MULTISOURCE (GENERIC) PHARMACEUTICAL PRODUCTS: …
Working document RESTRICTED WORLD HEALTH ORGANIZATION ORGANISATION MONDIALE DE LA SANTE MULTISOURCE (GENERIC) PHARMACEUTICAL PRODUCTS: GUIDELINES ON REGISTRATION REQUIREMENTS TO ESTABLISH INTERCHANGEABILITY DRAFT REVISION The World Health Organization acknowledges with the thanks the input of the following FIP/WHO BCS Task Force members: Kamal K. Midha, Vinod P. Shah, Gordon Amidon, Dirk Barends, Jennifer Dressman, John Hubbard, Hans Junginger, Rabi Patnaik, James Polli, Salomon Stavchansky. ________________________________________ _____________________________________ World Health Organization 2005 All rights reserved. This draft is intended for a restricted audience only, the individuals and organizations having received this draft.
Working document QAS/04.093/Rev.4 page 5 classes of product, including - most evidently - parenteral formulations of highly water soluble compounds, interchangeability is adequately assured by implementation of GMP and evidence of
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