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While most of the generic drug products after 1980 were developed with human BE studies, the absence of dissolution specification in both the originator and corresponding generic products prior to 1995, suggested a lack of performance control.
The most utilised PPI was rabeprazole (DDDs basis), which had the highest expenditure/DDD for both the originator (when procured) and the generic versus the other oral PPIs (Table 2).
WHO/HAI methodology suggests that data for each medicine should be collected for both the originator brand, defined as the product that was first authorised for worldwide marketing, and for the lowest-priced generic equivalent found at each facility.
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For her part, Allon says that she reports to (and gets paid by) both the originators and the investors, thus helping ensure the integrity of the analysis.
After reading "Secrets from an Inventor's Notebook" in college, he talked his way into an apprenticeship with its author, Maurice Kanbar, the originator of both Skyy vodka and a type of lint remover, calling on Mr. Kanbar's office at least once a month for two years before landing a meeting.
The manuscript of Mulkidjanian et al presents a thoroughly documented and compelling argument for the primacy of an Na+ dependent ATPase as the originator of both V-type and F-type ATPase.
I could now speak to one of the last personal links with the originator and instrument of both the second world war, and of genocide and mass murder.
In the cases of Inflectra and Remsima, the phase I and III clinical trials showed that they had a highly similar profile to the originator product Remicade® in terms of both safety and efficacy.
For these countries, the retail channel (IMS) has more molecules with both an originator and at least one generic available than the procurement channel (GPRM).
In this case, own up to the originator of the information quickly, so that both of you can go into damage control as a team, rather than alienating each other.
The Food and Drug Administration FDAA) requires that the 90% confidence interval (CI) of the ratio of the geometric means for the generic compared with the originator falls between 80% and 125% for both AUC and Cmax (11).
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com