Highlighting key points from the latest regulatory requirements,
New Drug Development helps those new to the world of pharmaceutical
development understand regulatory steps, reduce cost by avoiding
unnecessary trials, and attain guidance through each step of the
drug approval process. This volume acquaints readers with
procedures that determine the success of drug development projects
with updated regulatory guidelines from the FDA and ICH, solutions
to hurdles in application protocols, and recommendations from more
than 40 respected and experience officials from regulatory agencies
around the globe. It covers topics related to the development of
chiral drugs, liposomal products, and more.
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