what is a bioequivalence study and why it’s important?

It’s a study established between a generic product and an innovator (brand product).
If the two medicines are bioequivalent so there is no clinical significant difference in their bioavailability and so can be used interchangeably.
These days, the utilization of generic drug medication items increments to minimize the human services cost.
The objective of such study is to assess the remedial similarity of tried medications (generic products) to be sure for its fitness for use.

 

why icbr?

ICBR is the first center in Egypt to has GCC accredition.
Our highly experienced team is capable of delivering high quality studies in optimum time frame to our partners with suitable fees.

 

how do i prepare for a screening visit?

You should contact the responsible person who will set a screening date for you, and you should fast for at least 12 hours and should bring your valid national ID.

 

what is informed consent?

A consent form is an important document used to show that a person agrees to something that will happen.
Accordingly, the consent form is the mutual agreement between the volunteer and the Investigator to conduct a study, it also document that both parties are fully aware of all study aspects and procedures. The form should comprise explanations of the following:

•  The purpose of the study
•  The procedures involved
•  The risks and benefits of participating in the study \
•  The length of the study
•  The level of participant’s confidentiality
•  The outcome after the possible harm incurred from study by participants
•  That participation is voluntary
•  That participants are free to withdraw from the study at any time

 

how can I be eligible to participate in icbr studies?

Your age should be between 18-55 years inclusive, Body-mass index 19 to 30 kg/m2 inclusive and then your physical condition will be assessed by the attending physician.
You should have no history of alcohol or drugs abuse.

 

what is the irb?

An institutional review board (IRB), also known as an independent ethics committee (IEC).
It’s formally designated to approve, monitor, and review biomedical and behavioral research involving humans.
The number one priority of IRBs is to protect human subjects from physical or psychological harm.