Drug development pathway

Innovations for the Drug Development Pathway What Is Needed Now... 

Figure B8. The Drug Development Pathway and Outsourcing Opportunities...

This description of the development of 4 provides a good illustration of the fact that the availability of an active molecule is not the end of the drug development pathway, and that formulation considerations can be critical. In this case NMR played a significant role in understanding tautomeric processes that had a direct bearing on solubility and hence on formulation. 

The QA department may reside in a special pathway reporting directly to management. There may be a corporate oversight compliance group, as well as functional groups within each drug development pathway (Scenario 1). This pathway is the more common pathway experienced by drug development firms today. 

Compared with etoposide, several synthetic compounds have shown similar or increased % inhibition of DNA topo II activity and % protein-linked DNA breakage (96), and even more notably, show increased cytotoxicity in etoposide-resistant cell lines. GL-331 (97), which contains a p-nitroaniiino moiety at the 4 position of etoposide, has emerged successfully from this preclinical development to proceed further along the drug development pathway. 

The concept of drug development is based on the findings that retinoid receptors (RARs and RXRs) offer a new approach by targeting different genes depending on the activated retinoid receptor complexes. The multiplicity of these retinoid signaling pathways affords potential for therapeutic opportunity as well as retinoid therapy associated undesired side effects. It is possible that the indiscriminate activation of all pathways by nonspecific retinoid ligands could lead to unacceptable side effects so that any enhanced efficacy would be obtained at the cost of enhanced toxicity. 

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