Bio-Equivalence Studies are required by the U.S. Food and Drug Administration & the European Medicines Agency before they will authorize a drug to be sold either in the U.S. or the E.U. When an original drug which has been marketed for 20 or more years, by the originating drug manufacturer goes off patent, any pharmaceutical manufacturer can begin to manufacture and market that same drug. However, before they are permitted to manufacture and sell it, they must do a Bio-Equivalence Study.
The Study compares two versions of the same drug, the generic and the name brand (the original). The purpose of the study is make certain that the generic reacts the same way as the original by measuring the amount of the drug in a persons blood over a period of time.
The Study Procedure in Brief
Recruiting healthy Study Subjects between the ages of 18 and 45 years old,
Screening the Study Subjects, which includes a complete physical examination, to make sure that they are healthy and qualify for participation,
A presentation to the participants fully explaining, answering all questions, completing an Informed Consent Form and an Agreement,
The participants will come to the Research Center Friday evening and stay for the length of the Study (usually Friday eve to Sunday evening or Monday morning). All food and nurishment will be supplied by Darmantest Laboratories.
The medicine will be taken by the participants Saturday morning, followed by blood samples being taken as prescribed by the protocol. Half of the participants will take the Generic drug and the other half the Original Name Brand.
At the end of the 2 or 3 days all participants will go home and return the following Friday evening to repeat the same procedure, but, those who took the Generic drug will now take the Original Name Brand and vice versa.
At the end of the second period all participants will be given a final physical examination, go home and be paid for their services within a few days.
DTL's Chemists now begin their analysis of all the blood samples, the final report will be prepared and submitted to the Sponsor, who in turn will submit the report to either the U.S. Food and Drug Administration or the European Medicines Agency.
Restrictions During Participation
During the Study and your stay at the Research Center we try to make everyone as comfortable as possible, however, for safety reasons and to prevent inaccurate test results, there are a few important restrictions that the Study Subjects must agree, and adhere to before they will be accepted as a participant.
No one may smoke.
No one may drink - alcoholic beverages, caffeinated coffee, tea or carbonated beverages.
Women who are pregnant are not eligible to participate.
No one may take any medicines or vitamins without prior approval of the Clinical Investigator.
Safety and Precautions
Before any applicant is accepted as a Study Subject he or she must undergo and pass a physical examination. This includes, but is not limited to:
Medical History - Physical Examination - Vital Signs - ECG - Chest X-ray - Blood and Urine analysis
At Darmantest Laboratories our first priority is the safety of the Study Subjects. From the development of the study design to the final study report we very strictly adhere to the ethical and safety precautions outlined by the U.S. Food and Drug Administration or the European Medicines Agency and approved by an Independent Review Board / Ethics Committee.
In addition to a staff of more than eight physicians and a dedicated Medical Investigator for each study, our team of experts, includes, but is not limited to our Quality Assurance Manager, our Monitors, our team of Chemists and our Statisticians all of whom ensure that the study is properly carried out and completed.
DTL's entire staff is trained in and adheres to Good Clinical Practice (GCP). Our laboratory and analytical staff is trained and adheres to Good Laboratory Practice (GLP) and Good Documentation Practice (GDP). Each of our departments works independently of each other in order to prevent influencing any analysis, or the final report results.