Drug development quality, importance

Poor pharmacokinetics and toxicity are important causes of costly late-stage failures in drug development. It is generally recognized that, in addition to optimized potency and specificity, chemical libraries should also possess favorable ADME/Tox and druglike properties [77-80]. Assessment of druglike character is an attempt to decipher molecular features that are likely to lead to a successful in vivo and, ultimately, clinical candidate [81-83]. Many of these properties can be predicted before molecules are synthesized, purchased, or even tested in order to improve overall lead and library quality. 

Pharmaceutical innovation has made a decisive contribution to the reduction of mortality and the improvement of quality of life. The role of patents in providing incentives for innovation has been crucial. Yet at the same time there are limitations that need to be overcome in the future. Here we will mention just two examples orphan drugs and parallel imports. Patents do not offer incentives to develop drugs for low-prevalence diseases, known as orphan drugs. Governments are sometimes faced with the option of public production, as the private sector does not invest in them. Yet these would be precisely the cases in which experiments would be conducted with new models for promoting innovation, as discussed in this chapter. 

Evaluation of the dissolution rates of solid drugs is extremely important in the development, formulation, and quality control of solid pharmaceuticals. The... 

In pharmaceutical development, technology transfer from laboratory scale towards industrialization is generally considered as a critical step. It is therefore necessary to anticipate during laboratory scale studies changes which may occur in drug product quality during scale up. To do so, it is important to identify and control the drug product characteristics (for instance particle size, crystalline form,.. ) which may affect its performances (such as dissolution kinetics, compressibility,...). 

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