Process chemistry clinical phase

Like the process chemistry modifications and formnlation development, the nonclinical evalnation process continnes well past the IND enabling phase. Additional preclinical evalnation will be necessary. For example, if human beings of reproductive age will be treated by the drug, reproductive toxicology will be necessary before an NDA can be filed, and if the drug is to be dosed chronically, carcinogenicity studies will be required. The nonclinical evaluation process continues throughout the clinical development. 

However, compared with the traditional analytical methods, the adoption of chromatographic methods represented a signihcant improvement in pharmaceutical analysis. This was because chromatographic methods had the advantages of method specihcity, the ability to separate and detect low-level impurities. Specihcity is especially important for methods intended for early-phase drug development when the chemical and physical properties of the active pharmaceutical ingredient (API) are not fully understood and the synthetic processes are not fully developed. Therefore the assurance of safety in clinical trials of an API relies heavily on the ability of analytical methods to detect and quantitate unknown impurities that may pose safety concerns. This task was not easily performed or simply could not be carried out by classic wet chemistry methods. Therefore, slowly, HPLC and GC established their places as the mainstream analytical methods in pharmaceutical analysis. 

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