Drug development process, productivity

DiMasi JA. The value of improving the productivity of the drug development process faster times and better decisions. In The cost and value of new medicines in an era of change. Pharmacoeconomics 2002 20(Suppl 3) 1-10. 

The criteria used by the CBER and CDER regulators in assessing product performance during the drug development process are similar, i.e. safety, quality and efficacy. However, the administrative details can vary in both name and content. Upon concluding preclinical trials, all... 

The clinical drug development process required by the US FDA, arguably the most stringent in the world, starts with the investigational new drug (IND) application prior to human testing. It reveals information about all known compounds to be used and includes the description of the clinical research plan for the product as well as the protocol for phase I studies. Preclinical study results also need to be revealed. 

For reasons of space we will not discuss the development of the production process nor that of the formulation and presentation form. The reader should appreciate, however, that this is a major part of the overall drug development process, subject to the highest quality requirements and a key factor in the regulatory approval and medical and commercial success of the drug. 

To gain FDA approval or license for marketing, a pharmaceutical product must be shown to be safe and effective for its proposed or intended use. The drug company or sponsor must also provide evidence to show that the processes and control procedures used for synthesis, manufacture, and packaging are independently validated to ensure that the pharmaceutical product meets established standards of quality. The overall effort from the inception of a new molecular entity and the establishment of analytical, scale-up, and quality control procedures, to the collection of safety and efficacy data for consideration by the FDA as part of an NDA or BLA, is called the drug development process. 

The ICH was established in 1990. Its main aim is to improve the efficiency of the drug development process and the registration of new drug products in its member countries through harmonization of national guidelines. This is a joint initiative... 

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