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Exact(27)
32 Reconstitution of the lyophilized degarelix powder involves addition of sterile water to the product vial followed by swirling to minimize production of foam.
The connection between the cassette and the final product vial is upstream of the sterilizing filter.
The final product was passed through 0.22 μm sterile filter to sterile product vial.
The final product, [18F]F-Gln, was eluted with saline into the final product vial.
Liquid receiver with the product vial was then connected to the bottom of the reactor.
The final formulation was prepared by adding 15 mL saline into the final product vial.
Similar(33)
The HD study was designed to examine the mass dose effect on pharmacokinetics and to demonstrate the practicability of delivery of F-florbetaben from a production site to distant PET imaging sites, for which product vials containing higher radioactivity are produced to compensate for the radioactive decay during the transportation.
In addition, when possible, used product vials from the PDSS events were collected for analysis.
Most participants reported using FVIII product vials before vial expiration; however, eight survey respondents (7.9% of overall sample) indicated that they had FVIII product vials that expired and could not be used.
Overall, caregivers and patients responded similarly to questions about product usage, with the exception of the number of FVIII product vials typically infused at one time.
The drug product samples were prepared by reconstituting ten drug product vials with normal saline to obtain a final concentration of 1 mg/mL based on label claim.
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