This review summarizes the methods used to study real-time (37?C) drug release from nanoparticulate drug delivery systems and\nestablish an IVIVC. Since no compendial standards exist, drug release is currently assessed using a variety of methods including\nsample and separate (SS), continuous flow (CF), dialysis membrane (DM) methods, and a combination thereof, as well as novel\ntechniques like voltametry and turbidimetry.This review describes the principle of each method along with their advantages and\ndisadvantages, including challenges with set-up and sampling. The SS method allows direct measurement of drug release with\nsimple set-up requirements, but sampling is cumbersome.With the CF method, sampling is straightforward but the set-up is time\nconsuming. Set-up as well as sampling is easier with the DM, but it may not be suitable for drugs that bind to the membrane.\nNovel methods offer the possibility of real-time drug release measurement but may be restricted to certain types of drugs. Of these\nmethods, Level A IVIVCs have been obtained with dialysis, alone or in combination with the sample and separate technique. Future\nefforts should focus on developing mathematical models that describe drug release mechanisms as well as facilitate formulation\ndevelopment of nano-sized dosage forms
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