The 3rd Workshop on
Recent Issues in Regulated Bioanalysis
Highlights of 3rd Bioanalytical Workshop (April 2009)
In continuation of 2007 and 2008 Workshop, the 3rd edition in 2009 addressed both new issues and follow-ups on the progress of the resolutions agreed upon before.
Updates on ISR:
Dr. Brian Booth from FDA updated us on FDA's Experience after 1 year of ISR data, and current status of FDA guidance.
Peter van Amsterdam from Solvay Pharmaceuticals and European Bioanalysis Forum (EBF) Steering Committee covered EBF's ISR recommendations
Dr. Stephen Lowes from Advion explained how to perform a scientific Investigations in the event of ISR failure. What kind of action is required if ISR values do not agree with the original assay result?
We evaluated how the industry is dealing with the new FDA recommendations of using more than 20 samples for ISR.
We assessed the data and experience that the industry has acquired after one year of performing ISR data by considering regulatory requirement vs. good science.
New EMEA Guidance and Guidelines:
Louise Mawer from MHRA updated us on new EMEA Bioequivalence Guidance.
There was also updates on the 'Concept Paper/Recommendations on the Need for a (CHMP) Guideline on the Validation of Bioanalytical Methods' that the EMEA has recently published.
Challenges in Bioanalysis:
Dr. Patrick Vallano from Mylan talked about the assessment of processed sample stability.
Dr. Douglas M. Fast from Pfizer updated the latest news, perspectives and suggestions for performing a modernizations on USA GLP.
Dr. Mario Rocci from Prevalere presented the challenges with bioanalytical method development, qualification & transfer.
Dr. Rupinder Phull from Barr Laboratories explained the multiple difficulties and challenges involved in the bioanalysis of endogenous drugs.
Dr. Robert Masse from Anapharm-PharmaNet updated us about the most recent data on how unstable metabolites can impact bianalytical assay performance.
Dr. Xia Yin from Apotex lectured about the impact of concomitant medications on method specificity.
There were advices from opinion leaders on how to cope with Acetonitrile (ACN) Worldwide shortage.
Updates from Health Canada TPD (Canadian Authority):
Eric Ormsby from Health Canada TPD introduced the new Health Canada TPD Bioequivalene Guideline (2009) and how they affect CROs and Pharmas.
With a growing number of submissions from foreign companies to Canadian authority, Eric Ormsby also talked about the most common foreign study issues and Good Clinical Practice Guidelines.
Instruments/Techniques that Can Improve Quality in Regulated Bioanalysis:
When and How Much 'Anomalous Results' Need to be Investigated?
Authorities in the field shared opinions and experiences about acceptation vs. rejection of evaluations/batches that meet acceptance criteria but scientifically disputable.
How regulatory agencies 'feel' about the rejection of data that meet acceptance criteria borderline was also discussed.
New or Emerging Guidelines on Method Development and Validation:
- We discussed the most recent industry standards and regulatory agencies perspective on which extra tests performed during method development should be re-performed during the validation.
- Hemolysis testing
- Metabolite testing
- OTC metabolites
- Variable injection volumes
- Cross-validation between different anticoagulant salt forms
