Chiral separation methods for pharmaceutical and biotechnological products [[electronic resource] /] / Satinder Ahuja |
Autore | Ahuja Satinder <1933-> |
Pubbl/distr/stampa | Hoboken, N.J., : Wiley, c2011 |
Descrizione fisica | 1 online resource (508 p.) |
Disciplina |
615.19
615/.19 |
Soggetto topico |
Chiral drugs - Separation
Enantiomers - Separation |
Soggetto genere / forma | Electronic books. |
ISBN |
1-118-09775-0
1-282-88343-7 9786612883439 0-470-60866-8 0-470-60865-X |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
CHIRAL SEPARATION METHODS FOR PHARMACEUTICAL AND BIOTECHNOLOGICAL PRODUCTS; CONTENTS; Contributors; Preface; 1 Overview of Chiral Separations; 2 Regulatory and Development Considerations of Chiral Compounds; 3 Basic Considerations in HPLC Method Development of Chiral Compounds; 4 Separation of Chiral Compounds on Polysaccharide Columns; 5 Chiral Separations by Various Techniques; 6 Chiral Discrimination Study for Polysaccharide-Based Chiral Stationary Phases; 7 Comparison of Chiral Chromatography Columns for Pharmaceutical Method Development
8 Chiral Screening Methods for Pharmaceutical Analysis and Purification in an Industrial Laboratory9 Separation of Enantiomers by Gas Chromatography on Chiral Stationary Phases; 10 Separations of Chiral Compounds by SFC; 11 Chiral Separations by Capillary Electrophoresis; 12 High-Throughput Screening and Method Development Strategies to Separate Chiral Drug Compounds in HPLC, SFC, and CE; 13 Use of Enantioselective Synthesis and Preparative Chiral Chromatography to Access a Challenging Enantiopure Pharmaceutical Candidate from a Mixture of Four Stereoisomers 14 A Look into the Future: Chiral Analysis Using Chemical Sensor Technology15 Chirality of Biomolecules and Biotechnology Products; Index |
Record Nr. | UNINA-9910140905303321 |
Ahuja Satinder <1933-> | ||
Hoboken, N.J., : Wiley, c2011 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Chiral separation methods for pharmaceutical and biotechnological products [[electronic resource] /] / Satinder Ahuja |
Autore | Ahuja Satinder <1933-> |
Pubbl/distr/stampa | Hoboken, N.J., : Wiley, c2011 |
Descrizione fisica | 1 online resource (508 p.) |
Disciplina |
615.19
615/.19 |
Soggetto topico |
Chiral drugs - Separation
Enantiomers - Separation |
ISBN |
1-118-09775-0
1-282-88343-7 9786612883439 0-470-60866-8 0-470-60865-X |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
CHIRAL SEPARATION METHODS FOR PHARMACEUTICAL AND BIOTECHNOLOGICAL PRODUCTS; CONTENTS; Contributors; Preface; 1 Overview of Chiral Separations; 2 Regulatory and Development Considerations of Chiral Compounds; 3 Basic Considerations in HPLC Method Development of Chiral Compounds; 4 Separation of Chiral Compounds on Polysaccharide Columns; 5 Chiral Separations by Various Techniques; 6 Chiral Discrimination Study for Polysaccharide-Based Chiral Stationary Phases; 7 Comparison of Chiral Chromatography Columns for Pharmaceutical Method Development
8 Chiral Screening Methods for Pharmaceutical Analysis and Purification in an Industrial Laboratory9 Separation of Enantiomers by Gas Chromatography on Chiral Stationary Phases; 10 Separations of Chiral Compounds by SFC; 11 Chiral Separations by Capillary Electrophoresis; 12 High-Throughput Screening and Method Development Strategies to Separate Chiral Drug Compounds in HPLC, SFC, and CE; 13 Use of Enantioselective Synthesis and Preparative Chiral Chromatography to Access a Challenging Enantiopure Pharmaceutical Candidate from a Mixture of Four Stereoisomers 14 A Look into the Future: Chiral Analysis Using Chemical Sensor Technology15 Chirality of Biomolecules and Biotechnology Products; Index |
Record Nr. | UNINA-9910830060103321 |
Ahuja Satinder <1933-> | ||
Hoboken, N.J., : Wiley, c2011 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Chiral separation methods for pharmaceutical and biotechnological products [[electronic resource] /] / Satinder Ahuja |
Autore | Ahuja Satinder <1933-> |
Pubbl/distr/stampa | Hoboken, N.J., : Wiley, c2011 |
Descrizione fisica | 1 online resource (508 p.) |
Disciplina |
615.19
615/.19 |
Soggetto topico |
Chiral drugs - Separation
Enantiomers - Separation |
ISBN |
1-118-09775-0
1-282-88343-7 9786612883439 0-470-60866-8 0-470-60865-X |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
CHIRAL SEPARATION METHODS FOR PHARMACEUTICAL AND BIOTECHNOLOGICAL PRODUCTS; CONTENTS; Contributors; Preface; 1 Overview of Chiral Separations; 2 Regulatory and Development Considerations of Chiral Compounds; 3 Basic Considerations in HPLC Method Development of Chiral Compounds; 4 Separation of Chiral Compounds on Polysaccharide Columns; 5 Chiral Separations by Various Techniques; 6 Chiral Discrimination Study for Polysaccharide-Based Chiral Stationary Phases; 7 Comparison of Chiral Chromatography Columns for Pharmaceutical Method Development
8 Chiral Screening Methods for Pharmaceutical Analysis and Purification in an Industrial Laboratory9 Separation of Enantiomers by Gas Chromatography on Chiral Stationary Phases; 10 Separations of Chiral Compounds by SFC; 11 Chiral Separations by Capillary Electrophoresis; 12 High-Throughput Screening and Method Development Strategies to Separate Chiral Drug Compounds in HPLC, SFC, and CE; 13 Use of Enantioselective Synthesis and Preparative Chiral Chromatography to Access a Challenging Enantiopure Pharmaceutical Candidate from a Mixture of Four Stereoisomers 14 A Look into the Future: Chiral Analysis Using Chemical Sensor Technology15 Chirality of Biomolecules and Biotechnology Products; Index |
Record Nr. | UNINA-9910841716803321 |
Ahuja Satinder <1933-> | ||
Hoboken, N.J., : Wiley, c2011 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Cleaning validation manual : a comprehensive guide for the pharmaceutical and biotechnology industries / / Syed Imtiaz Haider, Erfan Syed Asif |
Autore | Haider Syed Imtiaz |
Pubbl/distr/stampa | Boca Raton : , : CRC Press, , 2010 |
Descrizione fisica | 1 online resource (610 p.) |
Disciplina | 615/.19 |
Altri autori (Persone) | AsifErfan Syed |
Soggetto topico |
Pharmaceutical industry - Equipment and supplies - Sterilization
Drug factories - Cleaning |
Soggetto genere / forma | Electronic books. |
ISBN |
0-429-15225-6
1-4398-2661-7 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
Front cover; Contents; List of Figures; List of Tables; About the Book; Preface; Acknowledgments; Authors; Introduction; Disclaimer; CLV-1: How to Establish a Cleaning Validation Program; Body; CLV-2: Introduction; CLV-3: Scope and Approach; CLV-4: Cleaning Validation Team Membersand Responsibilities; CLV-5: Cleaning Validation Philosophy, Strategies,and Methodology; CLV-6: Planning Phase; CLV-7: Execution Phase; CLV-8: Analytical Testing and Reporting Phase; CLV-9: Equipment Description; CLV-10: Facility Description; CLV-11: Utilities Description: DIW, WFI, Steam,and Compressed Air
CLV-12: Utilities Monitoring and Microbiological ControlCLV-13: Equipment Cleaning Materials/DetergentDescription; CLV-14: Microbiological Cleaning of Equipment Surface; CLV-15: Solubility of Active Materials in Water; CLV-16: Toxicity of Active Materials; CLV-17: Cleaning Validation Products Grouping Matrix (Tablets, Capsules, and PPS); CLV-18: Product/Equipment Train Matrix (Tab-Cap-PPS); CLV-19: Worst-Case Products (Tablets, Capsules,and PPS) Matrix; CLV-20: Validation with Corresponding Cleaning Procedures; CLV-20.1: Cleaning Validation Protocol for Fluid Bed Dryer CLV-20.2: Cleaning Validation Protocol for MixerCLV-20.3: Cleaning Validation Protocol for Granulation Machines (Type A); CLV-20.4: Cleaning Validation Protocol for Powder Bins; CLV-20.5: Cleaning Validation Protocol for Tablet Press; CLV-20.6: Cleaning Validation Protocol for Sieve; CLV-20.7: Cleaning Validation Protocol for Powder-Filling Machine; CLV-20.8: Cleaning Validation Protocol for Encapsulation Machine; CLV-20.9: Cleaning Validation Protocol for Film-Coating Pan; CLV-20.10: Cleaning Validation Protocol for Sugar-Coating Pan CLV-21: Cleaning Validation Product Grouping Matrix (Syrup)CLV-22: Cleaning Validation Product/Equipment Train (Syrup); CLV-23: Worst-Case Products (Syrup; CLV-24: Cleaning Validation Product Grouping Matrix (Suspension); CLV-25: Product Grouping/Equipment Train Matrix (Suspension); CLV-26: Worst-Case Products (Suspension); CLV-27: Product Grouping Matrix (Drops); CLV-28: Product/Equipment Train (Drops); CLV-29: Worst-Case Products (Drops); CLV-30: Cleaning Validation Product Grouping Matrix (Cream/Ointment); CLV-31: Product/Equipment Train (Cream and Ointment) CLV-32: Worst-Case Products (Ointment and Cream)CLV-33: Product Grouping Matrix (Suppositories); CLV-34: Cleaning Validation Product/Equipment Train (Suppositories); CLV-35: Worst-Case Products (Suppositories); CLV-36: Cleaning Validation Protocols Products (Suppositories); CLV-36.1 Protocol for Manufacturing Vessel; CLV-36.2 Protocol for Bin-Washing Station; CLV-36.3 Cleaning Validation Protocol for Syrup-Holding Tank; CLV-36.4: Protocol for Filling Station and Filter Assembly; CLV-37: Cleaning Validation Product Grouping Matrix (Sterile) CLV-38 Cleaning Validation Product/Equipment Train Matrix (Sterile) |
Record Nr. | UNINA-9910459137203321 |
Haider Syed Imtiaz | ||
Boca Raton : , : CRC Press, , 2010 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Cleaning validation manual : a comprehensive guide for the pharmaceutical and biotechnology industries / / Syed Imtiaz Haider, Erfan Syed Asif |
Autore | Haider Syed Imtiaz |
Pubbl/distr/stampa | Boca Raton : , : CRC Press, , 2010 |
Descrizione fisica | 1 online resource (610 p.) |
Disciplina | 615/.19 |
Altri autori (Persone) | AsifErfan Syed |
Soggetto topico |
Pharmaceutical industry - Equipment and supplies - Sterilization
Drug factories - Cleaning |
ISBN |
0-429-15225-6
1-4398-2661-7 |
Classificazione |
VN 7000
VN 8900 ZM 8360 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
Front cover; Contents; List of Figures; List of Tables; About the Book; Preface; Acknowledgments; Authors; Introduction; Disclaimer; CLV-1: How to Establish a Cleaning Validation Program; Body; CLV-2: Introduction; CLV-3: Scope and Approach; CLV-4: Cleaning Validation Team Membersand Responsibilities; CLV-5: Cleaning Validation Philosophy, Strategies,and Methodology; CLV-6: Planning Phase; CLV-7: Execution Phase; CLV-8: Analytical Testing and Reporting Phase; CLV-9: Equipment Description; CLV-10: Facility Description; CLV-11: Utilities Description: DIW, WFI, Steam,and Compressed Air
CLV-12: Utilities Monitoring and Microbiological ControlCLV-13: Equipment Cleaning Materials/DetergentDescription; CLV-14: Microbiological Cleaning of Equipment Surface; CLV-15: Solubility of Active Materials in Water; CLV-16: Toxicity of Active Materials; CLV-17: Cleaning Validation Products Grouping Matrix (Tablets, Capsules, and PPS); CLV-18: Product/Equipment Train Matrix (Tab-Cap-PPS); CLV-19: Worst-Case Products (Tablets, Capsules,and PPS) Matrix; CLV-20: Validation with Corresponding Cleaning Procedures; CLV-20.1: Cleaning Validation Protocol for Fluid Bed Dryer CLV-20.2: Cleaning Validation Protocol for MixerCLV-20.3: Cleaning Validation Protocol for Granulation Machines (Type A); CLV-20.4: Cleaning Validation Protocol for Powder Bins; CLV-20.5: Cleaning Validation Protocol for Tablet Press; CLV-20.6: Cleaning Validation Protocol for Sieve; CLV-20.7: Cleaning Validation Protocol for Powder-Filling Machine; CLV-20.8: Cleaning Validation Protocol for Encapsulation Machine; CLV-20.9: Cleaning Validation Protocol for Film-Coating Pan; CLV-20.10: Cleaning Validation Protocol for Sugar-Coating Pan CLV-21: Cleaning Validation Product Grouping Matrix (Syrup)CLV-22: Cleaning Validation Product/Equipment Train (Syrup); CLV-23: Worst-Case Products (Syrup; CLV-24: Cleaning Validation Product Grouping Matrix (Suspension); CLV-25: Product Grouping/Equipment Train Matrix (Suspension); CLV-26: Worst-Case Products (Suspension); CLV-27: Product Grouping Matrix (Drops); CLV-28: Product/Equipment Train (Drops); CLV-29: Worst-Case Products (Drops); CLV-30: Cleaning Validation Product Grouping Matrix (Cream/Ointment); CLV-31: Product/Equipment Train (Cream and Ointment) CLV-32: Worst-Case Products (Ointment and Cream)CLV-33: Product Grouping Matrix (Suppositories); CLV-34: Cleaning Validation Product/Equipment Train (Suppositories); CLV-35: Worst-Case Products (Suppositories); CLV-36: Cleaning Validation Protocols Products (Suppositories); CLV-36.1 Protocol for Manufacturing Vessel; CLV-36.2 Protocol for Bin-Washing Station; CLV-36.3 Cleaning Validation Protocol for Syrup-Holding Tank; CLV-36.4: Protocol for Filling Station and Filter Assembly; CLV-37: Cleaning Validation Product Grouping Matrix (Sterile) CLV-38 Cleaning Validation Product/Equipment Train Matrix (Sterile) |
Record Nr. | UNINA-9910792699603321 |
Haider Syed Imtiaz | ||
Boca Raton : , : CRC Press, , 2010 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Cleaning validation manual : a comprehensive guide for the pharmaceutical and biotechnology industries / / Syed Imtiaz Haider, Erfan Syed Asif |
Autore | Haider Syed Imtiaz |
Pubbl/distr/stampa | Boca Raton : , : CRC Press, , 2010 |
Descrizione fisica | 1 online resource (610 p.) |
Disciplina | 615/.19 |
Altri autori (Persone) | AsifErfan Syed |
Soggetto topico |
Pharmaceutical industry - Equipment and supplies - Sterilization
Drug factories - Cleaning |
ISBN |
0-429-15225-6
1-4398-2661-7 |
Classificazione |
VN 7000
VN 8900 ZM 8360 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
Front cover; Contents; List of Figures; List of Tables; About the Book; Preface; Acknowledgments; Authors; Introduction; Disclaimer; CLV-1: How to Establish a Cleaning Validation Program; Body; CLV-2: Introduction; CLV-3: Scope and Approach; CLV-4: Cleaning Validation Team Membersand Responsibilities; CLV-5: Cleaning Validation Philosophy, Strategies,and Methodology; CLV-6: Planning Phase; CLV-7: Execution Phase; CLV-8: Analytical Testing and Reporting Phase; CLV-9: Equipment Description; CLV-10: Facility Description; CLV-11: Utilities Description: DIW, WFI, Steam,and Compressed Air
CLV-12: Utilities Monitoring and Microbiological ControlCLV-13: Equipment Cleaning Materials/DetergentDescription; CLV-14: Microbiological Cleaning of Equipment Surface; CLV-15: Solubility of Active Materials in Water; CLV-16: Toxicity of Active Materials; CLV-17: Cleaning Validation Products Grouping Matrix (Tablets, Capsules, and PPS); CLV-18: Product/Equipment Train Matrix (Tab-Cap-PPS); CLV-19: Worst-Case Products (Tablets, Capsules,and PPS) Matrix; CLV-20: Validation with Corresponding Cleaning Procedures; CLV-20.1: Cleaning Validation Protocol for Fluid Bed Dryer CLV-20.2: Cleaning Validation Protocol for MixerCLV-20.3: Cleaning Validation Protocol for Granulation Machines (Type A); CLV-20.4: Cleaning Validation Protocol for Powder Bins; CLV-20.5: Cleaning Validation Protocol for Tablet Press; CLV-20.6: Cleaning Validation Protocol for Sieve; CLV-20.7: Cleaning Validation Protocol for Powder-Filling Machine; CLV-20.8: Cleaning Validation Protocol for Encapsulation Machine; CLV-20.9: Cleaning Validation Protocol for Film-Coating Pan; CLV-20.10: Cleaning Validation Protocol for Sugar-Coating Pan CLV-21: Cleaning Validation Product Grouping Matrix (Syrup)CLV-22: Cleaning Validation Product/Equipment Train (Syrup); CLV-23: Worst-Case Products (Syrup; CLV-24: Cleaning Validation Product Grouping Matrix (Suspension); CLV-25: Product Grouping/Equipment Train Matrix (Suspension); CLV-26: Worst-Case Products (Suspension); CLV-27: Product Grouping Matrix (Drops); CLV-28: Product/Equipment Train (Drops); CLV-29: Worst-Case Products (Drops); CLV-30: Cleaning Validation Product Grouping Matrix (Cream/Ointment); CLV-31: Product/Equipment Train (Cream and Ointment) CLV-32: Worst-Case Products (Ointment and Cream)CLV-33: Product Grouping Matrix (Suppositories); CLV-34: Cleaning Validation Product/Equipment Train (Suppositories); CLV-35: Worst-Case Products (Suppositories); CLV-36: Cleaning Validation Protocols Products (Suppositories); CLV-36.1 Protocol for Manufacturing Vessel; CLV-36.2 Protocol for Bin-Washing Station; CLV-36.3 Cleaning Validation Protocol for Syrup-Holding Tank; CLV-36.4: Protocol for Filling Station and Filter Assembly; CLV-37: Cleaning Validation Product Grouping Matrix (Sterile) CLV-38 Cleaning Validation Product/Equipment Train Matrix (Sterile) |
Record Nr. | UNINA-9910818795703321 |
Haider Syed Imtiaz | ||
Boca Raton : , : CRC Press, , 2010 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Clinical chemistry research [[electronic resource] /] / Brian H. Mitchem and Charles L. Sharnham, editors |
Pubbl/distr/stampa | New York, : Nova Biomedical, c2009 |
Descrizione fisica | 1 online resource (392 p.) |
Disciplina | 615/.19 |
Altri autori (Persone) |
MitchemBrian H
SharnhamCharles L |
Soggetto topico |
Pharmaceutical chemistry
Clinical chemistry Clinical biochemistry |
Soggetto genere / forma | Electronic books. |
ISBN | 1-61209-884-3 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Record Nr. | UNINA-9910465210003321 |
New York, : Nova Biomedical, c2009 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Clinical chemistry research [[electronic resource] /] / Brian H. Mitchem and Charles L. Sharnham, editors |
Pubbl/distr/stampa | New York : , : Nova Biomedical, , 2009 |
Descrizione fisica | 1 online resource (xiv, 376 pages) : illustrations |
Disciplina | 615/.19 |
Altri autori (Persone) |
MitchemBrian H
SharnhamCharles L |
Soggetto topico |
Pharmaceutical chemistry
Clinical chemistry Clinical biochemistry |
ISBN | 1-61209-884-3 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Phytoestrogens : biochemical aspects and biological activities / Rita de Cassia da Silveira e Sá and Luciana Valente Borges -- (Q)SAR and clinical chemistry of camptothecin analogues / Rajeshwar P. Verma and Corwin Hansch -- Application of lanthanide (Ln= Eu & Tb) nanoparticles in biology and medicine / Chittaranjan Patra, Priyabrata Mukherjee, and Debabrata Mukhopadhyay -- Identification and analysis of effective components in animal biofluids following administration of natural medicines / Chenggang Huang ... [et al.] -- Frontiers of molecular technologies in noninvasive prenatal diagnosis / Sherry Sze Yee Ho ... [et al.] -- Polymeric nanoparticles as carrier systems : how does the material and surface charge affect cellular uptake / Anna Musyanovych, Katharina Landfester, and Volker Mailänder -- The role of 1, 25 dihydroxy-vitamin D3 in immunity to infectious disease / Michael Eisenhut -- Generation and analysis of disease-specific mouse models by clinical chemical screening / Bernhard Aigner, Birgit Rathkolb, Eckhard Wolf -- Gene therapy of congenital diseases : applications, problems, and prospects / Jixin Yang and Jiexiong Feng -- Porphyrazine anti-tumor agents / B. J. Vesper ... [et al.] -- Mass spectrometry in clinical chemistry / Simone König -- Quantitative proteome-disease relationships (QPDRS) in clinical chemistry : prediction of prostate cancer with spectral moments of PSA/MS star networks / Giulio Ferino ... [et al.] -- Not so innocent : adipocytes may explain racial differences in breast cancer : implications for clinical chemistry / Francis O. Ikpatt, Errol Berman, and Arpad Szallasi -- Analytical method of allantoin detection in human sera and the clinical significance of this measurement / Haruhiro Muratsubaki and Keiichiro Enomoto -- Relationship between creatine kinase activity and serum aminotransferase activity in patients with extensive rhabdomyolysis or myocardial necrosis / Nadia Habal and Mark Feldman. |
Record Nr. | UNINA-9910791816703321 |
New York : , : Nova Biomedical, , 2009 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Clinical chemistry research [[electronic resource] /] / Brian H. Mitchem and Charles L. Sharnham, editors |
Pubbl/distr/stampa | New York : , : Nova Biomedical, , 2009 |
Descrizione fisica | 1 online resource (xiv, 376 pages) : illustrations |
Disciplina | 615/.19 |
Altri autori (Persone) |
MitchemBrian H
SharnhamCharles L |
Soggetto topico |
Pharmaceutical chemistry
Clinical chemistry Clinical biochemistry |
ISBN | 1-61209-884-3 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Phytoestrogens : biochemical aspects and biological activities / Rita de Cassia da Silveira e Sá and Luciana Valente Borges -- (Q)SAR and clinical chemistry of camptothecin analogues / Rajeshwar P. Verma and Corwin Hansch -- Application of lanthanide (Ln= Eu & Tb) nanoparticles in biology and medicine / Chittaranjan Patra, Priyabrata Mukherjee, and Debabrata Mukhopadhyay -- Identification and analysis of effective components in animal biofluids following administration of natural medicines / Chenggang Huang ... [et al.] -- Frontiers of molecular technologies in noninvasive prenatal diagnosis / Sherry Sze Yee Ho ... [et al.] -- Polymeric nanoparticles as carrier systems : how does the material and surface charge affect cellular uptake / Anna Musyanovych, Katharina Landfester, and Volker Mailänder -- The role of 1, 25 dihydroxy-vitamin D3 in immunity to infectious disease / Michael Eisenhut -- Generation and analysis of disease-specific mouse models by clinical chemical screening / Bernhard Aigner, Birgit Rathkolb, Eckhard Wolf -- Gene therapy of congenital diseases : applications, problems, and prospects / Jixin Yang and Jiexiong Feng -- Porphyrazine anti-tumor agents / B. J. Vesper ... [et al.] -- Mass spectrometry in clinical chemistry / Simone König -- Quantitative proteome-disease relationships (QPDRS) in clinical chemistry : prediction of prostate cancer with spectral moments of PSA/MS star networks / Giulio Ferino ... [et al.] -- Not so innocent : adipocytes may explain racial differences in breast cancer : implications for clinical chemistry / Francis O. Ikpatt, Errol Berman, and Arpad Szallasi -- Analytical method of allantoin detection in human sera and the clinical significance of this measurement / Haruhiro Muratsubaki and Keiichiro Enomoto -- Relationship between creatine kinase activity and serum aminotransferase activity in patients with extensive rhabdomyolysis or myocardial necrosis / Nadia Habal and Mark Feldman. |
Record Nr. | UNINA-9910813248403321 |
New York : , : Nova Biomedical, , 2009 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
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 | ||
|