Bioequivalence and Bioavailability Forum • Add'l requirements

Add'l requirements [Bioanalytics]

posted by ElMaestro – Denmark, 2012-12-23 06:10 (4540 d 03:03 ago) – Posting: # 9749
Views: 8,010

Dear all,

further: With immediate effect EMA adds a few new requirements for PK studies:

All CRO technicians must have at least a doctorate and 10 years documented work experience. Which educations correspond to acceptable functions will be assessed on a case-by-case basis but also note pt. 5.
The educating institutions for lab techs will be inspected at 20% coverage by regulators.
CRO technicians who work on the liquids must each morning prior to commencing work be dosed beta blockers or other appropriate anti-tremor medication.
Pipettes must be calibrated daily by a certified institution.
Computer systems used to calculate the 90% CI may only be used once due to the risk of RAM burning or harddisk failure which may or may not affect the system's ability to calculate. Validate before use.
The GLP study director must be an MD because they tend to know a lot about analytical chemistry.
Ramipril and Clopidogrel are specifically discouraged.
The CRO must, as part of the validation, prove 8 years stability of stock solutions. This needs to be done at low, middle and high barometric conditions.
Requirements 1-8 do not apply to originator developments, because phase 3 safety studies usually imply so many blood samples anyway.

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Pass or fail!
ElMaestro