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Tablets release properties alteration

Do not break or chew( XR tablets as this will alter controlled release properties... [Pg.3]

The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy, in which case additional safety and efficacy data are required. The same qualitative and quantitative composition only applies to the active ingredients. Differences in excipients will be accepted unless there is concern that they may substantially alter the safety or efficacy. The same pharmaceutical form must take into account both the form in which it is presented and the form in which it is administered. Various immediate-release oral forms, which would include tablets, capsules, oral solutions and suspensions, shall be considered the same pharmaceutical form for this purpose. [Pg.158]


See other pages where Tablets release properties alteration is mentioned: [Pg.125]    [Pg.357]    [Pg.136]    [Pg.4]    [Pg.2825]    [Pg.3950]    [Pg.567]    [Pg.141]    [Pg.335]    [Pg.340]    [Pg.159]    [Pg.263]    [Pg.579]    [Pg.122]    [Pg.118]    [Pg.335]   
See also in sourсe #XX -- [ Pg.47 ]




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