Highlighting key points from the latest regulatory requirements, this book 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 forty respected and experience officials from regulatory agencies around the globe. It covers topics related to the development of chiral drugs, liposomal products, and more.
