 Permeability-pH Considerations; 3.3.3 Role of Serum Proteins; 3.3.4 Effects of Cosolvents, Bile Acids, and other Surfactants; 3.3.5 Components of the Ideal; 3.4 New Directions in PAMPA; 3.4.1 Concentrated and Charged Phospholipid Membranes; 3.4.2 Gradient-pH Permeability Equation; 3.4.3 Permeability Measurements: High-phospholipid in Surfactant-free Solutions 3.4.4 Membrane Retention Measurements: High-phospholipid in Surfactant-free Solutions3.4.5 Egg Lecithin and the Degree of Negative Charge; 3.4.6 Summary: Increasing Phospholipid Content in the Absence of Sink Conditions; 3.4.7 Effects of Surfactant on High-phospholipid Membrane Permeability and Retention; 3.4.8 Quality and Usefulness of the UV Spectra; 3.4.9 Iso-pH and Gradient-pH Mapping in 2% DOPC-Dodecane; 3.4.10 Iso-pH Mapping in 20% Soy Lecithin-Dodecane, with Surfactant 3.4.11 Predictions of in vivo Human Jejunal Permeabilities using the Improved 20% Soy Lecithin with Surfactant in vitro PAMPA Technique |
| Record Nr. | UNINA-9910146243203321 |
| Weinheim, : Wiley-VCH, c2003 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Drug bioavailability : estimation of solubility, permeability, absorption and bioavailability / / edited by Han van de Waterbeemd, Hans Lennernäs and Per Artursson
| Drug bioavailability : estimation of solubility, permeability, absorption and bioavailability / / edited by Han van de Waterbeemd, Hans Lennernäs and Per Artursson |
| Pubbl/distr/stampa | Weinheim, : Wiley-VCH, c2003 |
| Descrizione fisica | 1 online resource (605 p.) |
| Disciplina |
615.1
615.19 615/.7 |
| Altri autori (Persone) |
WaterbeemdHan van de
LennernäsHans ArturssonPer |
| Collana | Methods and principles in medicinal chemistry |
| Soggetto topico |
Drugs - Bioavailability
Drugs - Solubility |
| ISBN |
1-280-52024-8
9786610520244 3-527-60515-0 3-527-60147-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Drug Bioavailability Estimation of Solubility, Permeability, Absorption and Bioavailability; Contents; Preface; Foreword; List of Authors; I Studies of Membrane Permeability and Oral Absorption; 1 Physico-chemical Approaches to Drug Absorption; Abbreviations; Symbols; 1.1 Introduction; 1.2 Drug-like Properties; 1.3 Dissolution and Solubility; 1.3.1 Calculated Solubility; 1.4 Ionization (pK(a)); 1.5 Lipophilicity; 1.5.1 Calculated log P; 1.6 Molecular Size and Shape; 1.6.1 Calculated Size Descriptors; 1.7 Hydrogen Bonding; 1.7.1 Calculated Hydrogen-Bonding Descriptors; 1.8 Amphiphilicity
1.9 Permeability1.9.1 Artificial Membranes; 1.9.2 IAM, ILC, MEKC, and BMC; 1.9.3 Liposome Partitioning; 1.9.4 Biosensors; 1.9.5 Ghost Erythrocytes and Diffusion Constants; References; 2 High-throughput Measurement of log D and pK(a); Abbreviations; Symbols; 2.1 Introduction; 2.2 Relationship between Ionization and Lipophilicity; 2.3 Measuring log D; 2.3.1 Shake-flask Method; 2.3.2 pH-metric Method; 2.3.3 Direct Chromatographic Methods; 2.3.3.1 Chromatographic Hydrophobicity Index (CHI); 2.3.3.2 Microemulsion Electrokinetic Chromatography (MEEKC) 2.3.3.3 Chromatography in the Presence of Octanol2.3.3.4 Reversed-Phase Chromatography; 2.3.3.5 Liquid-Liquid Partition Chromatography; 2.4 Measuring pK(a); 2.4.1 Review of Methods; 2.4.2 The Effect of Co-solvents on pK(a); 2.4.3 pH-Metric Titration; 2.4.4 Hybrid pH-Metric/UV Method; 2.4.5 Other Methods; 2.4.6 pH Gradient Titration; 2.5 Some Thoughts about High-throughput Analytical Chemistry; Acknowledgments; References; 3 High-throughput Measurement of Permeability Profiles; Abbreviations; Symbols; 3.1 Introduction 3.2 Key Historical Developments in Artificial-Membrane Permeability Measurement3.3 The Ideal in vitro Artificial Membrane Permeability Model; 3.3.1 Lipid Compositions in Biological Membranes; 3.3.2 Permeability-pH Considerations; 3.3.3 Role of Serum Proteins; 3.3.4 Effects of Cosolvents, Bile Acids, and other Surfactants; 3.3.5 Components of the Ideal; 3.4 New Directions in PAMPA; 3.4.1 Concentrated and Charged Phospholipid Membranes; 3.4.2 Gradient-pH Permeability Equation; 3.4.3 Permeability Measurements: High-phospholipid in Surfactant-free Solutions 3.4.4 Membrane Retention Measurements: High-phospholipid in Surfactant-free Solutions3.4.5 Egg Lecithin and the Degree of Negative Charge; 3.4.6 Summary: Increasing Phospholipid Content in the Absence of Sink Conditions; 3.4.7 Effects of Surfactant on High-phospholipid Membrane Permeability and Retention; 3.4.8 Quality and Usefulness of the UV Spectra; 3.4.9 Iso-pH and Gradient-pH Mapping in 2% DOPC-Dodecane; 3.4.10 Iso-pH Mapping in 20% Soy Lecithin-Dodecane, with Surfactant 3.4.11 Predictions of in vivo Human Jejunal Permeabilities using the Improved 20% Soy Lecithin with Surfactant in vitro PAMPA Technique |
| Record Nr. | UNINA-9910877382003321 |
| Weinheim, : Wiley-VCH, c2003 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : food-effect bioavailability and fed bioequivalence studies
| Guidance for industry [[electronic resource] ] : food-effect bioavailability and fed bioequivalence studies |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2002] |
| Descrizione fisica | 1 online resource (9 pages) |
| Soggetto topico |
Drugs - Bioavailability
Drugs - Therapeutic equivalency |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910699059003321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2002] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Oral bioavailability [[electronic resource] ] : basic principles, advanced concepts, and applications / / edited by Ming Hu, Xiaoling Li
| Oral bioavailability [[electronic resource] ] : basic principles, advanced concepts, and applications / / edited by Ming Hu, Xiaoling Li |
| Pubbl/distr/stampa | Hoboken, NJ, : John Wiley & Sons, c2011 |
| Descrizione fisica | 1 online resource (570 p.) |
| Disciplina | 615/.19 |
| Altri autori (Persone) |
HuMing, Ph. D.
LiXiaoling <1957-> |
| Collana | Wiley series in drug discovery and development |
| Soggetto topico |
Drugs - Bioavailability
Drug development Intestinal absorption |
| ISBN |
1-283-25776-9
9786613257765 1-118-06758-4 1-118-06759-2 1-118-06752-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
ORAL BIOAVAILABILITY; CONTENTS; Foreword; Preface; Contributors; 1 Barriers to Oral Bioavailability-An Overview; 2 Physicochemical Characterization of Pharmaceutical Solids; 3 Solubility of Pharmaceutical Solids; 4 In Vitro Dissolution of Pharmaceutical Solids; 5 Biological and Physiological Features of the Gastrointestinal Tract Relevant to Oral Drug Absorption; 6 Absorption of Drugs via Passive Diffusion and Carrier-Mediated Pathways; 7 In Vitro-In Vivo Correlations of Pharmaceutical Dosage Forms; 8 Drug Metabolism in Gastrointestinal Tract
9 Efflux of Drugs via Transporters-The Antiabsorption Pathway 10 Liver Drug Metabolism; 11 Protein Binding of Drugs; 12 Urinary Excretion of Drugs and Drug Reabsorption; 13 Pharmacokinetic Behaviors of Orally Administered Drugs; 14 Effects of Food on Drug Absorption; 15 Drug-Drug Interactions and Drug-Dietary Chemical Interactions; 16 Anatomical and Physiological Factors Affecting Oral Drug Bioavailability in Rats, Dogs, and Humans; 17 Amino Acid Drug Transporters; 18 Drug Transporters and Their Role in Absorption and Disposition of Peptides and Peptide-Based Pharmaceuticals 19 Organic Anion and Cation Drug Transporters 20 Gastric Retentive Drug Delivery Systems; 21 Lipid-Based and Self-Emulsifying Oral Drug Delivery Systems; 22 Prodrug Strategies to Enhance Oral Drug Absorption; 23 Oral Delivery of Protein/Peptide Therapeutics; 24 ABC Transporters in Intestinal and Liver Efflux; 25 Interplay Between Efflux Transporters and Metabolic Enzymes; 26 Regulatory Considerations in Metabolism- and Transporter-Based Drug Interactions; 27 Caco-2 Cell Culture Model for Oral Drug Absorption; 28 MDCK Cells and Other Cell-Culture Models of Oral Drug Absorption 29 Intestinal Perfusion Methods for Oral Drug Absorptions 30 Liver Perfusion and Primary Hepatocytes for Studying Drug Metabolism and Metabolite Excretion; 31 In vivo Methods for Oral Bioavailability Studies; 32 Determination of Regulation of Drug-Metabolizing Enzymes and Transporters; 33 Computational and Pharmacoinformatic Approaches to Oral Bioavailability Prediction; Index |
| Record Nr. | UNINA-9910139611803321 |
| Hoboken, NJ, : John Wiley & Sons, c2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Oral bioavailability : basic principles, advanced concepts, and applications / / edited by Ming Hu, Xiaoling Li
| Oral bioavailability : basic principles, advanced concepts, and applications / / edited by Ming Hu, Xiaoling Li |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Hoboken, NJ, : John Wiley & Sons, c2011 |
| Descrizione fisica | 1 online resource (570 p.) |
| Disciplina | 615/.19 |
| Altri autori (Persone) |
HuMing, Ph. D.
LiXiaoling <1957-> |
| Collana | Wiley series in drug discovery and development |
| Soggetto topico |
Drugs - Bioavailability
Drug development Intestinal absorption |
| ISBN |
9786613257765
9781283257763 1283257769 9781118067581 1118067584 9781118067598 1118067592 9781118067529 1118067525 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
ORAL BIOAVAILABILITY; CONTENTS; Foreword; Preface; Contributors; 1 Barriers to Oral Bioavailability-An Overview; 2 Physicochemical Characterization of Pharmaceutical Solids; 3 Solubility of Pharmaceutical Solids; 4 In Vitro Dissolution of Pharmaceutical Solids; 5 Biological and Physiological Features of the Gastrointestinal Tract Relevant to Oral Drug Absorption; 6 Absorption of Drugs via Passive Diffusion and Carrier-Mediated Pathways; 7 In Vitro-In Vivo Correlations of Pharmaceutical Dosage Forms; 8 Drug Metabolism in Gastrointestinal Tract
9 Efflux of Drugs via Transporters-The Antiabsorption Pathway 10 Liver Drug Metabolism; 11 Protein Binding of Drugs; 12 Urinary Excretion of Drugs and Drug Reabsorption; 13 Pharmacokinetic Behaviors of Orally Administered Drugs; 14 Effects of Food on Drug Absorption; 15 Drug-Drug Interactions and Drug-Dietary Chemical Interactions; 16 Anatomical and Physiological Factors Affecting Oral Drug Bioavailability in Rats, Dogs, and Humans; 17 Amino Acid Drug Transporters; 18 Drug Transporters and Their Role in Absorption and Disposition of Peptides and Peptide-Based Pharmaceuticals 19 Organic Anion and Cation Drug Transporters 20 Gastric Retentive Drug Delivery Systems; 21 Lipid-Based and Self-Emulsifying Oral Drug Delivery Systems; 22 Prodrug Strategies to Enhance Oral Drug Absorption; 23 Oral Delivery of Protein/Peptide Therapeutics; 24 ABC Transporters in Intestinal and Liver Efflux; 25 Interplay Between Efflux Transporters and Metabolic Enzymes; 26 Regulatory Considerations in Metabolism- and Transporter-Based Drug Interactions; 27 Caco-2 Cell Culture Model for Oral Drug Absorption; 28 MDCK Cells and Other Cell-Culture Models of Oral Drug Absorption 29 Intestinal Perfusion Methods for Oral Drug Absorptions 30 Liver Perfusion and Primary Hepatocytes for Studying Drug Metabolism and Metabolite Excretion; 31 In vivo Methods for Oral Bioavailability Studies; 32 Determination of Regulation of Drug-Metabolizing Enzymes and Transporters; 33 Computational and Pharmacoinformatic Approaches to Oral Bioavailability Prediction; Index |
| Record Nr. | UNINA-9910808327803321 |
| Hoboken, NJ, : John Wiley & Sons, c2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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