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
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
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.
INVESTIGATIONAL MEDICINAL DRUG PRODUCT (IMDP) - DOCUMENTS
1._description-and-composition.pdf
2._pharmaceutical-development.pdf
6._manuf-process-and-controls.pdf
10._validation-analytical-procedures.pdf
12._characterisation-impurities.pdf
13._justification-of-specifications.pdf
14._reference-standard-or-materials.pdf
15._container-closure-system.pdf