Conference Report: The 3rd EBF Focus Meeting: ‘Hatching’ – emerging technologies approaching the regulated bioanalysis laboratory-Reference-Cited by-同舟云学术

Conference Report: The 3rd EBF Focus Meeting: ‘Hatching’ – emerging technologies approaching the regulated bioanalysis laboratory

Published:2012-12 Issue:23 Volume:4 Page:2769-2774
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Dijksman Jessica¹,Henderson Neil²,Ingelse Benno³,Mulder Hans⁴,Smeraglia John⁵,Timmerman Philip⁶,Brudny-Kloeppel Margarete⁷,Companjen Arjen⁸,van Amsterdam Peter⁹

Affiliation:

1. Solusacta, The Netherlands

2. AstraZeneca, Sweden

3. MesoScale Discovery, The Netherlands

4. Astellas, The Netherlands

5. Huntingdon Life Sciences, UK

6. Janssen Bioanalysis Department, a division of Janssen Pharmaceutica NV, Turnhoutseweg 30, Beerse, Belgium.

7. Bayer Healthcare, Germany

8. Crucell, The Netherlands

9. Abbott Healthcare Products, The Netherlands

Abstract

One hundred and eighty scientists from industry and academia discussed the progress in emerging technologies approaching regulated bioanalysis, with a focus on what potential hurdles prevent them becoming broadly accepted by industry and regulators. The conference delegates agreed that moving innovative technologies forward can only be achieved by providing solid data to support the application. In addition, also establishing an open dialogue with health authorities is key for success. By successfully integrating new technologies in the bioanalytical laboratory we contribute to bringing more safe and efficacious therapies faster to patients.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Link

http://www.future-science.com/doi/pdf/10.4155/bio.12.273

Reference6 articles.

1. European Medicines Agency.Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. European Medicines Agency, London, UK (2009).

2. Committee for Medicinal Products for Human Use.Guideline on bioanalytical method validation. European Medicines Agency, London, UK (2011).

3. Perspectives on microsampling: DBS

4. European Bioanalysis Forum.www.europeanbioanalysisforum.eu

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