PPharma Preclinical Lab for API Comparison, Pilot and Pharmacokinetic Studies
Preclinical Laboratory needed for comparison, pilot and pharmacokinetic studies on a single active pharmaceutical ingredient from different brands. A pilot study on different brands of a particular active
1.Quality control checks on the products: weight variation, friability, content uniformity, hardness, disintegration test, dissolution test, identification test, thickness &hardness, and Assay
2. Determination, isolation, characterization and quantitation of different impurities potentially present.
3. Possible Forced degradation studies to determine and changes in drug qualities with a repeat of the above tests. * Impact of temperature, light, oxygen, water etc
4. Pharmacokinetic studies in SIF and SGF of samples as well as forced degraded samples.
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