Drug development approval

DiMasi JA. Risks in new drug development approval success rates for investigational drugs. Clin Pharmacol Ther 2001 69 297-307. 

Early identification of unique or major human metabolites can provide clear directions for testing in animals, assist in interpreting and planning of clinical studies, and prevent delays in drug development/ approval. 

DiMasi, J. A. Risks in New Drug Development Approval Success Rates for Investigational Drugs. Clin. Pharmacol. Ther. 2001, 69, 297-307. 

The data and information about an individual drug developed through Phase I, II, and III studies are extremely important to the medical community. For many drugs Phase I, II, and III data may be all, or nearly all, that is available about the clinical use of the drug at the time the product is marketed. During the time the product is in Phase I, Phase II, and Phase III, some of the compound s product and clinical data may be presented at professional meetings, published in preliminary reports, or otherwise made available to the scientific and business communities. However, it is not uncommon for a drug to be approved by FDA without the presence of its clinical research in the published biomedical literature. 

Fig. 2 Total drug development time from new drug synthesis to product approval. (From Tufts Center for the Study of Drug Development, 1998.)...

An excellent example for an enzymatic resolution process is reported for production of Pregabalin. This drug was approved by the US Food and Drug Administration (FDA) in 2004 against neurophatic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia. Several different routes have been developed based on asymmetric hydrogenation, crystallization and biocatalytic resolutions [16-20]. The most powerful and currently applied process is based on a lipase resolution, shown in Figure 14.3. This process is one of the very few... 

Several liposome-based drugs have been approved for clinical application [64]. One of the clinically approved liposomes is Doxil, a PEGylated liposome containing doxorubicin (DOX), which is used for the treatment of a number of diseases [65]. As shown in this case, in the field of liposome drug development, PEG is widely used to protect the liposome from recognition by opsonins, thereby reducing liposome clearance. 

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