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Smitha ☆ India, 2015-07-09 09:48 (3207 d 08:17 ago) Posting: # 15057 Views: 4,201 |
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Dear all, We are planning to conduct a FDA submission study in 3 groups (due to logistic limitations). My query was on the analysis of the subjects in the Bioanalytical Lab. Is it acceptable that the bioanalysis of Group 1 subjects (Periods 1 and 2) be initiated before the dosing of Group 2 and Group 3 subjects? The randomization schedule is tightly controlled with no access to the Analysts and the subject concentrations will not be shared with the Clinical unit. Would appreciate the opinion of the forum members on the acceptability of this plan and any thoughts to the contrary. Regards, Smitha |
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Smitha ☆ India, 2015-07-13 08:52 (3203 d 09:13 ago) @ Smitha Posting: # 15072 Views: 3,345 |
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Dear all, Would appreciate it if any of the forum members would respond  Regards, Smitha Edit: Four day ≠ two weeks. See the Forum’s Policy. We are posting in our spare time. If you want a quick answer, higher a consultant. [Helmut] |
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jag009 ★★★ NJ, 2015-07-22 18:23 (3193 d 23:42 ago) @ Smitha Posting: # 15127 Views: 3,183 |
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Hi, ❝ We are planning to conduct a FDA submission study in 3 groups (due to logistic limitations). Is this a parallel study or a crossover study with groups? You have a timeline issue? If not, I would prefer to finish all dosing and PK samplings before starting bioanalytical. John |
Ing. Helmut Schütz