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Stage 2 Investigation

For a subject to be harmonized retrospectively, the coordinating pharmacopeia collects the information on the existing specifications in the three pharmacopeias, on the grades of products marketed, and on the potential analytical procedures. [Pg.85]

The coordinating pharmacopeia prepares a draft monograph or chapter, accompanied by a report giving the rationale for the proposal with validation data. [Pg.85]

Stage 2 ends with the proposal draft, which is mentioned in this procedure as a Stage 3 draft. The Stage 3 draft, accompanied by supporting comments or data that explain the reasons for each test procedure or limit proposed, is sent by the coordinating pharmacopeia to the secretariats of the other two PDG pharmacopeias. [Pg.88]


Stage 2 Investigation on fhe existing specifications, on the grade of products marketed and on the potential analytical methods Preparation of a first draft text ( Stage 3 draft )... [Pg.560]

A slurry bed reactor is in a pilot stage investigation. This type is characterized by having the catalyst in the form of a slurry. The feed gas mixture is bubbled through the catalyst suspension. Temperature control is easier than the other two reactor types. An added advantage to slurry-bed reactor is that it can accept a synthesis gas with a lower H2/CO ratio than either the fixed-bed or the fluid-bed reactors. [Pg.126]

Gaboxadol (9) is a selective extrasynaptic GABA receptor agonist in late-stage investigation for the treatment of insomnia. The action of this compound was extensively reviewed in Chebib et al. [13] and updated in Wafford et al. [23]. Nevertheless, the sponsor companies Merck Co., Inc., and H. Lundbeck A/S announced in March 2007 that the results from recently completed clinical studies do not support further development and announced the discontinuation of their joint development program for gaboxadol. [Pg.67]

The CP experiment can be extended to double CP e.g. H—>X->Y. The initial CP is used to enhance the sensitivity of the experiment and the second stage investigates the connectivity of the X and Y nuclei. This approach has become particularly well developed for C and N to probe the connectivity of biomolecular solids (Schaefer et al. 1984). [Pg.177]

Compatibility requirements—with product, involving testing stages, i.e. feasibility stages (investigational) and formal stability stages. [Pg.229]

Radiographic contrast media contain iodine and need to be avoided prior to radioiodine scans or treatment. Due to the difficulty in achieving an iodine deficiency state following the use of contrast media, the inadvertent use of such media can delay radioiodine administration for 6 months. This restriction is of particular relevance in CT scans used as a staging investigation for thyroid cancer, for which contrast must be avoided. [Pg.963]

A two-stage test plan for the flex abrasion experiments of the organic fibres was developed. The first stage investigates the influence of mechanical parameters and heterogeneity of organic fibres. Second stage deals with thermal and chemical treatment, which is not part of the current case study, and is planned to be examined in the further research work. [Pg.1852]

The initial exploration stage investigates a product or process concept to assess its commercial potential. The areas considered include the following. [Pg.220]

Imagine for a moment that the exploration activities carried out in the previous section have resulted in a successful discovery well. Some time will have passed before the results of the exploration campaign have been evaluated and documented. The next step will be the appraisal of the accumulation, and therefore at some stage a number of additional appraisal wells will be required. The following section will focus on these drilling activities, and will also investigate the interactions between the drilling team and the other E P functions. [Pg.29]

The amount of detail input, and the type of simulation model depend upon the issues to be investigated, and the amount of data available. At the exploration and appraisal stage it would be unusual to create a simulation model, since the lack of data make simpler methods cheaper and as reliable. Simulation models are typically constructed at the field development planning stage of a field life, and are continually updated and increased in detail as more information becomes available. [Pg.206]

McFeely F R, Morar J F, Shinn N D, Landgren G and Himpsel F J 1984 Synchrotron photoemission investigation of the initial stages of fluorine attack on Si surfaces relative abundance of fluorosilyl species Phys. Rev. B 30 764-70... [Pg.2941]

There is no satisfactory chemical way of distinguishing betn een ethane and methane, both of which burn with an almost non-luminous flame this fact however is quite unimportant at this stage of the investigation. Hydrogen also burns with a non-luminous flame and w hen the open end of a test-tube full of the gas is placed in a Bunsen flame, a mild explosion with a very characteristic report takes place. [Pg.329]

Other Uses. Other uses of hGH, eg, for bums, wound healing, cachexia, osteoporosis, aging, malnutrition, and obesity, are being investigated. These uses are ia various stages of development and trials are being carried out by several different pharmaceutical companies. [Pg.197]


See other pages where Stage 2 Investigation is mentioned: [Pg.88]    [Pg.85]    [Pg.1963]    [Pg.85]    [Pg.450]    [Pg.92]    [Pg.206]    [Pg.266]    [Pg.129]    [Pg.121]    [Pg.176]    [Pg.66]    [Pg.152]    [Pg.42]    [Pg.407]    [Pg.175]    [Pg.67]    [Pg.89]    [Pg.130]    [Pg.88]    [Pg.52]    [Pg.997]    [Pg.998]    [Pg.1656]    [Pg.1687]    [Pg.130]    [Pg.396]    [Pg.657]    [Pg.74]    [Pg.326]    [Pg.365]    [Pg.44]    [Pg.265]    [Pg.294]    [Pg.406]    [Pg.530]    [Pg.41]    [Pg.252]    [Pg.326]    [Pg.52]    [Pg.393]    [Pg.275]    [Pg.30]   


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The Investigation of Multi-Stage Processes

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