Drug development essential characteristics

It may be envisioned that a protocol for the complete physical characterization of a solid material could easily be developed. At the early stages in drug development, each lot of active drug, excipients, and formulated blends would be characterized as fully as possible. A feedback loop would be established after each formulation run, in which the physical characteristics of the input materials were correlated with the quality of formulated product. Out of these studies would come an understanding of what particular properties were essential to the production of an acceptable formulation. 

Drug development is ideally a logical, step-wise procedure in which information from small early studies is used to support and plan later larger, more definitive studies. To develop new drugs efficiently, it is essential to identify characteristics of the investigational drugs in the early stages of development and to plan an appropriate development based on this profile. 

The comprehensive profile of drug substances and pharmaceutical excipients as to their physical and analytical characteristics continues to be an essential feature of drug development. The compilation and publication of comprehensive summaries of physical and chemical data, analytical methods, routes of compound preparation, degradation pathways, uses and applications, etc., is a vital function to both academia and industry. It goes without saying that workers in the field require access to current state-of-the-art data, and the Analytical Profiles series has always provided information of the highest quality. For this reason, profiles of older compounds are updated whenever a sufficient body of new information becomes available. 

Validated bioanalytical assays are essential and have to be developed to characterize the biopharmaceuticals during the production process (e.g. in-process control) and to release the final product for use as a drug in humans. These assays are applied to determine characteristics such as purity/impurities, identity, quantity, stability, specificity, and potency of the recombinant protein during drug development. Since the very diverse functions of different proteins heavily depend on their... 

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