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QUALITY AND BIOEQUIVALENCE GUIDELINE
o Pharmaceutical development o Quality by Design o Specific types of products o Lifecycle management ... o Bioanalytical method validation, presentation of biopharmaceutical and bioanalytical data, and pharmacokinetic and clinical evaluation of modified release dosage forms
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SOUTH AFRICAN HEALTH PRODUCTS …
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www.sahpra.org.za6.01 MRF1 Medicine Registration Application (Human) - replaced by ZA-CTD . 6.02 MRF2 Screening of Application* 6.03 MRF4 Package Insert Amendments*
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Registration of Medicines Stability MEDICINES …
www.sahpra.org.zaRegistration of Medicines Stability 2.05_Stability_Jul12_v7_1 Page August 2012 1 of 27 MEDICINES CONTROL COUNCIL STABILITY This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of
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POLICY ON MANAGEMENT OF POTENTIAL …
www.sahpra.org.zaMEDICINES CONTROL COUNCIL POLICY ON MANAGEMENT OF POTENTIAL CONFLICT OF INTEREST NOVEMBER 2011. 1 INTRODUCTION. Section 6(4) of the Medicines and Related Substances Act 101 of 1965 “The ,
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