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Clinical trials [[electronic resource] ] : study design, endpoints and biomarkers, drug safety, FDA and ICH guidelines / / Tom Brody
Clinical trials [[electronic resource] ] : study design, endpoints and biomarkers, drug safety, FDA and ICH guidelines / / Tom Brody
Autore Brody Tom
Edizione [1st ed.]
Pubbl/distr/stampa London, : Academic Press, 2012
Descrizione fisica 1 online resource (673 p.)
Disciplina 615.19
615.50724
615/.19
Soggetto topico Clinical trials
Drugs - Testing
Soggetto genere / forma Electronic books.
ISBN 1-283-32021-5
9786613320216
0-12-391913-4
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Front Cover; Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, FDA and ICH Guidelines; Copyright Page; Contents; Acknowledgments; Preface; The Study Schema and Study Design; Intent to Treat Analysis; How to Choose the Endpoints; Diagnostic Tests; Mechanism of Action; Standards; Methodology; Clinicaltrials.Gov and other Registries for Clinical Trials; Introduction; Abbreviations and Definitions; Biography; 1 The Origins of Drugs; I. Introduction; II. Structures of Drugs; a. Origins of warfarin; b. Origins of methotrexate and 5-fluorouracil; c. Origins of ribavirin
d. Origins of paclitaxele. Origins of cladribine; f. Origins of drugs in high-throughput screening; g. Origins of therapeutic antibodies; III. The 20 Classical Amino Acids; IV. Animal Models; a. Introduction; b. Estimating human dose from animal studies; 1. NOAEL approach; 2. MABEL approach; c. Scaling up the drug dose, acquired from animal studies, for use in humans; 2 Introduction to Regulated Clinical Trials; I. Introduction; II. Study Design; III. The Study Schema; a. Examples of schema from clinical trials; b. Sequential treatment versus concurrent treatment - the Perez schema
c. Neoadjuvant chemotherapy versus adjuvant chemotherapy - the Gianni schemad. Neoadjuvant chemotherapy plus adjuvant chemotherapy - the Untch schema; e. Forwards sequence and reverse sequence - the Puhalla schema; f. Both arms received three drugs, each arm at a different schedule - the Sekine schema; g. Staging - the Blumenschein schema; h. Staging and restaging - the Czito schema; i. Methodology tip - staging; j. Decision tree - the Baselga schema; k. Decision tree - the Katsumata schema; l. Methodology tip - what is "tumor progression"?
m. Methodology tip - unit of drug dose expressed in terms of body surface arean. Run-in period - the schema of Dy; o. Methodology tip - c-kit and imatinib; p. Run-in period - the Hanna schema; q. How to maintain blinding of the treatment, when the study drug and the control treatment are provided by different-sized pills (or by different volumes of solutions)...; r. Methodology tip - bevacizumab and VEGF; s. Dose escalation - the Moore schema; t. Pharmacokinetics - the Marshall schema; IV. Further Concepts In Study Design; a. Active control; b. Add-on design active control
c. Three-arm study - clinical trial with two different active control armsV. Summary; VI. Amendments to the Clinical Study Protocol; 3 Run-In Period; I. Introduction; a. Washout period; b. Detecting baseline adverse events; c. Excluding potential study subjects who have safety issues correlating with the study drug; d. To include only study subjects with controllable pain; e. To determine the maximal tolerable dose; f. To achieve and ensure steady state in vivo concentrations of study drug
g. To allow a period of adjustment of lifestyle of the study subjects, for example changes in dietary patterns
Record Nr. UNINA-9910457469003321
Brody Tom  
London, : Academic Press, 2012
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Clinical trials [[electronic resource] ] : study design, endpoints and biomarkers, drug safety, FDA and ICH guidelines / / Tom Brody
Clinical trials [[electronic resource] ] : study design, endpoints and biomarkers, drug safety, FDA and ICH guidelines / / Tom Brody
Autore Brody Tom
Edizione [1st ed.]
Pubbl/distr/stampa London, : Academic Press, 2012
Descrizione fisica 1 online resource (673 p.)
Disciplina 615.19
615.50724
615/.19
Soggetto topico Clinical trials
Drugs - Testing
ISBN 1-283-32021-5
9786613320216
0-12-391913-4
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Front Cover; Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, FDA and ICH Guidelines; Copyright Page; Contents; Acknowledgments; Preface; The Study Schema and Study Design; Intent to Treat Analysis; How to Choose the Endpoints; Diagnostic Tests; Mechanism of Action; Standards; Methodology; Clinicaltrials.Gov and other Registries for Clinical Trials; Introduction; Abbreviations and Definitions; Biography; 1 The Origins of Drugs; I. Introduction; II. Structures of Drugs; a. Origins of warfarin; b. Origins of methotrexate and 5-fluorouracil; c. Origins of ribavirin
d. Origins of paclitaxele. Origins of cladribine; f. Origins of drugs in high-throughput screening; g. Origins of therapeutic antibodies; III. The 20 Classical Amino Acids; IV. Animal Models; a. Introduction; b. Estimating human dose from animal studies; 1. NOAEL approach; 2. MABEL approach; c. Scaling up the drug dose, acquired from animal studies, for use in humans; 2 Introduction to Regulated Clinical Trials; I. Introduction; II. Study Design; III. The Study Schema; a. Examples of schema from clinical trials; b. Sequential treatment versus concurrent treatment - the Perez schema
c. Neoadjuvant chemotherapy versus adjuvant chemotherapy - the Gianni schemad. Neoadjuvant chemotherapy plus adjuvant chemotherapy - the Untch schema; e. Forwards sequence and reverse sequence - the Puhalla schema; f. Both arms received three drugs, each arm at a different schedule - the Sekine schema; g. Staging - the Blumenschein schema; h. Staging and restaging - the Czito schema; i. Methodology tip - staging; j. Decision tree - the Baselga schema; k. Decision tree - the Katsumata schema; l. Methodology tip - what is "tumor progression"?
m. Methodology tip - unit of drug dose expressed in terms of body surface arean. Run-in period - the schema of Dy; o. Methodology tip - c-kit and imatinib; p. Run-in period - the Hanna schema; q. How to maintain blinding of the treatment, when the study drug and the control treatment are provided by different-sized pills (or by different volumes of solutions)...; r. Methodology tip - bevacizumab and VEGF; s. Dose escalation - the Moore schema; t. Pharmacokinetics - the Marshall schema; IV. Further Concepts In Study Design; a. Active control; b. Add-on design active control
c. Three-arm study - clinical trial with two different active control armsV. Summary; VI. Amendments to the Clinical Study Protocol; 3 Run-In Period; I. Introduction; a. Washout period; b. Detecting baseline adverse events; c. Excluding potential study subjects who have safety issues correlating with the study drug; d. To include only study subjects with controllable pain; e. To determine the maximal tolerable dose; f. To achieve and ensure steady state in vivo concentrations of study drug
g. To allow a period of adjustment of lifestyle of the study subjects, for example changes in dietary patterns
Record Nr. UNINA-9910781962303321
Brody Tom  
London, : Academic Press, 2012
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Clinical trials [[electronic resource] ] : study design, endpoints and biomarkers, drug safety, FDA and ICH guidelines / / Tom Brody
Clinical trials [[electronic resource] ] : study design, endpoints and biomarkers, drug safety, FDA and ICH guidelines / / Tom Brody
Autore Brody Tom
Edizione [1st ed.]
Pubbl/distr/stampa London, : Academic Press, 2012
Descrizione fisica 1 online resource (673 p.)
Disciplina 615.19
615.50724
615/.19
Soggetto topico Clinical trials
Drugs - Testing
ISBN 1-283-32021-5
9786613320216
0-12-391913-4
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Front Cover; Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, FDA and ICH Guidelines; Copyright Page; Contents; Acknowledgments; Preface; The Study Schema and Study Design; Intent to Treat Analysis; How to Choose the Endpoints; Diagnostic Tests; Mechanism of Action; Standards; Methodology; Clinicaltrials.Gov and other Registries for Clinical Trials; Introduction; Abbreviations and Definitions; Biography; 1 The Origins of Drugs; I. Introduction; II. Structures of Drugs; a. Origins of warfarin; b. Origins of methotrexate and 5-fluorouracil; c. Origins of ribavirin
d. Origins of paclitaxele. Origins of cladribine; f. Origins of drugs in high-throughput screening; g. Origins of therapeutic antibodies; III. The 20 Classical Amino Acids; IV. Animal Models; a. Introduction; b. Estimating human dose from animal studies; 1. NOAEL approach; 2. MABEL approach; c. Scaling up the drug dose, acquired from animal studies, for use in humans; 2 Introduction to Regulated Clinical Trials; I. Introduction; II. Study Design; III. The Study Schema; a. Examples of schema from clinical trials; b. Sequential treatment versus concurrent treatment - the Perez schema
c. Neoadjuvant chemotherapy versus adjuvant chemotherapy - the Gianni schemad. Neoadjuvant chemotherapy plus adjuvant chemotherapy - the Untch schema; e. Forwards sequence and reverse sequence - the Puhalla schema; f. Both arms received three drugs, each arm at a different schedule - the Sekine schema; g. Staging - the Blumenschein schema; h. Staging and restaging - the Czito schema; i. Methodology tip - staging; j. Decision tree - the Baselga schema; k. Decision tree - the Katsumata schema; l. Methodology tip - what is "tumor progression"?
m. Methodology tip - unit of drug dose expressed in terms of body surface arean. Run-in period - the schema of Dy; o. Methodology tip - c-kit and imatinib; p. Run-in period - the Hanna schema; q. How to maintain blinding of the treatment, when the study drug and the control treatment are provided by different-sized pills (or by different volumes of solutions)...; r. Methodology tip - bevacizumab and VEGF; s. Dose escalation - the Moore schema; t. Pharmacokinetics - the Marshall schema; IV. Further Concepts In Study Design; a. Active control; b. Add-on design active control
c. Three-arm study - clinical trial with two different active control armsV. Summary; VI. Amendments to the Clinical Study Protocol; 3 Run-In Period; I. Introduction; a. Washout period; b. Detecting baseline adverse events; c. Excluding potential study subjects who have safety issues correlating with the study drug; d. To include only study subjects with controllable pain; e. To determine the maximal tolerable dose; f. To achieve and ensure steady state in vivo concentrations of study drug
g. To allow a period of adjustment of lifestyle of the study subjects, for example changes in dietary patterns
Record Nr. UNINA-9910817835703321
Brody Tom  
London, : Academic Press, 2012
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
FDA's drug review process and the package label : strategies for writing successful FDA submissions / / Tom Brody
FDA's drug review process and the package label : strategies for writing successful FDA submissions / / Tom Brody
Autore Brody Tom
Pubbl/distr/stampa Cambridge, Massachusetts : , : Academic Press, , 2018
Descrizione fisica 1 online resource (654 pages)
Disciplina 353.00778
Soggetto topico Drug approval - Safety regulations - United States
ISBN 0-12-814648-6
0-12-814647-8
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto 1. Introduction to regulated clinical trials -- 2. FDA's decision-making process when assessing ambiguous data -- 3. Food effect studies -- 4. Dose modification and dose titration -- 5. Contraindications -- 6. Animal studies -- 7. Drug-drug interactions: part one (small molecule drugs) -- 8. Drug-drug interactions: part two (therapeutic proteins) -- 9. Immunosuppression, drug-induced hypersensitivity reactions, and drug-induced autoimmune reactions -- 10. Drug class analysis -- 11. Relatedness -- 12. Adjudication of clinical data -- 13. Coding -- 14. Pooling.
Record Nr. UNINA-9910583499103321
Brody Tom  
Cambridge, Massachusetts : , : Academic Press, , 2018
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Nutritional biochemistry [[electronic resource] /] / Tom Brody
Nutritional biochemistry [[electronic resource] /] / Tom Brody
Autore Brody Tom
Edizione [2nd ed.]
Pubbl/distr/stampa San Diego, : Academic Press, c1994
Descrizione fisica 1 online resource (xix, 1006 pages)
Disciplina 612.3/9 21
612.39
Soggetto topico Nutrition
Metabolism
Soggetto genere / forma Electronic books.
ISBN 1-281-02585-2
9786611025854
0-08-051291-7
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Classification of biological structures-- Digestion and absorption-- Nutrients that resist or escape digestion-- Regulation of energy metabolism-- Energy requirement-- Lipids-- Obesity-- Protein-- Vitamins-- Inorganic nutrients-- Diet and cancer-- Nutrition methodology-- Dot blots, molecular cloning, and DNA sequencing-- Methods and terms in epidemiology.
Record Nr. UNINA-9910458721103321
Brody Tom  
San Diego, : Academic Press, c1994
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Nutritional biochemistry [[electronic resource] /] / Tom Brody
Nutritional biochemistry [[electronic resource] /] / Tom Brody
Autore Brody Tom
Edizione [2nd ed.]
Pubbl/distr/stampa San Diego, : Academic Press, c1994
Descrizione fisica 1 online resource (xix, 1006 pages)
Disciplina 612.3/9 21
612.39
Soggetto topico Nutrition
Metabolism
ISBN 1-281-02585-2
9786611025854
0-08-051291-7
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Classification of biological structures-- Digestion and absorption-- Nutrients that resist or escape digestion-- Regulation of energy metabolism-- Energy requirement-- Lipids-- Obesity-- Protein-- Vitamins-- Inorganic nutrients-- Diet and cancer-- Nutrition methodology-- Dot blots, molecular cloning, and DNA sequencing-- Methods and terms in epidemiology.
Record Nr. UNINA-9910784643903321
Brody Tom  
San Diego, : Academic Press, c1994
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Nutritional biochemistry [[electronic resource] /] / Tom Brody
Nutritional biochemistry [[electronic resource] /] / Tom Brody
Autore Brody Tom
Edizione [2nd ed.]
Pubbl/distr/stampa San Diego, : Academic Press, c1994
Descrizione fisica 1 online resource (xix, 1006 pages)
Disciplina 612.3/9 21
612.39
Soggetto topico Nutrition
Metabolism
ISBN 1-281-02585-2
9786611025854
0-08-051291-7
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Classification of biological structures-- Digestion and absorption-- Nutrients that resist or escape digestion-- Regulation of energy metabolism-- Energy requirement-- Lipids-- Obesity-- Protein-- Vitamins-- Inorganic nutrients-- Diet and cancer-- Nutrition methodology-- Dot blots, molecular cloning, and DNA sequencing-- Methods and terms in epidemiology.
Record Nr. UNINA-9910811453203321
Brody Tom  
San Diego, : Academic Press, c1994
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui