Equipment
selection in formulation plants
Any mismatch or mistake in equipment
selection can play havoc on all parameters of manufacturing
activity, says G B Sastry in first part of the article
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‘Hypertensive
patients should be excluded from long term trials’
This is regarding phase III
clinical trial for an anti-hypertensive drug. As per
ICH-GCP- E12 A, page 4, for the short term studies,
a three arm design (test drug, active control drug,
and placebo) may be particularly helpful as a study
that not only supports efficacy but also makes a comparison
with standard therapy.
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