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The reference material should be sufficiently uniform in the various parts of the material so that the value(s) refers to the properties of any other batch of reference material.
For all analysis, except the comparison of anticoagulants, the plasma derived from EDTA-stabilized blood samples was used and all samples measured were coming from the same batch of reference samples.
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The further tested buffered formulations included two reference batches from the BE studies (Lipitor and Sortis10), plus one other batch of the reference product, Sortis06.
For the prepared batch of materials, reference values 1.26 ± 0.91 (ng/fibre) for benzene and 11.3 ± 7.4 (ng/fibre) for toluene were determined.
Three goats vaccinated at CIRAD with a batch of the reference vaccine displayed rapid marked seroconversion, which was detectable after as little as one week.
Large batches of reproducible reference RNA solve these problems.
Bioavailability of the five generic batches was compared with three batches of the reference product (atorvastatin 80 mg manufactured by Pfizer, under the brand names Lipitor and Sortis, sold on different markets), in total of four consecutive PK studies.
In five of the batches processed at UC Davis one reference array was included, and the sixth batch is composed entirely of reference arrays.
The working group organized in the Generic Committee focusing on itraconazole found batch-to-batch variations in dissolution profiles of the originator capsule product, which suggested possible differences in the performance of reference batches for the development of generic products.
We batch imported our FASTA file of reference gene sequences into an R data frame and identified the tag positions by searching for "GATC" (Additional file 1).
The National Institutes for Food and Drug Control NIFDCC) has established the first batch of Vero cell DNA reference standards (Approval No: 2011-NRS0044).
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