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. The draft may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in any form or by any means outside these individuals and organizations (including the organizations concerned staff and member organizations) without the permission of WHO.

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

Loading..

Information

Related search queries