Anapharm Bioanalytics has participated in the III Workshop on Phase I Clinical Trials

Bioanalytical Method Validation: Progress and New Challenges
By Araceli Castillo, Anapharm Bioanalytics

On May 21st, 2018, the US FDA published the definitive guidance for the validation of bioanalytical methods. The document includes the comments made on the 2013 draft and reflects the progress in science and technology for the past five years.
As compared to the previous draft guidance, the structure of this new document has been improved and summary tables have been added to point out the requirements and acceptance criteria for carrying out each one of the assays. Moreover, recommendations on the documentation to be reported were also included.
As main changes, we can emphasize that the development of the methods has gained importance. Also, the sections of chromatographic techniques and LBA have been unified. These two points make this guidance different from previous bioanalysis guidelines published to date.
On the other hand, within the current regulatory framework, bioanalytical laboratories must meet the requirements of different countries in order to offer a global service and facilitate the development of a drug at international level. However, the guidelines for the validation of bioanalytical methods published in the different regions show discrepancies, not only in the parameters required, but also in the procedures for their evaluation.
In 2016, ICH took the initiative to prepare a multidisciplinary guideline for the validation of bioanalytical methods, M10, to harmonize different requirements among countries. The draft guide is expected to be available for public consultation at the beginning of 2019.
The publication of the US FDA guidance in the midst of the ICH harmonization process changes the current scenario. How this will affect the ICH draft guideline currently being discussed is yet to be seen.


30/10/2020 12:49

Successful WHO Inspection

Anapharm Bioanalytics is proud to announce that it has successfully undergone World Health Organization GCP/GLP compliance inspection at its Barcelona based bioanalytical lab

08/05/2020 14:29

Cell Lab | Anapharm Bioanalytics expands its laboratory capabilities

We are glad to inform you that a cell lab has recently been built at our facilities in Barcelona. Our brand new cell lab capabilities will enable the development and validation of a variety of assays such as Cell Proliferation, Ligand Stimulated Cell Signalling, Protein Secretion, Reporter Gene, NAbs, etc.

31/03/2020 10:03

Anapharm Bioanalytics Brazilian ANVISA Certificate Renewal

Anapharm Bioanalytics is proud to announce that it has recently (February 20th, 2020) renewed its ANVISA (Brazil) certificate. The renewed certification is valid until February 20th, 2022.