Bioanalytical Aspects in Biological Therapeutics
- Indbinding:
- Hardback
- Sideantal:
- 400
- Udgivet:
- 25. oktober 2022
- Størrelse:
- 236x159x30 mm.
- Vægt:
- 722 g.
- Ukendt - mangler pt..
Normalpris
Abonnementspris
- Rabat på køb af fysiske bøger
- 1 valgfrit digitalt ugeblad
- 20 timers lytning og læsning
- Adgang til 70.000+ titler
- Ingen binding
Abonnementet koster 75 kr./md.
Ingen binding og kan opsiges når som helst.
- 1 valgfrit digitalt ugeblad
- 20 timers lytning og læsning
- Adgang til 70.000+ titler
- Ingen binding
Abonnementet koster 75 kr./md.
Ingen binding og kan opsiges når som helst.
Beskrivelse af Bioanalytical Aspects in Biological Therapeutics
Bioanalytical Aspects in Biological Therapeutics
Deepen your understanding of how critical data are generated from bioanalysis
In Bioanalytical Aspects in Biological Therapeutics, a team of renowned chemists, immunologists, and biologists delivers a timely and practical exploration of the diverse scientific and technical literature on the bioanalytical investigation of current biotherapeutics under development. The book discusses the challenges and considerations for bioanalytical support, covering a wide range of central topics in the field, including overview and basic immunology for testing of biological therapeutics, pharmacokinetic aspects, clinical immunogenicity prediction and testing, biomarker testing, biotransformation assessment for biologics, statistical aspects of bioanalytical testing, regulatory expectations, and more.
Drug development and analysis professionals will learn how critical data are generated from bioanalysis and how proven tools and methods are applied to the development of biologics. Alongside coverage of topics like PK, immunogenicity, neutralizing antibody assays, and the importance of quality control for reagents, readers will benefit from:
* A thorough overview of the development of biotherapeutics and the role played by bioanalytical tests, as well as basic immunology for bioanalytical testing of biological therapeutics
* Comprehensive explorations of platform and instrument considerations in bioanalytical testing, pharmacokinetics assays, and biomarker analysis using LC-MS, LBA, and other technologies
* Practical discussions of immunogenicity prediction, preclinical and clinical anti-drug antibody assays, and bioanalytical schemes for anti-drug neutralizing antibody assays
* In-depth examinations of critical reagents in bioanalysis
* Regulatory expectations for bioanalytical method development, validation, and sample testing
Perfect for pharmaceutical scientists in industry, Bioanalytical Aspects in Biological Therapeutics will also earn a place in the libraries of pharmaceutical regulators and other professionals working in pharmaceutical companies, as well as graduate students studying bioanalytical assays for biological therapeutics.
Deepen your understanding of how critical data are generated from bioanalysis
In Bioanalytical Aspects in Biological Therapeutics, a team of renowned chemists, immunologists, and biologists delivers a timely and practical exploration of the diverse scientific and technical literature on the bioanalytical investigation of current biotherapeutics under development. The book discusses the challenges and considerations for bioanalytical support, covering a wide range of central topics in the field, including overview and basic immunology for testing of biological therapeutics, pharmacokinetic aspects, clinical immunogenicity prediction and testing, biomarker testing, biotransformation assessment for biologics, statistical aspects of bioanalytical testing, regulatory expectations, and more.
Drug development and analysis professionals will learn how critical data are generated from bioanalysis and how proven tools and methods are applied to the development of biologics. Alongside coverage of topics like PK, immunogenicity, neutralizing antibody assays, and the importance of quality control for reagents, readers will benefit from:
* A thorough overview of the development of biotherapeutics and the role played by bioanalytical tests, as well as basic immunology for bioanalytical testing of biological therapeutics
* Comprehensive explorations of platform and instrument considerations in bioanalytical testing, pharmacokinetics assays, and biomarker analysis using LC-MS, LBA, and other technologies
* Practical discussions of immunogenicity prediction, preclinical and clinical anti-drug antibody assays, and bioanalytical schemes for anti-drug neutralizing antibody assays
* In-depth examinations of critical reagents in bioanalysis
* Regulatory expectations for bioanalytical method development, validation, and sample testing
Perfect for pharmaceutical scientists in industry, Bioanalytical Aspects in Biological Therapeutics will also earn a place in the libraries of pharmaceutical regulators and other professionals working in pharmaceutical companies, as well as graduate students studying bioanalytical assays for biological therapeutics.
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