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Titre : Analytical Testing for the Pharmaceutical GMP Laboratory Type de document : texte imprimé Auteurs : Kim Huynh-Ba, Auteur Editeur : Hoboken : Wiley Année de publication : 2022 Importance : 386p. Présentation : ill en couleurs Format : 24x16cm. ISBN/ISSN/EAN : 978-1-119-68043-7 Langues : Anglais (eng) Mots-clés : Analytical Pharmaceutical Index. décimale : 543-12.1 Résumé : Analytical Testing for the Pharmaceutical GMP Laboratory presents a
thorough overview of the pharmaceutical regulations, working processes, and
drug development best practices used to maintain the quality and integrity
of medicines. With a focus on smaller molecular weight drug substances and
products, the book provides the knowledge necessary for establishing the
pharmaceutical laboratory to support Quality Systems while maintaining
compliance with Good Manufacturing Practices (GMP) regulations.
Concise yet comprehensive chapters contain up-to-date coverage of drug
regulations, pharmaceutical analysis methodologies, control strategies,
testing development and validation, method transfer, electronic data
documentation, and more. Each chapter includes a table of contents,
definitions of acronyms, a reference list, and ample tables and figures.
Addressing the principal activities and regulatory challenges of analytical
testing in the development and manufacturing of pharmaceutical drug products,
this authoritative
resource:
Describes the structure, roles, core guidelines, and GMP regulations of the
FDA and ICH.
Covers the common analytical technologies used in pharmaceutical
laboratories, including examples of analytical techniques used for the
release and stability testing of drugs.
Examines control strategies established from quality systems supported by
real-world case studies.
Explains the use of dissolution testing for products such as
extended-release capsules, aerosols, and inhalers.
Discusses good documentation and data reporting practices, stability
programs, and the Laboratory Information Management System (LIMS) to
maintain compliance.
Includes calculations, application examples, and illustrations to assist
readers in day-to-day laboratory operations.
Contains practical information and templates to structure internal processes
or common Standard Operating Procedures (SOPs).
Analytical Testing for the Pharmaceutical GMP Laboratory is a must-have
reference for both early-career and experienced pharmaceutical scientists,
analytical chemists, pharmacists, and quality control professionals. It is
also both a resource for GMP laboratory training programs and an excellent
textbook for undergraduate and graduate courses of analytical chemistry in
pharmaceutical sciences or regulatory compliance programs.
Note de contenu : figures;index Analytical Testing for the Pharmaceutical GMP Laboratory [texte imprimé] / Kim Huynh-Ba, Auteur . - [S.l.] : Hoboken : Wiley, 2022 . - 386p. : ill en couleurs ; 24x16cm.
ISBN : 978-1-119-68043-7
Langues : Anglais (eng)
Mots-clés : Analytical Pharmaceutical Index. décimale : 543-12.1 Résumé : Analytical Testing for the Pharmaceutical GMP Laboratory presents a
thorough overview of the pharmaceutical regulations, working processes, and
drug development best practices used to maintain the quality and integrity
of medicines. With a focus on smaller molecular weight drug substances and
products, the book provides the knowledge necessary for establishing the
pharmaceutical laboratory to support Quality Systems while maintaining
compliance with Good Manufacturing Practices (GMP) regulations.
Concise yet comprehensive chapters contain up-to-date coverage of drug
regulations, pharmaceutical analysis methodologies, control strategies,
testing development and validation, method transfer, electronic data
documentation, and more. Each chapter includes a table of contents,
definitions of acronyms, a reference list, and ample tables and figures.
Addressing the principal activities and regulatory challenges of analytical
testing in the development and manufacturing of pharmaceutical drug products,
this authoritative
resource:
Describes the structure, roles, core guidelines, and GMP regulations of the
FDA and ICH.
Covers the common analytical technologies used in pharmaceutical
laboratories, including examples of analytical techniques used for the
release and stability testing of drugs.
Examines control strategies established from quality systems supported by
real-world case studies.
Explains the use of dissolution testing for products such as
extended-release capsules, aerosols, and inhalers.
Discusses good documentation and data reporting practices, stability
programs, and the Laboratory Information Management System (LIMS) to
maintain compliance.
Includes calculations, application examples, and illustrations to assist
readers in day-to-day laboratory operations.
Contains practical information and templates to structure internal processes
or common Standard Operating Procedures (SOPs).
Analytical Testing for the Pharmaceutical GMP Laboratory is a must-have
reference for both early-career and experienced pharmaceutical scientists,
analytical chemists, pharmacists, and quality control professionals. It is
also both a resource for GMP laboratory training programs and an excellent
textbook for undergraduate and graduate courses of analytical chemistry in
pharmaceutical sciences or regulatory compliance programs.
Note de contenu : figures;index Exemplaires (1)
Code-barres Cote Support Localisation Section Disponibilité F.M:15318 543-12.1 Ouvrage Faculté de Médecine 500 - Sciences de la nature et Mathématiques Exclu du prêt
Titre : Analytical Testing for the Pharmaceutical GMP Laboratory Type de document : texte imprimé Auteurs : Kim Huynh-Ba, Auteur Editeur : Hoboken : Wiley Année de publication : 2022 Importance : 386p. Présentation : ill en couleurs Format : 24x16cm. ISBN/ISSN/EAN : 978-1-119-68043-7 Langues : Anglais (eng) Mots-clés : Analytical Pharmaceutical Index. décimale : 543-12.1 Résumé : Analytical Testing for the Pharmaceutical GMP Laboratory presents a
thorough overview of the pharmaceutical regulations, working processes, and
drug development best practices used to maintain the quality and integrity
of medicines. With a focus on smaller molecular weight drug substances and
products, the book provides the knowledge necessary for establishing the
pharmaceutical laboratory to support Quality Systems while maintaining
compliance with Good Manufacturing Practices (GMP) regulations.
Concise yet comprehensive chapters contain up-to-date coverage of drug
regulations, pharmaceutical analysis methodologies, control strategies,
testing development and validation, method transfer, electronic data
documentation, and more. Each chapter includes a table of contents,
definitions of acronyms, a reference list, and ample tables and figures.
Addressing the principal activities and regulatory challenges of analytical
testing in the development and manufacturing of pharmaceutical drug products,
this authoritative
resource:
Describes the structure, roles, core guidelines, and GMP regulations of the
FDA and ICH.
Covers the common analytical technologies used in pharmaceutical
laboratories, including examples of analytical techniques used for the
release and stability testing of drugs.
Examines control strategies established from quality systems supported by
real-world case studies.
Explains the use of dissolution testing for products such as
extended-release capsules, aerosols, and inhalers.
Discusses good documentation and data reporting practices, stability
programs, and the Laboratory Information Management System (LIMS) to
maintain compliance.
Includes calculations, application examples, and illustrations to assist
readers in day-to-day laboratory operations.
Contains practical information and templates to structure internal processes
or common Standard Operating Procedures (SOPs).
Analytical Testing for the Pharmaceutical GMP Laboratory is a must-have
reference for both early-career and experienced pharmaceutical scientists,
analytical chemists, pharmacists, and quality control professionals. It is
also both a resource for GMP laboratory training programs and an excellent
textbook for undergraduate and graduate courses of analytical chemistry in
pharmaceutical sciences or regulatory compliance programs.
Note de contenu : figures;index Analytical Testing for the Pharmaceutical GMP Laboratory [texte imprimé] / Kim Huynh-Ba, Auteur . - [S.l.] : Hoboken : Wiley, 2022 . - 386p. : ill en couleurs ; 24x16cm.
ISBN : 978-1-119-68043-7
Langues : Anglais (eng)
Mots-clés : Analytical Pharmaceutical Index. décimale : 543-12.1 Résumé : Analytical Testing for the Pharmaceutical GMP Laboratory presents a
thorough overview of the pharmaceutical regulations, working processes, and
drug development best practices used to maintain the quality and integrity
of medicines. With a focus on smaller molecular weight drug substances and
products, the book provides the knowledge necessary for establishing the
pharmaceutical laboratory to support Quality Systems while maintaining
compliance with Good Manufacturing Practices (GMP) regulations.
Concise yet comprehensive chapters contain up-to-date coverage of drug
regulations, pharmaceutical analysis methodologies, control strategies,
testing development and validation, method transfer, electronic data
documentation, and more. Each chapter includes a table of contents,
definitions of acronyms, a reference list, and ample tables and figures.
Addressing the principal activities and regulatory challenges of analytical
testing in the development and manufacturing of pharmaceutical drug products,
this authoritative
resource:
Describes the structure, roles, core guidelines, and GMP regulations of the
FDA and ICH.
Covers the common analytical technologies used in pharmaceutical
laboratories, including examples of analytical techniques used for the
release and stability testing of drugs.
Examines control strategies established from quality systems supported by
real-world case studies.
Explains the use of dissolution testing for products such as
extended-release capsules, aerosols, and inhalers.
Discusses good documentation and data reporting practices, stability
programs, and the Laboratory Information Management System (LIMS) to
maintain compliance.
Includes calculations, application examples, and illustrations to assist
readers in day-to-day laboratory operations.
Contains practical information and templates to structure internal processes
or common Standard Operating Procedures (SOPs).
Analytical Testing for the Pharmaceutical GMP Laboratory is a must-have
reference for both early-career and experienced pharmaceutical scientists,
analytical chemists, pharmacists, and quality control professionals. It is
also both a resource for GMP laboratory training programs and an excellent
textbook for undergraduate and graduate courses of analytical chemistry in
pharmaceutical sciences or regulatory compliance programs.
Note de contenu : figures;index Exemplaires
Code-barres Cote Support Localisation Section Disponibilité aucun exemplaire
Titre : Chemical Analysis : Modern Instrumentation Methods and Techniques Type de document : texte imprimé Auteurs : Rouessac Francis, Auteur ; Annick Rouessac, Auteur ; John Towey, Traducteur Mention d'édition : 3 édition Editeur : Hoboken : Wiley Année de publication : 2021 Importance : 613p. Présentation : ill en couleurs Format : 24x16cm. ISBN/ISSN/EAN : 978-1-119-70134-7 Langues : Anglais (eng) Mots-clés : Chemical Analysis Index. décimale : 543-11.1 Résumé : The new edition of the popular introductory analytical chemistry
textbook, providing students with a solid foundation in all the major
instrumental analysis techniques currently in
use
The third edition of Chemical Analysis: Modern Instrumentation Methods and
Techniques provides an up-to-date overview of the common methods used for
qualitative, quantitative, and structural chemical analysis. Assuming no
background knowledge in the subject, this student-friendly textbook covers
the fundamental principles and practical aspects of more than 20 separation
and spectroscopic methods, as well as other important techniques such as
elemental analysis, electrochemistry and isotopic labelling methods.
Avoiding technical complexity and theoretical depth, clear and accessible
chapters explain the basic concepts of each method and its corresponding
instrumental techniques--supported by explanatory diagrams, illustrations,
and photographs of commercial instruments. The new edition includes revised
coverage of recent developments in supercritical fluid chromatography,
capillary electrophoresis, miniaturized sensors, automatic analyzers,
digitization and computing power, and more. Offering a well-balanced
introduction to a wide range of analytical and instrumentation techniques,
this
textbook:
Provides a detailed overview of analysis methods used in the chemical and
agri-food industries, medical analysis laboratories, and environmental
sciencesCovers various separation methods including chromatography,
electrophoresis and
electrochromatographyDescribes UV and infrared spectroscopy, fluorimetry and
chemiluminescence, x-ray fluorescence, nuclear magnetic resonance and other
common spectrometric methods such atomic or flame emission, atomic
absorption and mass
spectrometryIncludes concise overview chapters on the general aspects of
chromatography, sample preparation strategies, and basic statistical
parametersFeatures examples, end-of-chapter problems with solutions, and a
companion website featuring PowerPoint slides for
instructorsChemical Analysis: Modern Instrumentation Methods and Techniques,
Third Edition, is the perfect textbook for undergraduates taking
introductory courses in instrumental analytical chemistry, students in
chemistry, pharmacy, biochemistry, and environmental science programs
looking for information on the techniques and instruments available, and
industry technicians working with problems of chemical analysis.
Review of Second
Edition
"An essential introduction to a wide range of analytical and instrumentation
techniques that have been developed and improved in recent years.
"
--International Journal of Environmental and Analytical Chemistry
Note de contenu : figures;index Chemical Analysis : Modern Instrumentation Methods and Techniques [texte imprimé] / Rouessac Francis, Auteur ; Annick Rouessac, Auteur ; John Towey, Traducteur . - 3 édition . - [S.l.] : Hoboken : Wiley, 2021 . - 613p. : ill en couleurs ; 24x16cm.
ISBN : 978-1-119-70134-7
Langues : Anglais (eng)
Mots-clés : Chemical Analysis Index. décimale : 543-11.1 Résumé : The new edition of the popular introductory analytical chemistry
textbook, providing students with a solid foundation in all the major
instrumental analysis techniques currently in
use
The third edition of Chemical Analysis: Modern Instrumentation Methods and
Techniques provides an up-to-date overview of the common methods used for
qualitative, quantitative, and structural chemical analysis. Assuming no
background knowledge in the subject, this student-friendly textbook covers
the fundamental principles and practical aspects of more than 20 separation
and spectroscopic methods, as well as other important techniques such as
elemental analysis, electrochemistry and isotopic labelling methods.
Avoiding technical complexity and theoretical depth, clear and accessible
chapters explain the basic concepts of each method and its corresponding
instrumental techniques--supported by explanatory diagrams, illustrations,
and photographs of commercial instruments. The new edition includes revised
coverage of recent developments in supercritical fluid chromatography,
capillary electrophoresis, miniaturized sensors, automatic analyzers,
digitization and computing power, and more. Offering a well-balanced
introduction to a wide range of analytical and instrumentation techniques,
this
textbook:
Provides a detailed overview of analysis methods used in the chemical and
agri-food industries, medical analysis laboratories, and environmental
sciencesCovers various separation methods including chromatography,
electrophoresis and
electrochromatographyDescribes UV and infrared spectroscopy, fluorimetry and
chemiluminescence, x-ray fluorescence, nuclear magnetic resonance and other
common spectrometric methods such atomic or flame emission, atomic
absorption and mass
spectrometryIncludes concise overview chapters on the general aspects of
chromatography, sample preparation strategies, and basic statistical
parametersFeatures examples, end-of-chapter problems with solutions, and a
companion website featuring PowerPoint slides for
instructorsChemical Analysis: Modern Instrumentation Methods and Techniques,
Third Edition, is the perfect textbook for undergraduates taking
introductory courses in instrumental analytical chemistry, students in
chemistry, pharmacy, biochemistry, and environmental science programs
looking for information on the techniques and instruments available, and
industry technicians working with problems of chemical analysis.
Review of Second
Edition
"An essential introduction to a wide range of analytical and instrumentation
techniques that have been developed and improved in recent years.
"
--International Journal of Environmental and Analytical Chemistry
Note de contenu : figures;index Exemplaires (1)
Code-barres Cote Support Localisation Section Disponibilité F.M:15317 543-11.1 Ouvrage Faculté de Médecine 500 - Sciences de la nature et Mathématiques Exclu du prêt
Titre : Handbook of Pediatric Hematology and Oncology : Children's Hospital and Research Center Oakland Type de document : texte imprimé Auteurs : Hastings Caroline A., Auteur ; Joseph C. Torkildson, Auteur ; Anurag K. Agrawal, Auteur Mention d'édition : 3 édition Editeur : Hoboken : Wiley Année de publication : 2021 Importance : 499p. : Présentation : ill en couleurs Format : 24x16cm. ISBN/ISSN/EAN : 978-1-119-21074-0 Langues : Anglais (eng) Mots-clés : Pediatric Hematology Oncology Index. décimale : 618.3-84.1 Résumé : The revised guide to the diagnosis, management, and treatment of blood
disorders and cancer in
children
Children with blood disorders and cancer are a unique population that
require specialized diagnostic considerations and management. The Handbook
of Pediatric Hematology and Oncology has been designed to provide clinicians
of all levels with practical guidance through an up-to-date algorithmic
approach to these conditions. Assembled by a team of experts from the
world-class Children's Hospital & Research Center Oakland, this updated
third
edition:
Presents up-to-date management and treatment guidelines for the most common
pediatric blood disorders and
malignanciesProvides an updated algorithmic approach for the diagnosis and
management of the most common conditions and suggested
readingsUtilizes rapid-referral tables containing visual representations of
symptoms, lab findings, differentials, and treatment
guidanceIncorporates case studies covering different hematologic and
oncologic conditions, such as hemolytic anemia, sickle cell disease,
hemophilia, neuroblastoma, and sarcomas of the soft tissue and
boneIncludes a useful formulary that lists chemotherapy agents, dosing,
mechanism of action, pregnancy category, indications, and side
effectsCovers transfusion medicine, stem cell transplantation, management of
central venous catheters, acute pain management, oncologic emergencies, and
chemotherapy
basicsWith its direct guidance and portable design, the Handbook of
Pediatric Hematology and Oncology: Children's Hospital & Research Center
Oakland, Third Edition, will prove an invaluable resource to medical
students, trainees and residents, pediatric hematology and oncology nurses,
pediatricians, and early-career providers in pediatric hematology/oncology.
Note de contenu : figures;index Handbook of Pediatric Hematology and Oncology : Children's Hospital and Research Center Oakland [texte imprimé] / Hastings Caroline A., Auteur ; Joseph C. Torkildson, Auteur ; Anurag K. Agrawal, Auteur . - 3 édition . - [S.l.] : Hoboken : Wiley, 2021 . - 499p. : : ill en couleurs ; 24x16cm.
ISBN : 978-1-119-21074-0
Langues : Anglais (eng)
Mots-clés : Pediatric Hematology Oncology Index. décimale : 618.3-84.1 Résumé : The revised guide to the diagnosis, management, and treatment of blood
disorders and cancer in
children
Children with blood disorders and cancer are a unique population that
require specialized diagnostic considerations and management. The Handbook
of Pediatric Hematology and Oncology has been designed to provide clinicians
of all levels with practical guidance through an up-to-date algorithmic
approach to these conditions. Assembled by a team of experts from the
world-class Children's Hospital & Research Center Oakland, this updated
third
edition:
Presents up-to-date management and treatment guidelines for the most common
pediatric blood disorders and
malignanciesProvides an updated algorithmic approach for the diagnosis and
management of the most common conditions and suggested
readingsUtilizes rapid-referral tables containing visual representations of
symptoms, lab findings, differentials, and treatment
guidanceIncorporates case studies covering different hematologic and
oncologic conditions, such as hemolytic anemia, sickle cell disease,
hemophilia, neuroblastoma, and sarcomas of the soft tissue and
boneIncludes a useful formulary that lists chemotherapy agents, dosing,
mechanism of action, pregnancy category, indications, and side
effectsCovers transfusion medicine, stem cell transplantation, management of
central venous catheters, acute pain management, oncologic emergencies, and
chemotherapy
basicsWith its direct guidance and portable design, the Handbook of
Pediatric Hematology and Oncology: Children's Hospital & Research Center
Oakland, Third Edition, will prove an invaluable resource to medical
students, trainees and residents, pediatric hematology and oncology nurses,
pediatricians, and early-career providers in pediatric hematology/oncology.
Note de contenu : figures;index Exemplaires (1)
Code-barres Cote Support Localisation Section Disponibilité F.M:15362 618.3-84.1 Ouvrage Faculté de Médecine 600 - Technologie (Sciences appliquées) Exclu du prêt
Titre : Handbook of Pediatric Hematology and Oncology : Children's Hospital and Research Center Oakland Type de document : texte imprimé Auteurs : Hastings Caroline A., Auteur ; Joseph C. Torkildson, Auteur ; Anurag K. Agrawal, Auteur Mention d'édition : 3 édition Editeur : Hoboken : Wiley Année de publication : 2021 Importance : 499p. : Présentation : ill en couleurs Format : 24x16cm. ISBN/ISSN/EAN : 978-1-119-21074-0 Langues : Anglais (eng) Mots-clés : Pediatric Hematology Oncology Index. décimale : 618.3-84.1 Résumé : The revised guide to the diagnosis, management, and treatment of blood
disorders and cancer in
children
Children with blood disorders and cancer are a unique population that
require specialized diagnostic considerations and management. The Handbook
of Pediatric Hematology and Oncology has been designed to provide clinicians
of all levels with practical guidance through an up-to-date algorithmic
approach to these conditions. Assembled by a team of experts from the
world-class Children's Hospital & Research Center Oakland, this updated
third
edition:
Presents up-to-date management and treatment guidelines for the most common
pediatric blood disorders and
malignanciesProvides an updated algorithmic approach for the diagnosis and
management of the most common conditions and suggested
readingsUtilizes rapid-referral tables containing visual representations of
symptoms, lab findings, differentials, and treatment
guidanceIncorporates case studies covering different hematologic and
oncologic conditions, such as hemolytic anemia, sickle cell disease,
hemophilia, neuroblastoma, and sarcomas of the soft tissue and
boneIncludes a useful formulary that lists chemotherapy agents, dosing,
mechanism of action, pregnancy category, indications, and side
effectsCovers transfusion medicine, stem cell transplantation, management of
central venous catheters, acute pain management, oncologic emergencies, and
chemotherapy
basicsWith its direct guidance and portable design, the Handbook of
Pediatric Hematology and Oncology: Children's Hospital & Research Center
Oakland, Third Edition, will prove an invaluable resource to medical
students, trainees and residents, pediatric hematology and oncology nurses,
pediatricians, and early-career providers in pediatric hematology/oncology.
Note de contenu : figures;index Handbook of Pediatric Hematology and Oncology : Children's Hospital and Research Center Oakland [texte imprimé] / Hastings Caroline A., Auteur ; Joseph C. Torkildson, Auteur ; Anurag K. Agrawal, Auteur . - 3 édition . - [S.l.] : Hoboken : Wiley, 2021 . - 499p. : : ill en couleurs ; 24x16cm.
ISBN : 978-1-119-21074-0
Langues : Anglais (eng)
Mots-clés : Pediatric Hematology Oncology Index. décimale : 618.3-84.1 Résumé : The revised guide to the diagnosis, management, and treatment of blood
disorders and cancer in
children
Children with blood disorders and cancer are a unique population that
require specialized diagnostic considerations and management. The Handbook
of Pediatric Hematology and Oncology has been designed to provide clinicians
of all levels with practical guidance through an up-to-date algorithmic
approach to these conditions. Assembled by a team of experts from the
world-class Children's Hospital & Research Center Oakland, this updated
third
edition:
Presents up-to-date management and treatment guidelines for the most common
pediatric blood disorders and
malignanciesProvides an updated algorithmic approach for the diagnosis and
management of the most common conditions and suggested
readingsUtilizes rapid-referral tables containing visual representations of
symptoms, lab findings, differentials, and treatment
guidanceIncorporates case studies covering different hematologic and
oncologic conditions, such as hemolytic anemia, sickle cell disease,
hemophilia, neuroblastoma, and sarcomas of the soft tissue and
boneIncludes a useful formulary that lists chemotherapy agents, dosing,
mechanism of action, pregnancy category, indications, and side
effectsCovers transfusion medicine, stem cell transplantation, management of
central venous catheters, acute pain management, oncologic emergencies, and
chemotherapy
basicsWith its direct guidance and portable design, the Handbook of
Pediatric Hematology and Oncology: Children's Hospital & Research Center
Oakland, Third Edition, will prove an invaluable resource to medical
students, trainees and residents, pediatric hematology and oncology nurses,
pediatricians, and early-career providers in pediatric hematology/oncology.
Note de contenu : figures;index Exemplaires
Code-barres Cote Support Localisation Section Disponibilité aucun exemplaire Permalink
