The Name Brand (Original) drug is a drug that is patented, manufactured and sold by the original manufacturer.
Who is eligible to participate?
Participation in a Bio-Equivalence Study is very carefully controlled. Only healthy men and women between the ages of 18 and 45 years old may participate in a Study.
Prior to being accepted as a Study Participant, the individual will undergo a complete physical examination.
Amongst other things, the participant may not be:
Overweight, have high or low blood pressure, have a history of tuberculosis, epilepsy, asthma, diabetes, psychosis, glaucoma, etc. In addition a woman cannot be pregnant.
What is included in the physical examination?
The complete physical examination includes, but is not limited to:
Review of your medical history - Vital Signs - ECG - Chest X-ray - Blood & Urine analysis - Respiratory examination - eyes, ears, nose and throat, etc.
How much medication do I have to take?
Since a bio-equivalence study is only meant to measure the duration of the drug within the blood system, and does not attempt to cure any illness, generally, you are required to take 1 pill (on occasion possibly 2, depending upon the specific drug) at the beginning of each period. The dosage will depend upon what is required for that particular study.
Are the drugs that I will be taking safe?
The drugs that are studied during Bio-Equivalence Studies are drugs that have been prescribed and sold internationally for a minimum of approximately 20 years and are considered safe. However, just as with any medication there are some people that may react differently to a specific drug. Safety is our first priority and we take all precautions beginning with the screening process to the end of the study to make sure that all participants are as safe as possible. If there is any indication that someone may have a problem during the study they will not be accepted, or if already accepted, will be withdrawn from the study.
What if I have an adverse reaction?
We require all Study Participants to advise the Nurses or Doctors if they have any unusual reactions during the study. At that time the Doctor (s) will examine the individual to determine whether their reactions are due to the medication or not. Depending upon the circumstances, the severity and its relation to the medication, all steps will be taken to resolve the problem.
Who pays for any medical costs due to Adverse Effects?
Upon determining the cause of the Adverse Effect, if it is due to the medication used in the study, all medical expenses will be paid for by the Sponsors insurance company.
What are Monitors?
Documentation, evaluation and recording of everything that we do is of the utmost importance. Therefore, we require all procedures to be monitored. The monitors, who are either Doctors, Nurses or specially trained individuals, oversee each procedure, record what is being done and then review and document it all.
What is meant by Quality Assurance?
Quality Assurance is the systematic monitoring in compliance with U.S. Food and Drug Administration and European Medcines Agency regulatory standards. Our high quality standards and careful evaluation of each step of the entire Study, ensures that all studies are conducted properly and in compliance with the requirements of the regulatory agencies.
Who has approved these Studies?
There is a lengthy process and a great deal of preliminary preparation prior to receiving final approval to conduct a Bio-Equivalence Study.
A Protocol is prepared and presented to the Sponsor, upon their approval an application, including all of the required documentation is presented to the Ministry of Health of the Republic of Armenia, who in turn presents it to the MOH Ethics Committee. Independent of the MOH we are required to present the same documentation to an Internal Review Board, who is obligated to follow the guidance of the U.S. Food and Drug Administration and /or the European Medicines Agency. Upon receiving approval of all of these organizations we are permitted to conduct the Study.
What is Good Laboratory Practice (GLP)?
In the non-clinical research laboratory, the phrase Good Laboratory Practice (GLP) specifically refers to a quality system of management controls for research laboratories and organizations to try to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemicals or pharmaceuticals. All of DTL's Chemists and laboratory employees are required to be trained and follow GLP.
What is Good Clinical Practice (GCP)?
Good Clinical Practice (GCP) is an international quality standard that is provided by the International Conference on Harmonization (ICH) that defines standards, for governments to use as regulations for clinical studies.
Good Clinical Practice Guidelines are the standards by which our studies are conducted; they define the roles and responsibilities of study sponsors, clinical research investigators, and employees. In addition it protects the subjects human rights and provides assurances for safety and efficacy.
What is Good Documentation Practice (GDP)?
Good Documentation Practice (GDP) is the term that the pharmaceutical industry uses to describe the standards by which documents are created and maintained.
Frequently Asked Questions
What is a Bio-Equivalence Study?
Very simply, a Bio-Equivalence Study measures the amount of a drug in a persons blood over a period of time. The purpose of the study is to compare two of the same drugs, the Generic version to the Brand Name Drug to be certain that they are the same.
What is a Generic Drug?
It is a copy of a brand-name (original) drug that can be manufactured by another drug manufacturer after the patent for the original drug has expired. The Generic is the same dosage, safety, strength, route of administration, quality, performance and intended use.
What is a Brand-Name (Original) Drug?