Essentially a cookbook for making drugs, the six-volume handbook contains the recipes and process steps for over 2000 drugs, including a number of biotechnology drugs. The author has painstakingly assembled these volumes from FDA New Drug Applications, patent applications, and the BASF book of generic formulations, all supplemented by his 30-plus years of experience in pharmaceutical formulations. Each entry begins with a fully validated scaleable master manufacturing formula that includes the compendial specification requirement for each ingredient, process controls for manufacturing and release of the product, a summary of manufacturing process, and more.Download
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