The drug discovery and development process is an indispensable part of typical research-based pharmaceutical company. At each stage, there will be several activities running in parallel, with the overall objective of discovering a candidate drug and developing it to market as efficiently as possible. At the early stages of formulation optimization, pre-formulation studies are usually conducted to screen excipients or packaging materials and to select those compatible with the candidate drug, using accelerated stress-testing procedures. The final stage of formulation optimization will normally involve generating sufficient stability data on one or more variants to select the best variant. The optimal product will usually be selected on the basis of technical merit. The manufacturing process used during product optimization should be designed with large-scale manufacture in mind. Ideally, the process should be as representative as possible to the eventual commercial-scale manufacture.
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