Translation of "New chemical entity" in German

Fexinidazole is the first new chemical entity to be successfully developed by DNDi .

Thus, the present application for Oracea (doxycycline 40 mg tablets) is not for a New Chemical Entity but aims to develop a formulation designed for once a day oral administration that could provide steady state doxycycline plasma concentrations at the anti-inflammatory level but not at the antimicrobial level.

Companies seeking to place a product containing a new chemical entity (“NCE”) on the market will be required to use the centralised authorisation procedure.

Companies seeking to place a product containing a new chemical entity (NCE) on the market will be required to use the centralised authorisation procedure.

An additional indicator of research performance for the pharmaceutical industry is the New Chemical Entity (NCE) introductions over time.

After initial pre-clinical research activities, a new chemical entity is evaluated in a dedicated First in Human (FIH) trial to obtain the initial information on the pharmacokinetics, pharmacodynamics, safety and tolerability of the new compound in healthy subjects after administration in escalating doses.

We offer a mechanical dose-counting system – a licensed design from 3M – suitable for any generic or new chemical entity development and compatible with all marketed pressurised MDI valves.

XADAGO, a once-daily tablet, is the first New Chemical Entity approved in the U.S. for PD-related motor fluctuations in more than a decade for the estimated 1 million patients currently affected by PD.

Based on its experience, DNDi concludes that its cost of development ranges from EUR 6-20 million for an improved treatment, and EUR 30-40 million for a new chemical entity.

XADAGO is the first New Chemical Entity (NCE) approved in the U.S. for motor fluctuations in Parkinson's disease in more than a decade.

Stefan Weber, CEO of Newron Pharmaceuticals said: "We are proud to see XADAGO become the first FDA approved new chemical entity for Parkinson's disease in more than 10 years.

XADAGO is the first New Chemical Entity approved for the treatment of PD-related motor fluctuations in the U.S. in over a decade.

In the US market, tolperisone is classified as a new chemical entity (NCE) and therefore must meet the regulatory requirements for clinical development and marketing imposed by the FDA.

Safinamide is a new chemical entity with a unique mode of action including selective and reversible MAO-B-inhibition and blocking of voltage dependent sodium channels which leads to modulation of abnormal glutamate release.

It shows that it is possible to bring a new chemical entity through the pipeline to offer an entirely new perspective on tackling a disease like sleeping sickness ', comments Dr Bernard Pécoul, DNDi's Executive Director.

It is the first new chemical entity to be developed by DNDi," said Dr Bernard Pécoul, DNDi Executive Director.

The term is five years for a new chemical entity and three years for a second indication.

Now the US has overtaken Europe in the discovery of new chemical or biological entities.

The Agency also contributed to the availability of a number of new medicines on the market, including new chemical entities and similar biological and generic medicines.

And whilst the US has since caught and overtaken Europe, the continent remains a solid medicines powerhouse, accounting for almost 40% of all new chemical entities and 30% of all patents filed.

In previous sections, the worldwide lead of Japan in producing New Chemical Entities (NCEs) in the last decade was firmly established.

This attitude has forced Japanese companies to adapt themselves to an ever changing environment, and the net result is their emergence, over the past five years, as the most innovative producers worldwide, in terms of New Chemical Entities.

Medicinal chemistry involves the identification, synthesis and development of new chemical entities suitable for therapeutic use.

The company also partners with large pharmaceutical and biotechnology companies to apply its proprietary technologies to new chemical entities or improve existing products.

In order to bring these "new chemical entities" (NCEs) to market as quickly as possible, the 2,700 m2 technology centre houses a number of synthesis laboratories, in which the process transfer from the laboratory to mass production is managed.

Sirona Biochem's compounds are being developed for both pharmaceutical and cosmetic marketplaces and are patented as new chemical entities for maximum commercial protection and revenue potential.

This is achieved by innovative clinical development of new chemical entities, most of which are derived from Grünenthal’s own pre-clinical research.

Bringing new chemical or pharmaceutical entities to market successfully asks for innovative ideas, creative researchers and modern synthesis tools that support an effective development workflow.