Transforming New Molecular Entities into Drugs

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. 

While the journey from the discovery of a drug candidate to final marketing 

Before animal testing, analytical and biological assay capabilities must be developed while the NME is being scaled up to produce a sufficient quantity with acceptable purity for use in subsequent studies. Drug standards and analytical methods for evaluating the bulk NME and the final product, as well as the tentative chemical, physical, and biologic specifications, are then established. In parallel, formulation studies are initiated to produce a stable dosage form that will provide a suitable platform for delivery of the NME in a reproducible manner. 

A drug candidate that completes pre-cUnical testing and maintains promise is then considered for evaluation in human subjects. The first step in this process is the 

COMPARATIVE DRUG DEVELOPMENT OF PROTEINS AND GENES VERSUS SMALL MOLECULES 

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