Transcription of MULTISOURCE (GENERIC) PHARMACEUTICAL …
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MULTISOURCE (GENERIC) PHARMACEUTICAL …
Working document July 2014 Document for comment 1 2 MULTISOURCE ( generic ) PHARMACEUTICAL 3 PRODUCTS: GUIDELINES ON REGISTRATION 4 REQUIREMENTS TO ESTABLISH 5 INTERCHANGEABILITY. REVISION 6 (JULY 2014) 7 8 REVISED DRAFT FOR COMMENT 9 10 11 World Health Organization 2014 12 All rights reserved. 13 This draft is intended for a restricted audience only, the individuals and organizations having received this draft. 14 The draft may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or 15 in whole, in any form or by any means outside these individuals and organizations (including the organizations' 16 concerned staff and member organizations) without the permission of the World Health Organization.
Working document QAS/14.583/Rev.1 page 4 66 • Additional guidance for organizations performing in vivo bioequivalence studies 67 Annex …
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