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Annex 7 - WHO

Annex 7 - WHO

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Annex 7 133 10.3.3 Dissolution profile comparison for biowaivers based on dose- proportionality of formulations 177 10.4 In vitro equivalence testing for non-oral dosage forms 177 10.5 In vitro equivalence testing for scale-up and post-approval changes 180 References 180 Appendix 1 Recommendations for conducting and assessing comparative

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