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Toxicity studies should be designed not only to identify a safe dose, but also a toxic dose(s) to anticipate the product s safety and to better define the therapeutic index in humans. Specific product considerations that may complicate the process of defining a toxic dose may include limits based on formulation, lack of significant systemic absorption, or the amount of the product available. The lack of significant toxicity in animals does not necessarily mean that the product is safe. The margin of safety for the initial starting dose, however, will likely be adequate. [Pg.413]

AC waxes are a range of low-molecular-weight polyethylene performance products available from Honeywell (formerly from Allied Chemicals). Further details are available on the web site [http //www.acperformanceproducts.com/index.html]. [Pg.530]

WDI, the Derwent World Drug Index, is available from Derwent Publications Ltd., http //thomsonderwent.com/products/ Ir/wdi/ and from Daylight Chemical Information Systems, http //www.daylight.com/ products/databases /W DI. html. [Pg.237]

If You Want to Contact the Manufacturer for More Information about the Drug. Look in the Manufacturers Index located in the WHITE pages at the very beginning of the PDR. Manufacturers who have contributed to the PDR are listed alphabetically, with an address and phone number that serve as a source for inquiries. In addition, a partial listing of the products available from each manufacturer is included following the manufacturer s name and address. [Pg.622]

ICH Q5D Q5D. Quality of Biotechnological/Biological Products Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/ Biological Products Availability, 1998. http //www.fda.gov/cder/guidance/ index.htm... [Pg.472]

CDs are capable of carrying prodigious amounts of information, over 600 megabytes on a single disk, hi addition to the music and film formats, CD-ROMs bring extensive databases to the desktop computer, and the average user s fingertips. World atlases, encyclopedias, and comprehensive periodical indexes are just a few of the CD-ROM products available. [Pg.659]

One possible compromise here would be to develop an index based on the performance of a neutral agent that only mechanically removes viruses from hands. In the past, nonmedicated soaps have often been used for this purpose. However, soaps on the market differ widely, especially in properties such as pH and detergent action. Tap water also differs at different geographical locations. Therefore, a simple, safe, and readily available solution such as standard hard water (e.g., with 200 ppm hardness) could be used to establish the reference point for this index. Product efficacy claims could then be allowed at a certain differential above the mechanical virus removal with hard water. Manufacturers could publish the performance index of their formulation on the label to aid in product selection. To prevent minor differences in indices being used as a sales feature, a simple product classitication scheme could be developed. [Pg.420]

Nonmetallic Mineral Products Industry Indexes http //minerals.usgs.gov/minerals/pubs/ imii/ (accessed July 11, 2010). The USGS has prepared leading and coincident indexes for the Nonmetallic Mineral Products Industry (NAICS 327). The former name for this industry was the Stone, Clay, Glass, and Concrete Products Industry (SIC 32) under the Standard Industrial Classification (SIC) system. The SIC has been replaced by the North American Industry Classification System (NAICS). These indexes are similar to the ones in Metal Industry Indicators. The latest report for these indexes, November 2004, is available in PDF format. Historical data for these new indexes are available back to 1948. See also the section on Statistics for a discussion on the Statistical Compendium (U.S. Bureau of Mines) and the USGS Commodity Statistics and Information. [Pg.443]

A detailed record of products available on the market is presented under each color index reference. Each product name is listed the manufacturer, physical form, principal usages and comments supplied by the manufacturer to guide prospective customers. [Pg.41]

UNIfHY, June 2015. Unique Gasifier for Hydrogen Production. Available from http //www. unifhy.eu/index.asp. [Pg.493]

The basic condition of the Standard application - the availability of stable coupled probabilistic or the multiple probabilistic relations between then controlled quality indexes and magnetic characteristics of steel. All the probabilistic estimates, used in the Standard, are applied at confidence level not less than 0,95. General requirements to the means of control and procedure of its performance are also stipulated. Engineers of standard development endeavoured take into consideration the existed practice of technical control performance and test at the enterprises that is why the preparation of object control for the performance of nondestructive test can be done during the process of ordinary acceptance test. It is suggested that every enterprise is operated in correspondence with direct and non-destructive tests, obtained exactly at it, for detailed process chart and definite product type, however the tests have long since been performed after development of the Standard displayed that process gives way to unification. [Pg.25]

Four column systems are available from Amersham Pharmacia Biotech that can be used to pack SEC media for various applications at the laboratory scale. These include C, XK, SR, and HR column systems. All of the laboratory-scale columns are constructed with borosilicate glass tubes. Columns for larger scale process applications include INdEX, BPG, EineLINE, BPSS, and Stack columns. The larger scale columns are constructed to meet stringent validation requirements for the production of biopharmaceuticals. Each of the column types are described. [Pg.54]

In the case of European legislation there is a published information source that contains many of the relevant documents. This is the hard copy or electronic version of the multiple volumes of The Rules Governing Medicinal Products in the European Union. The most convenient way to obtain these documents—which will eventually consist of nine volumes, some of which will have several parts—is via the internet. The available volumes can be found by way of the following web address http //dg3.eudra.org/eudralex/index.htm. The volumes relevant for human medicinal products are ... [Pg.645]


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See also in sourсe #XX -- [ Pg.1496 , Pg.1497 ]




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