Special drug application

In the case of special drug applications, para-venous testing has to be conducted to check for possible risks of drags being erroneously administered into the paravenous tissue. The animals receive an acute administration lateral and medial of the V. j ugularis sinistra of each... 

The CDER drug review team members apply their individual, special technical expertise to review INDs or new drug applications. 

The reorganization of the CPAC was decided in November 1999 shown above to aim more speedy, sufficient and efficient review, and to shorten the review time to 12 months. The major change in the reorganization is a decrease of subcommittees from 62 to 16 and revision of the role of each special committee. The new CPAC consists of 18 special committees and 16 subcommittees. Consequently the Evaluation Center of NIHS has more important role for the review of new drug applications until the delivery to special committee. 

There is a special patent infringement remedy for a patent owner when a party files an Abbreviated New Drug Application (" ANDA") or a "paper NDA. Both ANDAs and paper... 

There are a number of studies in which liposomes were compared to lotion, creams, or penetration enhancers. Although information can be obtained about the relative effectiveness of liposomes compaied to other formulations, no information can be obtained about mechanisms, since in lhc.se studies the thermodynamic activity of the drug in the various formulations might differ quite extensively. Furthermore, the different components in the liposome.s and lotions or creams might have different interactions with the skin. Therefore, obtained differences in drug penetration rate cannot be correlated with the special shape of the lipo.sumes. Nevertheless, these studies are of interest becau.se they show whether or not drug application in liposomes will be in favor compared to other formulations that might already be on the market. 

For biomedical purposes, considerable research has been done in the area of hemicelluloses due to the biocompatibility, biodegradability, and high stability of these compounds. Many hemicelluloses are already widely used in the pharmaceutical industry, while others are as yet relatively unexploited. More specialized drugs and methods of drug delivery will be necessary to fulfill requirements, as progress in the pharmaceutical industry leads to increased demands on materials for specific applications. Lots of hemicelluloses are already commonly used in this field, and other less investigated hemicelluloses may find application in the future. ... 

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