Michael E. Swartz – författare
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9 produkter
9 produkter
Häftad, Engelska, 1997
740 kr
Skickas inom 10-15 vardagar
Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.
Inbunden, Engelska, 2012
2 714 kr
Skickas inom 10-15 vardagar
Written for practitioners in both the drug and biotechnology industries, the Handbook of Analytical Validation carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, the handbook: Contains practical, up-to-date guidelines for analytical method validationSummarizes the latest regulatory requirements for all aspects of method validation, even those coming from the USP, but undergoing modificationsCovers development, optimization, validation, and transfer of many different types of methods used in the regulatory environmentSimplifying the overall process of method development, optimization and validation, the guidelines in the Handbook apply to both small molecules in the conventional pharmaceutical industry, as well as well as the biotech industry.
E-bok
Engelska, 20123 174 kr
Läs direkt efter köp
Written for practitioners in both the drug and biotechnology industries, this handbook carefully compiles the current regulatory requirements to correctly and properly validate a new or modified analytical method. The Handbook of Analytical Validation is designed to teach readers how to fully and correctly adapt new or modified analytical methods to meet regulatory requirements. The contents offer the latest regulatory requirements for submitting applications for new drugs or other applications, as regards analytical method validation. The chapters apply to both small molecules in the conventional pharmaceutical industry, as well the biotech industry.
Inbunden, Engelska, 2017
2 773 kr
Skickas inom 10-15 vardagar
Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.
E-bok
Engelska, 2018860 kr
Läs direkt efter köp
Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.
E-bok
PDF, Engelska, 2018860 kr
Läs direkt efter köp
Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.
Inbunden, Engelska, 2014
2 049 kr
Skickas inom 5-8 vardagar
Inbunden, Engelska, 2000
2 039 kr
Tillfälligt slut
This volume presents the necessary tools for developing methods and analyzing results in the drug discovery process, and supports documenting and managing the process in a combinatorial setting. It describes the chromatographic and spectroscopic techniques used to generate chemical and molecular diversity in new compounds, focusing on applications of information management systems, instrumentation, and robotics.
E-bok
Engelska, 20121 475 kr
Läs direkt efter köp
Written for practitioners in both the drug and biotechnology industries, this handbook carefully compiles the current regulatory requirements to correctly and properly validate a new or modified analytical method. The Handbook of Analytical Validation is designed to teach readers how to fully and correctly adapt new or modified analytical methods to meet regulatory requirements. The contents offer the latest regulatory requirements for submitting applications for new drugs or other applications, as regards analytical method validation. The chapters apply to both small molecules in the conventional pharmaceutical industry, as well the biotech industry.