Voorbeelden van het gebruik van Fpps in het Engels en hun vertalingen in het Nederlands
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Programming
Data package required for the prequalification of APIs and FPPs.
FPPs intended for storage below -20 °C should be treated on a case-by-case basis.
ICH Q6A should be consulted for the development of specifications for FPPs.
The manufacture of sterile FPPs needs to take place in a well-controlled manufacturing area nt.
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For extended release FPPs, the time-points should be set to cover the entire duration of expected release.
specific tests and criteria for FPPs.
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corresponding multisource products should not be inferior to new APIs and innovator(comparator) FPPs.
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Modified-release FPPs should have a meaningful in vitro release rate(dissolution) test that is used for routine quality control.
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For blend uniformity testing of low-dose FPPs, blend drawn using a sampling thief from x positions in the blender.
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For extended-release FPPs, the testing conditions should be set to cover the entire time period of expected release nt.
in formulating FPPs and in the testing for release and stability purposes.
remove microorganisms is probably the single most important process in the manufacture of parenteral FPPs.
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the officially recognized pharmacopoeias should be consulted for recommendations on the packaging information for FPPs.
Immediate-release solid FPPs(with noted exceptions)
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finished pharmaceutical products should be consulted for recommendations on the core stability data package required for the prequalification of APIs and FPPs.
Other storage conditions are outlined in the WHO stability guidelines for FPPs packaged in impermeable
after first opening of FPPs packed in bulk multidose containers nt.
or liquid FPPs containing undissolved API,
finished pharmaceutical products FPPs.