Previous human experience reports

Previous human experience with the investigational drug Summary report of any U.S. or non-U.S. human experience with the drug... 

Protocols [ 312.23(a)(6)], protocol amendments [ 312.30], previous human experience [ 312.23(a)(9)], safety reports [ 312.32] and informational amendments related specifically to clinical [ 312.31] including adverse reactions, consent forms, investigator information, general investigational plan, Investigator s Brochures, IRB approval, new protocols, revised protocols, site information, investigator data, CVs, and 1572s... 

Previous Human Experience You should provide previous human experience in a separate PDF file that is reserved for summary information. You should include a TOC in the previous human experience file. You should name the file XXXX prevhumexptoc.pdf You should bookmark and hypertext link the TOC for this file. If you are providing study reports, you should provide them as described in the appropriate marketing guidance document. 

Ad H Previous Human Experience with the Investigational Drug may be presented in an integrated summary report. The absence of previous human experience should be stated. 

Interfacing the TEA to both a gas and a HPLC has been shown to be selective to nitro-based explosives (NG, PETN, EGDN, 2,4-DNT, TNT, RDX and HMX) determined in real world samples, such as pieces of explosives, post-blast debris, post-blast air samples, hand swabs and human blood, at picogram level sensitivity [14], The minimum detectable amount for most explosives reported was 4-5 pg injected into column. A pyrolyser temperature of 550°C for HPLC-TEA and 900°C for GC/TEA was selected. As the authors pointed out, GC uses differences in vapour pressure and solubility in the liquid phase of the column to separate compounds, whereas in HPLC polarity, physical size and shape characteristics determine the chromatographic selectivity. So, the authors reported that the use of parallel HPLC-TEA and GC-TEA techniques provides a novel self-confirmatory capability, and because of the selectivity of the technique, there was no need for sample clean-up before analysis. The detector proved to be linear over six orders of magnitude. In the determination of explosives dissolved in acetone and diluted in methanol to obtain a 10-ppm (weight/volume) solution, the authors reported that no extraneous peaks were observed even when the samples were not previously cleaned up. Neither were they observed in the analysis of post-blast debris. Controlled experiments with handswabs spiked with known amounts of explosives indicated a lower detection limit of about 10 pg injected into column. 

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