National Research Centre

Medical Research Ethics Committee

MREC Reviewer Comment

Protocol Title

Development and Evaluation of Ciclopirox Olamine–Loaded Vesicles for the Treatment of Otic Infections

Completely satisfied and informative data

Needs Explanation

Comments to the applicant

·         Protocol Title in English: Development and Evaluation of Ciclopirox Olamine–Loaded Vesicles for the Treatment of Otic fungal  Infections

Protocol Title in Arabic

تطوير وتقييم الحويصلات المحملة بدواء سيكلوبيروكس أولامين لعلاج عدوى الأذن الفطرية

·         Please complete principal investigator  data ( Institute &Department ).

·         Duration of study should be all the procedure of the protocol not the duration of the experiment.

·         It should be mention funding agent and fund amount

·         Hypothesis, Rationale and Scientific Validity are written as the back ground .But  the  summary at the end of background is written

·         In the procedure in details  describe all procedure of the study; especially of nanopartical and Nano vesicles drug formula in addition of species &specification of rats

·         Animal groping in the procedure in details  is written ( after infection, the animals will divided into 6 groups), but  5 groups only are infected and six group used as control negative without infection   

Comment to the Committee

·         Protocol Title in English: Development and Evaluation of Ciclopirox Olamine–Loaded Vesicles for the Treatment of Otic fungal  Infections

Protocol Title in Arabic

تطوير وتقييم الحويصلات المحملة بدواء سيكلوبيروكس أولامين لعلاج

عدوى الأذن الفطرية

·         Please complete principal investigator  data ( Institute &Department ).

·         Duration of study should be all the procedure of the protocol not the duration of the experiment.

·         It should be mention funding agent and fund amount

·         Hypothesis, Rationale and Scientific Validity are written as the back ground .But  the  summary at the end of background is written

·         In the procedure in details  describe all procedure of the study; especially of nanopartical and Nano vesicles drug formula in addition of species &specification of rats

·         Animal groping in the procedure in details  is written ( after infection, the animals will divided into 6 groups), but  5 groups only are infected and six group used as control negative without infection   

Protocol Title in Arabic :

Informed consent form:

N/A

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