Regulatory Changes

Regulatory changes and discussions of the impact of regulations on the manufacture and import of cosmetic products are available in manuals pubhshed by the CTFA (9). 

Recent evidence indicates that the 5-HT transporter is subject to post-translational regulatory changes in much the same way as neurotransmitter receptors (Blakeley et al. 1998). Protein kinase A and protein kinase C (PKC), at least, are known to be involved in this process. Phosphorylation of the transporter by PKC reduces the Fmax for 5-HT uptake and leads to sequestration of the transporter into the cell, suggesting that this enzyme has a key role in its intracellular trafficking. Since this phosphorylation is reduced when substrates that are themselves transported across the membrane bind to the transporter (e.g. 5-HT and fi -amphetamine), it seems that the transport of 5-HT is itself linked with the phosphorylation process. Possibly, this process serves as a homeostatic mechanism which ensures that the supply of functional transporters matches the demand for transmitter uptake. By contrast, ligands that are not transported (e.g. cocaine and the selective serotonin reuptake inhibitors (SSRIs)) prevent the inhibition of phosphorylation by transported ligands. Thus, such inhibitors would reduce 5-HT uptake both by their direct inhibition of the transporter and by disinhibition of its phosphorylation (Ramamoorthy and Blakely 1999). 

Finally, the category external factors consists of three parts - raw material availability, susceptibility to regulatory changes and patent protection - for which points are awarded, up to a maximum of 14 for a high VVF product. 

Hansen, R. W., "The Pharmaceutical Development Process Estimates of Development Costs and Times and the Effects of Proposed Regulatory Changes." In R.I. Chien (ed.), Issues in Pharmaceutical Economics. Lexington, MA Lexington Books (1979). 

Regulatory changes in BE requirements (that move away from the in vivo study requirements in certain cases and rely... 

Following its critique, NVAC recommended increased funding for existing public programs, regulatory changes to facilitate importation of... 

After a relatively short exposure to increased sympathetic drive, complex down-regulatory changes in the cardiac l -adrenoceptor-G protein-effector system take place that result in diminished stimulatory effects. Beta2 receptors are not down-regulated and may develop increased coupling to the IP3-DAG cascade. It has also been suggested that cardiac D3 receptors (which do not appear to be down-regulated... 

With the recent tightening of the sulfur supply situation, both in North American and worldwide, we can understand why prices increased over the past two years. It is, perhaps, less easy to understand why they expanded so rapidly. However, most of us are aware that prices can shift radically in commodity markets - both up and down - depending on supply/demand shifts, market psychology, regulatory changes, etc. The recent situation in precious metals offers a good example. 

Hansen, R., Center for Research in Government Policy and Business, University of Rochester, GPB 77-10 (1977), "The pharmaceutical development process Estimates of current developmental costs and times and the effects of regulatory changes."... 

Clear discussion of the regulatory changes in the structure of glycogen phosphorylase, based on the structures (from x-ray diffraction studies) of the active and less active forms of the enzyme. 

The association of sleep disorders with other clinical fields such as cardiology, neurology, mood and attention disorders, and pneumology is well recognized. Sleep deprivation is a medical issue, but also a social one. As a consequence, we have seen a number of societal and regulatory changes to ensure that appropriate sleep time is available. 

The proposed regulatory changes were published in the Federal Register for public review and comment before the legislation was agreed. 

---