IVERCOV kutatás-fejlesztés

A kutatás szakmai vezetője - Dr. Ragó Zsuzsanna

 

Magyar Generikus Gyógyszerfejlesztés (nem Covid vizsgálat) : 

Prof Dr. Bácskay Ildikó Debreceni Egyetem - kapcsolattartó

Prof. Dr. Páll Dénes - Bioekvivalencia vizsgálatok vizsgálatvezetője

Prof. Dr. Kovács Péter - Bioekvivalencia vizsgálatok szakmai tanácsadója

 


 

Koterlán Dávid-Prof.dr Bácskay Ildikó -Ivermectin tartalmú innovatív készítmények fomulálása és vizsgálata 

 



 

ELSŐ MÉRFÖLDKŐ
 
Letölthető dokumentumok:
-Ivermectin - MEDITOP protokol
-IMPD Ivermectin tablets
-Stromectol ivermectin 3mg és ivermectin placebo tabletta klinikai vizsgálat
 


 

Hírek
 

Database of all ivermectin COVID-19 studies. 72 studies, 35 peer reviewed, 46 with results comparing treatment and control groups.


Merck’s Stromectol (Ivermectin) Used in Hungarian Clinical Trial Targeting Mild COVID-19 Cases During Worst Pandemic Spike in Eastern Europe

Merck’s Stromectol (Ivermectin) Used in Hungarian Clinical Trial Targeting Mild COVID-19 Cases During Worst Pandemic Spike in Eastern Europe

Earlier this month, the Eastern European nation of Hungary’s National Institute of Pharmacy and the European Medicines Agency authorized a clinical trial using Merck’s Stromectol, a brand of ivermectin in a clinical trial targeting mild COVID-19 cases here. The sponsor of this study now, Meditop Pharmaceutical Ltd., targets 70 participants for this randomized, double-blind, placebo-controlled study to assess the safety and efficacy of ivermectin in asymptomatic and mild severity COVID-19 patients. It is also supported by contract research organization (CRO) Cortex Pharma Services. Conducted at three (3) trial site locations, the study is planned to commence for a few months and occurs in the middle of the worst pandemic spike this nation has yet experienced. Hungary’s rate of COVID-19 infection has doubled since its worst spike in November due to the UK variant of SARS-CoV-2.

read more...

forrás: Trial Site News

 

 



INVESTIGATIONAL MEDICINAL DRUG PRODUCT (IMDP) - DOCUMENTS

 

1._description-and-composition.pdf

2._pharmaceutical-development.pdf

3._batch-formula.pdf

4._control-critical-steps.pdf

5._manufacturers.pdf

6._manuf-process-and-controls.pdf

7._specification.pdf

8._specification.pdf

9._analytical-procedure.pdf

10._validation-analytical-procedures.pdf

11._batch-analysis.pdf

12._characterisation-impurities.pdf

13._justification-of-specifications.pdf

14._reference-standard-or-materials.pdf

15._container-closure-system.pdf

 

Legutóbbi frissítés: 2022. 08. 08. 15:22