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Licensing considerations

Each of these actions will require regulatory approval within each country. Specific structural integrity assessments will need to be performed to satisfy [Pg.152]

ASME (1999a), ASME Boiler and Pressure Vessel Code Case N-629, Use of fracture toughness test data to establish reference temperature for pressure retaining materials, Section XI, Division i, American Society of Mechanical Engineers, New York. [Pg.153]


The R D requirements for commercialization of the SCWR include addressing issues associated with SCWR materials and structures, safety and licensing considerations, and plant design issues. [Pg.307]

Questions that relate to specific considerations contained in company environmental guidelines apply to licensing and tolling of products (all or m part). They do not apply to suppliers of laboratory quantities of proprietary materials, raw material suppliers, or arrangements made with other companies to recover nonproprietary raw materials (for example, solvents and metal compounds). [Pg.165]

The licensing process consists of two steps construction and operating license that must be completed before fuel loading. Licensing covers radiological safety, environmental protection, and antitru,st considerations. Activities not defined as production or utilization of special nuclear material (SNM), use simple one-step. Materials Licenses, for the possession of radioactive materials. Examples are uranium mills, solution recovery plants, UO fabrication plants, interim spent fuel storage, and isotopic separation plants. [Pg.19]

Boiler operational management processes vary considerably in their degree of complexity. At larger facilities these processes are controlled by managers who are always qualified engineers (usually mechanical or electrical) and their operators are typically also appropriately qualified and licensed. [Pg.119]

Even on a relatively small subset of reused data, it is possible to license old medicines for new therapeutic applications and greatly reduce the costs of clinical development—many of these reused medicines have already passed muster for pharmacokinetic safety, so smaller-scale clinical trials are possible, saving considerable money (e.g., Arakis—soon to become Sosei). Even Sildenafil may have new indications [39]. There are huge potential reserves of information to mine in each and every large pharmaceutical company ... [Pg.180]

In the near future new drugs for the treatment of Alzheimer s disease are expected to be licensed, and it would be extremely valuable to be able to compare them in a clear and well-defined framework. In addition, if economic evaluation is to inform health and social care providers and policy-makers about the potential impact of new interventions in practice, estimation of the value for money of these new interventions requires consideration of (a) the perceived and objective risks and benefits of care (b) attitudes of people with... [Pg.85]

Any remedial scheme involves considerable expense to design, license, implement, operate, and monitor. As such, there is much emphasis currently on under-... [Pg.461]

This study concentrates only on patents directly issued to Eastman Kodak, CDT, UDC, Dow Chemical, Covion, IK, and DuPont without the consideration of patent reassignments. If licensed patents are taken into account, the patent landscape of these companies will change significantly. The patents listed for each company are only a part of the IP portfolio in the OLED arena. [Pg.653]

I do not take these considerations as a license not to compute the correct trajectory in an MD simulation. I do take them as showing that unless one really wants a complete dynamical description, one is over-computing. In other words, if all I want to know is whether a reaction did or did not take place, the precise knowledge of where all the atoms of the system are is not needed. [Pg.213]

The demonstration of genotoxic activity in a pharmaceutical molecule may not necessarily translate into discontinuation of development and ultimate licensing of the product to be marketed. A survey of the Physicians Desk Reference reveals many examples of pharmaceutical products that have been shown to elicit genotoxic activity in one or more gene-tox assays.41 This observation indicates that other factors (such as risk, benefit, seriousness of ailment, target patient population, dosage, and frequency of administration, among others) are taken into consideration. [Pg.309]

If the secret work of the CIA had been excluded from consideration, the researchers wouldn t have found much. Gottlieb had destroyed most of those records in 1973 as directed by CIA director Helms. It is no sunrise that the IG had difficulty investigating them. As the report writers explain in their prologue Where neither documentary or testimonial evidence was available, then license was taken by drawing logical conclusions or assumptions based on evidence available, past performance, or other indicators. (Unfortunately, the need for such assumptions would tend to weaken the reliability of their conclusions.)... [Pg.245]

While large-scale commercialization of the 3D chip has taken considerably more hme than expected, several companies now offer such surfaces. Motorola Life Sciences abandoned the Mirzabekov gel (Chapter 3) in favor of SurModic s PhofoLink surface chemistry (www.surmodics.com), chemistry which it then brought to market as the CodeLink . Amersham Biosciences acquired CodeLink from Motorola in 2002 and obtained a license to the Southern patents in 2003 to expand the product into the clinical diagnoshc arena. [Pg.45]


See other pages where Licensing considerations is mentioned: [Pg.19]    [Pg.151]    [Pg.152]    [Pg.152]    [Pg.249]    [Pg.19]    [Pg.151]    [Pg.152]    [Pg.152]    [Pg.249]    [Pg.107]    [Pg.108]    [Pg.40]    [Pg.466]    [Pg.282]    [Pg.88]    [Pg.241]    [Pg.269]    [Pg.603]    [Pg.169]    [Pg.241]    [Pg.70]    [Pg.74]    [Pg.198]    [Pg.176]    [Pg.162]    [Pg.1317]    [Pg.48]    [Pg.132]    [Pg.12]    [Pg.115]    [Pg.330]    [Pg.254]    [Pg.223]    [Pg.233]   


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