Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues
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چکیده
Draft revision agreed by BMWP November 2012 Adopted by CHMP for release for consultation 13 December 2012 Start of public consultation 14 December 2012 End of consultation (deadline for comments) 30 June 2013 Draft revision agreed by BMWP April 2014 Adopted by CHMP for release for consultation 25 April 2014 Start of public consultation 30 April 2014 End of consultation (deadline for comments) 31 July 2014 Agreed by BMWP February 2015 Adopted by CHMP 26 February 2015 Date for coming into effect 01 September 2015
منابع مشابه
Draft guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human follicle stimulating hormone (r-hFSH)
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Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant erythropoietins (Revision)
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Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues
This guideline replaces 'Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues' Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues
متن کاملConcept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues
Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues
متن کاملبررسی فراوانی دیستروفی چربی ناشی از انسولین نوترکیب انسانی
Background and Purpose: Lipodystrophy is potentially a clinical adverse effect, associated with insulin therapy and is believed that usage of human recombinant insulin’s is associated with decreasing prevalence of Lipodystrophy. The objective of this study was to determine the prevalence of insulin induced Lipodystrophy, among diabetic out-patients referred to Imam Khomeini Hospital, in Sari ...
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