Regulatory approval, drug

PET and SPECT studies of the human brain are now widely used by the pharmaceutical industry in drug design, devdopment, and regulatory approval. Drugs that bind to neurotransmitter receptors can be labded with F- or C-, and their distribution was... 

Contracting out of activities previously only conducted in-house is already becoming quite common and will probably continue to develop. In the past a so-called full-service pharmaceutical company took direct responsibility for all the activities required for the formulation, manufacture, quality control, and regulatory approval of its drug products. Nowadays the use of specialist contract houses to perform activities such as formulation, analytical methods development, manufacture of clinical trials supplies, supervision of the assembly of an NDA, postmarketing surveillance, and even troubleshooting may be contracted for even by some of the largest companies. 

For all its promise, Big Pharma has embraced pharmacogenomics slowly and for limited purposes to this point. Though its advocates extol its potential to improve the likelihood and speed of regulatory approval as well as marketability for late-stage and market drugs, the pharmaceutical industry has not historically embraced implementation of pharmacogenomic analy-... 

When all criteria are met, the optimized lead becomes a drug candidate. Typically, one in 100 000 HTS actives reaches this stage [20]. Following approval from regulatory authorities, drug candidates proceed to clinical trials. If all three phases of clinical trials prove successful, which only one in 10 candidate drugs [21] does, the compound is approved and becomes a launched (or marketed) drug. 

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