21st century cures : modernizing clinical trials : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Thirteenth Congress, second session, July 9, 2014 |
Pubbl/distr/stampa | Washington : , : U.S. Government Publishing Office, , 2015 |
Descrizione fisica | 1 online resource (iv, 165 pages) |
Soggetto topico |
Clinical trials - United States
Drugs - United States - Testing Medical instruments and apparatus - United States - Testing Clinical trials Drugs - Testing Medical instruments and apparatus - Testing |
Soggetto genere / forma | Legislative hearings. |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | 21st century cures |
Record Nr. | UNINA-9910703523803321 |
Washington : , : U.S. Government Publishing Office, , 2015 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
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Accelerating the development of biomarkers for drug safety [[electronic resource] ] : workshop summary / / Steve Olson, Sally Robinson and Robert Giffin, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies |
Pubbl/distr/stampa | Washington, D.C., : National Academies Press, c2009 |
Descrizione fisica | 1 online resource (99 p.) |
Disciplina | 616.075 |
Altri autori (Persone) |
GiffinRobert B
OlsonSteve <1956-> RobinsonSally |
Soggetto topico |
Biochemical markers
Drugs - Safety measures Drugs - Testing |
Soggetto genere / forma | Electronic books. |
ISBN |
1-282-27265-9
9786612272653 0-309-13125-1 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Record Nr. | UNINA-9910454905103321 |
Washington, D.C., : National Academies Press, c2009 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Accelerating the development of biomarkers for drug safety [[electronic resource] ] : workshop summary / / Steve Olson, Sally Robinson and Robert Giffin, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies |
Pubbl/distr/stampa | Washington, D.C., : National Academies Press, c2009 |
Descrizione fisica | 1 online resource (99 p.) |
Disciplina | 616.075 |
Altri autori (Persone) |
GiffinRobert B
OlsonSteve <1956-> RobinsonSally |
Soggetto topico |
Biochemical markers
Drugs - Safety measures Drugs - Testing |
ISBN |
0-309-14231-8
1-282-27265-9 9786612272653 0-309-13125-1 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Overview Of key issues -- Cardiac safety biomarkers -- Assessing and predicting kidney safety -- Biomarkers of acute idiosyncratic hepatocellular injury in clinical trials -- Future considerations. |
Record Nr. | UNINA-9910778330203321 |
Washington, D.C., : National Academies Press, c2009 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Accelerating the development of biomarkers for drug safety : workshop summary / / Steve Olson, Sally Robinson and Robert Giffin, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies |
Edizione | [1st ed.] |
Pubbl/distr/stampa | Washington, D.C., : National Academies Press, c2009 |
Descrizione fisica | 1 online resource (99 p.) |
Disciplina | 616.075 |
Altri autori (Persone) |
GiffinRobert B
OlsonSteve <1956-> RobinsonSally |
Soggetto topico |
Biochemical markers
Drugs - Safety measures Drugs - Testing |
ISBN |
0-309-14231-8
1-282-27265-9 9786612272653 0-309-13125-1 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Overview Of key issues -- Cardiac safety biomarkers -- Assessing and predicting kidney safety -- Biomarkers of acute idiosyncratic hepatocellular injury in clinical trials -- Future considerations. |
Record Nr. | UNINA-9910828713903321 |
Washington, D.C., : National Academies Press, c2009 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Addendum to ICH S6 [[electronic resource] ] : preclinical safety evaluation of biotechnology-derived pharmaceuticals |
Pubbl/distr/stampa | [Rockville, Md.?] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [2009] |
Descrizione fisica | 1 online resource (iv, 14 pages) |
Soggetto topico |
Pharmaceutical biotechnology
Drugs - Testing |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Addendum to ICH S6 |
Record Nr. | UNINA-9910699222303321 |
[Rockville, Md.?] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [2009] | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
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ADMET for Medicinal Chemists [[electronic resource] ] : A Practical Guide |
Autore | Tsaioun Katya |
Pubbl/distr/stampa | Hoboken, : Wiley, 2012 |
Descrizione fisica | 1 online resource (524 p.) |
Disciplina |
615.19
615/.19 |
Altri autori (Persone) | KatesSteven A |
Soggetto topico |
Drug Design
Drug Toxicity Drugs - Testing Drugs --Testing --Juvenile literature Pharmaceutical Preparations - chemistry Pharmacokinetics Metabolic Phenomena Drug Discovery Pharmacological Phenomena Natural Science Disciplines Kinetics Chemicals and Drugs Poisoning Biochemical Phenomena Chemistry, Pharmaceutical Substance-Related Disorders Disciplines and Occupations Investigative Techniques Physiological Phenomena Phenomena and Processes Chemical Phenomena Diseases Pharmacology Analytical, Diagnostic and Therapeutic Techniques and Equipment Biological Science Disciplines Chemistry Pharmaceutical Preparations Health & Biological Sciences Pharmacy, Therapeutics, & Pharmacology |
ISBN |
1-280-59122-6
9786613621054 0-470-91509-9 0-470-91511-0 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
ADMET for Medicinal Chemists: A Practical Guide; CONTENTS; Preface; Contributors; 1 Introduction; 1.1 Introduction; 1.2 Voyage Through The Digestive System; 1.2.1 The Mouth; 1.2.2 The Stomach; 1.2.3 The Small Intestine: Duodenum; 1.2.4 The Small and Large Intestine: Jejunum, Ileum, Colon; 1.2.5 Hepatic-Portal Vein; 1.3 The Liver Metabolism; 1.3.1 CYP450 (CYPs); 1.4 The Kidneys; 1.4.1 Active Tubular Secretion; 1.4.2 Passive Tubular Reabsorption; 1.5 Conclusions; References; 2 In Silico ADME/Tox Predictions; 2.1 Introduction; 2.2 Key Computer Methods for ADME/Tox Predictions
2.2.1 Drug Discovery2.2.2 Applying or Not ADME/Tox Predictions, Divided Opinions; 2.2.3 In Silico ADME/Tox Methods and Modeling Approaches; 2.2.4 Physicochemistry, Pharmacokinetics, Drug-Like and Lead-Like Concepts; 2.2.5 Lipophilicity; 2.2.6 pKa; 2.2.7 Transport Proteins; 2.2.8 Plasma Protein Binding; 2.2.9 Metabolism; 2.2.10 Elimination; 2.2.11 Toxicity; 2.3 Preparation of Compound Collections and Computer Programs, Challenging ADME/Tox Predictions and Statistical Methods; 2.3.1 Preparation of Compound Collections and Computer Programs 2.3.2 Preparing a Compound Collection: Materials and Methods2.3.3 Cleaning and Designing the Compound Collection; 2.3.4 Searching for Similarity; 2.3.5 Generating 3D Structures; 2.4 ADME/Tox Predictions within Pharmaceutics Companies; 2.4.1 Actelion Pharmaceuticals Ltd.; 2.4.2 Bayer; 2.4.3 Bristol-Myers Squibb; 2.4.4 Hoffmann-La Roche Ltd.; 2.4.5 Neurogen Corporation; 2.4.6 Novartis; 2.4.7 Schering AG; 2.4.8 Vertex Pharmaceuticals; 2.5 Challenging ADME/Tox Predictions; 2.5.1 Tolcapone; 2.5.2 Factor V Inhibitors; 2.5.3 CRF-1 Receptor Antagonists; 2.6 Statistical Methods 2.6.1 Principal Component Analysis2.6.2 Partial Least Square; 2.6.3 Support Vector Machine; 2.6.4 Decision Trees; 2.6.5 Neural Networks; 2.7 Conclusions; References; 3 Absorption and Physicochemical Properties of the NCE; 3.1. Introduction; 3.2. Physicochemical Properties; 3.3. Stability; 3.4. Dissolution and Solubility; 3.4.1. Dissolution Rate, Particle Size, and Solubility; 3.4.2. pH and Salts; 3.4.3. In Vivo Solubilization; 3.5. Solid State; References; 4 ADME; 4.1 Introduction; 4.2 Absorption; 4.2.1 Route of Administration; 4.2.2 Factors Determining Oral Bioavailability; 4.3 Distribution 4.3.1 Drug Distribution4.3.2 Volume of Distribution; 4.3.3 Free Drug Concentration; 4.3.4 CNS Penetration; 4.4 Elimination; 4.4.1 Elimination Versus Clearance; 4.4.2 Metabolism Versus Excretion; 4.4.3 Drug-Free Fraction and Clearance; 4.4.4 Lipophilicity and Clearance; 4.4.5 Transporters and Clearance; 4.4.6 Metabolism; 4.4.7 Excretion; 4.5 Drug Interactions; 4.5.1 Absorption-Driven DDI; 4.5.2 Distribution-Driven DDI; 4.5.3 Excretion-Driven DDI; 4.5.4 Metabolism-Driven DDI; 4.5.5 Tools for Studying Drug Metabolism; 4.5.6 Applications of Drug Metabolism Tools 4.5.7 Tools for Studying Drug Excretion |
Record Nr. | UNINA-9910133588303321 |
Tsaioun Katya | ||
Hoboken, : Wiley, 2012 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
ADMET for Medicinal Chemists [[electronic resource] ] : A Practical Guide |
Autore | Tsaioun Katya |
Pubbl/distr/stampa | Hoboken, : Wiley, 2012 |
Descrizione fisica | 1 online resource (524 p.) |
Disciplina |
615.19
615/.19 |
Altri autori (Persone) | KatesSteven A |
Soggetto topico |
Drug Design
Drug Toxicity Drugs - Testing Drugs --Testing --Juvenile literature Pharmaceutical Preparations - chemistry Pharmacokinetics Metabolic Phenomena Drug Discovery Pharmacological Phenomena Natural Science Disciplines Kinetics Chemicals and Drugs Poisoning Biochemical Phenomena Chemistry, Pharmaceutical Substance-Related Disorders Disciplines and Occupations Investigative Techniques Physiological Phenomena Phenomena and Processes Chemical Phenomena Diseases Pharmacology Analytical, Diagnostic and Therapeutic Techniques and Equipment Biological Science Disciplines Chemistry Pharmaceutical Preparations Health & Biological Sciences Pharmacy, Therapeutics, & Pharmacology |
ISBN |
1-280-59122-6
9786613621054 0-470-91509-9 0-470-91511-0 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
ADMET for Medicinal Chemists: A Practical Guide; CONTENTS; Preface; Contributors; 1 Introduction; 1.1 Introduction; 1.2 Voyage Through The Digestive System; 1.2.1 The Mouth; 1.2.2 The Stomach; 1.2.3 The Small Intestine: Duodenum; 1.2.4 The Small and Large Intestine: Jejunum, Ileum, Colon; 1.2.5 Hepatic-Portal Vein; 1.3 The Liver Metabolism; 1.3.1 CYP450 (CYPs); 1.4 The Kidneys; 1.4.1 Active Tubular Secretion; 1.4.2 Passive Tubular Reabsorption; 1.5 Conclusions; References; 2 In Silico ADME/Tox Predictions; 2.1 Introduction; 2.2 Key Computer Methods for ADME/Tox Predictions
2.2.1 Drug Discovery2.2.2 Applying or Not ADME/Tox Predictions, Divided Opinions; 2.2.3 In Silico ADME/Tox Methods and Modeling Approaches; 2.2.4 Physicochemistry, Pharmacokinetics, Drug-Like and Lead-Like Concepts; 2.2.5 Lipophilicity; 2.2.6 pKa; 2.2.7 Transport Proteins; 2.2.8 Plasma Protein Binding; 2.2.9 Metabolism; 2.2.10 Elimination; 2.2.11 Toxicity; 2.3 Preparation of Compound Collections and Computer Programs, Challenging ADME/Tox Predictions and Statistical Methods; 2.3.1 Preparation of Compound Collections and Computer Programs 2.3.2 Preparing a Compound Collection: Materials and Methods2.3.3 Cleaning and Designing the Compound Collection; 2.3.4 Searching for Similarity; 2.3.5 Generating 3D Structures; 2.4 ADME/Tox Predictions within Pharmaceutics Companies; 2.4.1 Actelion Pharmaceuticals Ltd.; 2.4.2 Bayer; 2.4.3 Bristol-Myers Squibb; 2.4.4 Hoffmann-La Roche Ltd.; 2.4.5 Neurogen Corporation; 2.4.6 Novartis; 2.4.7 Schering AG; 2.4.8 Vertex Pharmaceuticals; 2.5 Challenging ADME/Tox Predictions; 2.5.1 Tolcapone; 2.5.2 Factor V Inhibitors; 2.5.3 CRF-1 Receptor Antagonists; 2.6 Statistical Methods 2.6.1 Principal Component Analysis2.6.2 Partial Least Square; 2.6.3 Support Vector Machine; 2.6.4 Decision Trees; 2.6.5 Neural Networks; 2.7 Conclusions; References; 3 Absorption and Physicochemical Properties of the NCE; 3.1. Introduction; 3.2. Physicochemical Properties; 3.3. Stability; 3.4. Dissolution and Solubility; 3.4.1. Dissolution Rate, Particle Size, and Solubility; 3.4.2. pH and Salts; 3.4.3. In Vivo Solubilization; 3.5. Solid State; References; 4 ADME; 4.1 Introduction; 4.2 Absorption; 4.2.1 Route of Administration; 4.2.2 Factors Determining Oral Bioavailability; 4.3 Distribution 4.3.1 Drug Distribution4.3.2 Volume of Distribution; 4.3.3 Free Drug Concentration; 4.3.4 CNS Penetration; 4.4 Elimination; 4.4.1 Elimination Versus Clearance; 4.4.2 Metabolism Versus Excretion; 4.4.3 Drug-Free Fraction and Clearance; 4.4.4 Lipophilicity and Clearance; 4.4.5 Transporters and Clearance; 4.4.6 Metabolism; 4.4.7 Excretion; 4.5 Drug Interactions; 4.5.1 Absorption-Driven DDI; 4.5.2 Distribution-Driven DDI; 4.5.3 Excretion-Driven DDI; 4.5.4 Metabolism-Driven DDI; 4.5.5 Tools for Studying Drug Metabolism; 4.5.6 Applications of Drug Metabolism Tools 4.5.7 Tools for Studying Drug Excretion |
Record Nr. | UNINA-9910830164603321 |
Tsaioun Katya | ||
Hoboken, : Wiley, 2012 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
ADMET for medicinal chemists : a practical guide / / edited by Katya Tsaioun, Steven A. Kates |
Pubbl/distr/stampa | Hoboken, N.J., : John Wiley & Sons, c2011 |
Descrizione fisica | 1 online resource (524 p.) |
Disciplina |
615.19
615/.19 |
Altri autori (Persone) |
KatesSteven A. <1961->
TsaiounKatya |
Soggetto topico |
Drugs - Testing
Drugs - Design |
ISBN |
1-280-59122-6
9786613621054 0-470-91509-9 0-470-91511-0 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
ADMET for Medicinal Chemists: A Practical Guide; CONTENTS; Preface; Contributors; 1 Introduction; 1.1 Introduction; 1.2 Voyage Through The Digestive System; 1.2.1 The Mouth; 1.2.2 The Stomach; 1.2.3 The Small Intestine: Duodenum; 1.2.4 The Small and Large Intestine: Jejunum, Ileum, Colon; 1.2.5 Hepatic-Portal Vein; 1.3 The Liver Metabolism; 1.3.1 CYP450 (CYPs); 1.4 The Kidneys; 1.4.1 Active Tubular Secretion; 1.4.2 Passive Tubular Reabsorption; 1.5 Conclusions; References; 2 In Silico ADME/Tox Predictions; 2.1 Introduction; 2.2 Key Computer Methods for ADME/Tox Predictions
2.2.1 Drug Discovery2.2.2 Applying or Not ADME/Tox Predictions, Divided Opinions; 2.2.3 In Silico ADME/Tox Methods and Modeling Approaches; 2.2.4 Physicochemistry, Pharmacokinetics, Drug-Like and Lead-Like Concepts; 2.2.5 Lipophilicity; 2.2.6 pKa; 2.2.7 Transport Proteins; 2.2.8 Plasma Protein Binding; 2.2.9 Metabolism; 2.2.10 Elimination; 2.2.11 Toxicity; 2.3 Preparation of Compound Collections and Computer Programs, Challenging ADME/Tox Predictions and Statistical Methods; 2.3.1 Preparation of Compound Collections and Computer Programs 2.3.2 Preparing a Compound Collection: Materials and Methods2.3.3 Cleaning and Designing the Compound Collection; 2.3.4 Searching for Similarity; 2.3.5 Generating 3D Structures; 2.4 ADME/Tox Predictions within Pharmaceutics Companies; 2.4.1 Actelion Pharmaceuticals Ltd.; 2.4.2 Bayer; 2.4.3 Bristol-Myers Squibb; 2.4.4 Hoffmann-La Roche Ltd.; 2.4.5 Neurogen Corporation; 2.4.6 Novartis; 2.4.7 Schering AG; 2.4.8 Vertex Pharmaceuticals; 2.5 Challenging ADME/Tox Predictions; 2.5.1 Tolcapone; 2.5.2 Factor V Inhibitors; 2.5.3 CRF-1 Receptor Antagonists; 2.6 Statistical Methods 2.6.1 Principal Component Analysis2.6.2 Partial Least Square; 2.6.3 Support Vector Machine; 2.6.4 Decision Trees; 2.6.5 Neural Networks; 2.7 Conclusions; References; 3 Absorption and Physicochemical Properties of the NCE; 3.1. Introduction; 3.2. Physicochemical Properties; 3.3. Stability; 3.4. Dissolution and Solubility; 3.4.1. Dissolution Rate, Particle Size, and Solubility; 3.4.2. pH and Salts; 3.4.3. In Vivo Solubilization; 3.5. Solid State; References; 4 ADME; 4.1 Introduction; 4.2 Absorption; 4.2.1 Route of Administration; 4.2.2 Factors Determining Oral Bioavailability; 4.3 Distribution 4.3.1 Drug Distribution4.3.2 Volume of Distribution; 4.3.3 Free Drug Concentration; 4.3.4 CNS Penetration; 4.4 Elimination; 4.4.1 Elimination Versus Clearance; 4.4.2 Metabolism Versus Excretion; 4.4.3 Drug-Free Fraction and Clearance; 4.4.4 Lipophilicity and Clearance; 4.4.5 Transporters and Clearance; 4.4.6 Metabolism; 4.4.7 Excretion; 4.5 Drug Interactions; 4.5.1 Absorption-Driven DDI; 4.5.2 Distribution-Driven DDI; 4.5.3 Excretion-Driven DDI; 4.5.4 Metabolism-Driven DDI; 4.5.5 Tools for Studying Drug Metabolism; 4.5.6 Applications of Drug Metabolism Tools 4.5.7 Tools for Studying Drug Excretion |
Altri titoli varianti | Absorption, distribution, metabolism, excretion, toxicity for medical chemists |
Record Nr. | UNINA-9910876861103321 |
Hoboken, N.J., : John Wiley & Sons, c2011 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
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Advances in collating and using trial data / / Sylvie Chevret, Matthieu Resche-Rigon, editors |
Pubbl/distr/stampa | London, England : , : Future Science Ltd, , 2014 |
Descrizione fisica | 1 online resource (90 pages) : illustrations (some color) |
Disciplina | 615.1901 |
Soggetto topico |
Drugs - Testing
Drug development |
Soggetto genere / forma | Electronic books. |
ISBN |
1-909453-27-7
1-909453-28-5 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Record Nr. | UNINA-9910464757503321 |
London, England : , : Future Science Ltd, , 2014 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Advances in collating and using trial data / / Sylvie Chevret, Matthieu Resche-Rigon, editors |
Pubbl/distr/stampa | London, England : , : Future Science Ltd, , 2014 |
Descrizione fisica | 1 online resource (90 pages) : illustrations (some color) |
Disciplina | 615.1901 |
Soggetto topico |
Drugs - Testing
Drug development |
ISBN |
1-909453-27-7
1-909453-28-5 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Record Nr. | UNINA-9910789329703321 |
London, England : , : Future Science Ltd, , 2014 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|