and constitutes the pivotal point to assume therapeutic equivalence. Physicochemical methods are preferred instead of biological assays to determine concentration of drugs in biological fluids ...

The 95% CIs of the differences between healing rates indicate that lansoprazole 30mg and esomeprazole 40mg produce equivalent healing rates of erosive oesophagitis after 4 weeks and 8 weeks of ...

In a rare move, the Food and Drug Administration told an unspecified number of generic companies that studies used to support therapeutic equivalence of some of their medicines have been rejected ...

When Momenta filed its ANDA for enoxaparin in August 2005, the challenge facing the FDA was how to demonstrate its therapeutic equivalence to Lovenox. The problem, ostensibly, is that enoxaparin ...

Chennai: Caplin Steriles Limited, a Subsidiary Company of Caplin Point Laboratories Limited, has received final approval from ...