Outsourcing of Research and Development

After the discovery of a new lead compound, a pharmaceutical company needs samples (typically, in the gram to kilogram range) of the development drug for the first clinical tests, and shortly afterward, an economical and environmentally acceptable method of synthesis for the production of larger quantities. The corresponding activity is indicated as Lead Dev. in the drug development added-value chain (see the upper line in Fig. 25.9). It precedes manufacture of the NCE for clinical trials. 

As such modem tools of pharmaceutical R D as combinatorial chenfistry and rapid-throughput screening have increased the production rate of lead compounds dramatically, there is a rapidly growing dmand for the preparation of samples for NCEs and process 

The subject of outsourcing, specifically the custom manufacturing of pharmaceutical fine ehemicals, is dealt with extensively in Peter Poliak, Fine Chemicals - The Industry and the Business, Wiley, 

Peter Poliak, Fine chemicals Custom manufacturing out— API-for-generics in Speciality Chemicals Magazine, April 2003, pp. 14—16. 

Peter Poliak, in Kirk-Othmer Encyclopedia of Chemical Technology, 5th ed., Vol. 11, Wiley, New York, 2005. 

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