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Chiral separation methods for pharmaceutical and biotechnological products [[electronic resource] /] / Satinder Ahuja
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
Opac: Controlla la disponibilità qui
Chiral separation methods for pharmaceutical and biotechnological products [[electronic resource] /] / Satinder Ahuja
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
Opac: Controlla la disponibilità qui
Chiral separation methods for pharmaceutical and biotechnological products [[electronic resource] /] / Satinder Ahuja
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
Opac: Controlla la disponibilità qui
Cleaning validation manual : a comprehensive guide for the pharmaceutical and biotechnology industries / / Syed Imtiaz Haider, Erfan Syed Asif
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
Opac: Controlla la disponibilità qui
Cleaning validation manual : a comprehensive guide for the pharmaceutical and biotechnology industries / / Syed Imtiaz Haider, Erfan Syed Asif
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
Opac: Controlla la disponibilità qui
Cleaning validation manual : a comprehensive guide for the pharmaceutical and biotechnology industries / / Syed Imtiaz Haider, Erfan Syed Asif
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
Opac: Controlla la disponibilità qui
Clinical chemistry research [[electronic resource] /] / Brian H. Mitchem and Charles L. Sharnham, editors
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
Opac: Controlla la disponibilità qui
Clinical chemistry research [[electronic resource] /] / Brian H. Mitchem and Charles L. Sharnham, editors
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
Opac: Controlla la disponibilità qui
Clinical chemistry research [[electronic resource] /] / Brian H. Mitchem and Charles L. Sharnham, editors
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
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
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
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