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Der zunehmende Druck des Gesetzgebers auf die pharmazeutische Industrie steigert die Nachfrage nach Fachkräften, die in Forschung, Entwicklung und Produktion zuverlässig und qualitätssicher arbeiten. Dieser Band ging aus dem einschlägigen Inhouse-Weiterbildungsprogramm von Johnson&Johnson hervor und zeigt dem Analytiker anschaulich, wie die GMP-Vorschriften der FDA im Alltag umzusetzen sind. Angesprochen werden alle wichtigen Analysenverfahren und Methoden, von der Spektroskopie über die Chromatographie bis zur Herstellung von Lösungen. Hervorragend auch zum Selbststudium geeignet! (09/00)
Der zunehmende Druck des Gesetzgebers auf die pharmazeutische Industrie steigert die Nachfrage nach Fachkräften, die in Forschung, Entwicklung und Produktion zuverlässig und qualitätssicher arbeiten. Dieser Band ging aus dem einschlägigen Inhouse-Weiterbildungsprogramm von Johnson&Johnson hervor und zeigt dem Analytiker anschaulich, wie die GMP-Vorschriften der FDA im Alltag umzusetzen sind. Angesprochen werden alle wichtigen Analysenverfahren und Methoden, von der Spektroskopie über die Chromatographie bis zur Herstellung von Lösungen. Hervorragend auch zum Selbststudium geeignet! (09/00)
Über den Autor
I love children of all ages, and love reading to children. It is such a joy watching them grow, not only physically, but socially and mentally as well. I have worked many years with children and have loved every minute. I am always amazed how fast they learn, and I love being a part of that learning process. I have worked in the classroom and in many summer camps for kids and teens, helping them build confidence and self-esteem to conquer their tasks. I have kids of my own that I have encouraged to succeed and be independent. I love seeing everyone succeed, especially in their courage, certainty, and self-esteem.I love sailing, photography, hiking, camping, scuba diving, motorcycle riding, and spending time with family. If it involves water, outdoors or family, then chances are I love it.
Inhaltsverzeichnis
The Laboratory Analyst's Role in the Drug Development Process (J. Crowther, et al.).
Laboratory Controls and Compliance (H. Avallone).
The USP, ICH, and Other Compendial Methods (J. Feldman).
Statistics in the Pharmaceutical Analysis Laboratory (A. Melveger).
Basic Analytical Operations and Solution Chemistry (N. Snow & W. Murphy).
Spectroscopy (P. Abauf & A. Melveger).
Chromatographic Principles (J. Miller).
Gas Chromatography (J. Miller & H. McNair).
Liquid Chromatography: Basic Overview (L. Polite).
HPLC Column Parameters (R. Hartwick).
Dissolution (R. Kirchhoefer & R. Peeters).
Analytical Method Development for Assay and Impurity Determination in Drug Substances and Drug Products (J. Crowther, et al.).
Some Principles of Quantitative Analysis (J. Miller).
Laboratory Data Systems (R. McDowall).
Qualification of Laboratory Instrumentation, Validation, and Transfer of Analytical Methods (J. Crowther, et al.).
Appendices.
Index.
Laboratory Controls and Compliance (H. Avallone).
The USP, ICH, and Other Compendial Methods (J. Feldman).
Statistics in the Pharmaceutical Analysis Laboratory (A. Melveger).
Basic Analytical Operations and Solution Chemistry (N. Snow & W. Murphy).
Spectroscopy (P. Abauf & A. Melveger).
Chromatographic Principles (J. Miller).
Gas Chromatography (J. Miller & H. McNair).
Liquid Chromatography: Basic Overview (L. Polite).
HPLC Column Parameters (R. Hartwick).
Dissolution (R. Kirchhoefer & R. Peeters).
Analytical Method Development for Assay and Impurity Determination in Drug Substances and Drug Products (J. Crowther, et al.).
Some Principles of Quantitative Analysis (J. Miller).
Laboratory Data Systems (R. McDowall).
Qualification of Laboratory Instrumentation, Validation, and Transfer of Analytical Methods (J. Crowther, et al.).
Appendices.
Index.
Details
Erscheinungsjahr: | 2000 |
---|---|
Fachbereich: | Theoretische Chemie |
Genre: | Chemie |
Rubrik: | Naturwissenschaften & Technik |
Medium: | Buch |
Inhalt: |
XXIV
488 S. |
ISBN-13: | 9780471314318 |
ISBN-10: | 0471314315 |
Sprache: | Englisch |
Einband: | Gebunden |
Redaktion: |
Miller, James M
Crowther, Jonathan B |
Herausgeber: | James M Miller/Jonathan B Crowther |
Hersteller: |
Wiley
John Wiley & Sons |
Maße: | 240 x 161 x 32 mm |
Von/Mit: | James M Miller (u. a.) |
Erscheinungsdatum: | 01.05.2000 |
Gewicht: | 0,933 kg |
Über den Autor
I love children of all ages, and love reading to children. It is such a joy watching them grow, not only physically, but socially and mentally as well. I have worked many years with children and have loved every minute. I am always amazed how fast they learn, and I love being a part of that learning process. I have worked in the classroom and in many summer camps for kids and teens, helping them build confidence and self-esteem to conquer their tasks. I have kids of my own that I have encouraged to succeed and be independent. I love seeing everyone succeed, especially in their courage, certainty, and self-esteem.I love sailing, photography, hiking, camping, scuba diving, motorcycle riding, and spending time with family. If it involves water, outdoors or family, then chances are I love it.
Inhaltsverzeichnis
The Laboratory Analyst's Role in the Drug Development Process (J. Crowther, et al.).
Laboratory Controls and Compliance (H. Avallone).
The USP, ICH, and Other Compendial Methods (J. Feldman).
Statistics in the Pharmaceutical Analysis Laboratory (A. Melveger).
Basic Analytical Operations and Solution Chemistry (N. Snow & W. Murphy).
Spectroscopy (P. Abauf & A. Melveger).
Chromatographic Principles (J. Miller).
Gas Chromatography (J. Miller & H. McNair).
Liquid Chromatography: Basic Overview (L. Polite).
HPLC Column Parameters (R. Hartwick).
Dissolution (R. Kirchhoefer & R. Peeters).
Analytical Method Development for Assay and Impurity Determination in Drug Substances and Drug Products (J. Crowther, et al.).
Some Principles of Quantitative Analysis (J. Miller).
Laboratory Data Systems (R. McDowall).
Qualification of Laboratory Instrumentation, Validation, and Transfer of Analytical Methods (J. Crowther, et al.).
Appendices.
Index.
Laboratory Controls and Compliance (H. Avallone).
The USP, ICH, and Other Compendial Methods (J. Feldman).
Statistics in the Pharmaceutical Analysis Laboratory (A. Melveger).
Basic Analytical Operations and Solution Chemistry (N. Snow & W. Murphy).
Spectroscopy (P. Abauf & A. Melveger).
Chromatographic Principles (J. Miller).
Gas Chromatography (J. Miller & H. McNair).
Liquid Chromatography: Basic Overview (L. Polite).
HPLC Column Parameters (R. Hartwick).
Dissolution (R. Kirchhoefer & R. Peeters).
Analytical Method Development for Assay and Impurity Determination in Drug Substances and Drug Products (J. Crowther, et al.).
Some Principles of Quantitative Analysis (J. Miller).
Laboratory Data Systems (R. McDowall).
Qualification of Laboratory Instrumentation, Validation, and Transfer of Analytical Methods (J. Crowther, et al.).
Appendices.
Index.
Details
Erscheinungsjahr: | 2000 |
---|---|
Fachbereich: | Theoretische Chemie |
Genre: | Chemie |
Rubrik: | Naturwissenschaften & Technik |
Medium: | Buch |
Inhalt: |
XXIV
488 S. |
ISBN-13: | 9780471314318 |
ISBN-10: | 0471314315 |
Sprache: | Englisch |
Einband: | Gebunden |
Redaktion: |
Miller, James M
Crowther, Jonathan B |
Herausgeber: | James M Miller/Jonathan B Crowther |
Hersteller: |
Wiley
John Wiley & Sons |
Maße: | 240 x 161 x 32 mm |
Von/Mit: | James M Miller (u. a.) |
Erscheinungsdatum: | 01.05.2000 |
Gewicht: | 0,933 kg |
Warnhinweis