Expedited procedures

Expedited reviews The new Regulation foresees the possibility of an expedited procedure of only 150 days duration, for products of major interest for public health, which are addressing an unmet medical need. Also, a conditional approval may be granted, which would be reviewed yearly. 

It is recommended that one check the exponential matrix obtained using this expedited procedure with the exponential matrix obtained using Maple s exponential matrix command for at least two values of interior node points (for e.g., N = 2, 4 etc). Once it is verified that the above procedure works for a particular problem, one can use the procedure for obtaining the exponential matrix efficiently for high values of N. 

Expedited reviews are used by IRBs to review and approve minor changes in previously approved research, either because the change is administrative in nature or because the research (or change in the research) involves no more than minimal risk to the subject. This procedure requires only the IRB chairperson s review or review by one or more reviewers designated by the chairperson who are voting members of the IRB. In addition, when and if the expedited procedure is invoked, every member must be advised of all approvals made via this procedure. It is important to note that expedited review procedures are used only under the limited circumstances addressed above and do not replace a full IRB review of research proposals. 

Expedited procedures for conceptual profiling of brands, products and packaging... 

The expedited procedures described herein provide a practical and cost effective means of conceptual profiling and consequently for obtaining a derived index of fit-to-brand, within the context of routine new product development. 

Wu and Lindell (2004) provide an insight into some of the actions that were taken to increase the speed of housing reconstruction in Los Angeles after the earthquake showing that it is possible to expedite procedural requirements by establishing fast-tracked processes that would operate after a disaster would benefit recovery. 

The other cause of constmction problems is the introduction of badly chosen, or even unauthorized, changes during constmction in order to expedite the work. Any changes in details, material specifications, or erection procedure must be given careful consideration by both the builder and silo designer. 

Use of topical retinoids (tretinoin, tazaro-tene, retinol formulations) for 2 to 6 weeks prior to peeling thins the stratum cornemn, reduces the content of epidermal melanin, and expedites epidermal healing. Retinoids also enhance the penetration of the peeling agent. They should be discontinued several days prior to the peeling procedure. Retinoids can be resumed post-operatively after all evidence of... 

Review of postcontrast CTA source images might provide a good estimate of whole-brain perfusion." If time allows, MR or CT perfusion maps are obtained to characterize more accurately the ischemic penumbra." Careful but expedited preprocedural analysis of the CTA, done in parallel with transport of the patient to the treatment area, may be extremely helpful in establishing the presence of anatomic variants (e.g., bovine aortic arch) or pathological states (e.g., vessel origin or carotid bifurcation disease) prior to the catheterization procedure. 

A facile method for the oxidation of alcohols to carbonyl compounds has been reported by Varma et al. using montmorillonite K 10 clay-supported iron(III) nitrate (clayfen) under solvent-free conditions [100], This MW-expedited reaction presumably proceeds via the intermediacy of nitrosonium ions. Interestingly, no carboxylic acids are formed in the oxidation of primary alcohols. The simple solvent-free experimental procedure involves mixing of neat substrates with clayfen and a brief exposure of the reaction mixture to irradiation in a MW oven for 15-60 s. This rapid, ma-nipulatively simple, inexpensive and selective procedure avoids the use of excess solvents and toxic oxidants (Scheme 6.30) [100]. Solid state use of clayfen has afforded higher yields and the amounts used are half of that used by Laszlo et al. [17,19]. 

FDA, Protection of Human Research Subjects Clinical Investigations Which May Be Reviewed Through Expedited Review Procedure Set forth in FDA Regulations, Federal Register 46(8980), January 27,1981. 

In summary, this chapter reviews how to develop expedited calibration procedures and acceptance criteria for all the common modules in an HPLC system. 

Bisulfite treatment kits have been developed and are commercially available (e.g., Qiagen bisulfite treatment kit). Kits work with the same efficacy and have helped streamline the procedure, which will help expedite the process because of the elimination of setup time. Beginners are encouraged to use a kit, especially when there is not enough DNA to calibrate the conditions for bisulfite treatment. 

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