Posted on November 11, 2019
A bioequivalence study is a study conducted to show those two different drugs, or two different dosages of the same drug. It absorbed in the same way and produces the same effect on the required site. For general medicinal products, the concept of bioequivalence is important because bioequivalence with the (original) reference medicinal product must be confirmed before a basic product can be approved. Regulatory authorities charge bioequivalence by considering two standards: the speed of absorption and the extent of absorption. If one or both parameters are different in the formulation of a drug, the authorities will determine that the drug is not bioequivalent to the product of origin.
Bioequivalence studies in humans
Bioequivalence study is designed to compare in vivo behavior from a multisource drug to that of the reference medicine. Often, the product to be estimated and the reference product are administered successively to volunteers with an appropriate interval between the two. This interval is chosen so as to ensure the complete elimination of the drug during the first treatment before the supervision of the second treatment. Blood and urine samples are taken just previous to supervision and at appropriate intervals thereafter for the resolve of the active ingredient and one or more metabolites. The pattern of these concentrations over time in each subject of the study provides an indication of how the substance is released by the product to be assessed and its uptake into the body. To compare the two products, concentration curves are drawn in the blood (including plasma or serum) or urine. The results obtained for each subject are subjected to a statistical analysis.
Products under bioequivalence study
Samples of a drug submitted for bioequivalence for registration must be identical to the product being marketed. In addition to the composition and quality characteristics (including stability), the manufacturing methods must be identical to those that will be applied during normal production.
Ideally, samples should be taken from lots produced on an industrial scale. If this is not possible, pilot or small scale production batches may be used provided their size is not less than 10% of that of normal production batches.
It is recommended that the activity and in vitro dissolution characteristics of the product to be evaluated and the reference product be determined before proceeding with the equivalence study. The active ingredient contents of both products should not differ by more than 5%. If the activity of the reference product is more than 5% from the declared quantity, this difference may be consider later to standardize the results of certain dose-related bioavailability parameters.
- Understand the concepts of bioavailability and bioequivalence
- Know when and how to perform bioavailability and bioequivalence studies
- Identify the key points of this type of study
- Discover the usual problems encountered during the implementation of these studies
- Know how to interpret the results and the statistical analyzes
- To be able to apprehend the admissibility, by the regulatory authorities, of the studies carried out.
Updated on October 19, 2018
Temporary resident visa is the minimum requirement that a person needs to have to work in Canada even if he is eligible to work without a work permit. So, let’s know all about Canada Immigration medical exam. Following are the cases in which a person of foreign nationality can work in Canada without a work permit:
Foreign Government Officers
Canada permits the exchange of Government Employees who are recruited to either work for a department or an agency under federal or provincial government. These individuals do not work under foreign mission or organization nor are appointed by the Department of Foreign Affairs or International Trade (DFAIT).
Civilian Personnel in Canada under the Visiting Forces Act may work and study without permits in Canada. Their families are covered by this exemption, they require a passport, temporary resident visa, and foreign national medical examination.
Foreign Representatives and family members
Foreign Representatives and family members can work in Canada without a work permit but must be approved by Department of Foreign Affairs and International Trade and have a ‘no objection letter’ by the same if not having a work permit.
Business Visitors is an umbrella term and covers those of foreign nationalities who come to Canada for business activities. They can be categorized as – sales service providers in industrial and commercial areas, businessmen who come for business meetings, and short-term full-time employment.
American Cross-Border maritime law Enforcement Officers
American and Canadian crew members work as a troupe on both on US/Canada border. When in which country they fulfill that country’s work authorization.
There are many performing artists who go to Canada to perform on particular shows. Most of them perform without a work permit but there are some who require a Labour Market Impact Assessment (LMIA) or work permit like singers, actors of film and theatrical background.
A student who is holding a valid study permit and is a full-time student at a particular institution is eligible to work in the premises of that campus.
In flights security officers
Those who are employed by foreign governments to enforce safety on foreign aircraft with a Canada work permit.
Athletes and sports person
Athletes and Sportsperson who go to Canada to participate in certain sports activities will need a Canada Immigration Medical Exam.
News reporters and public speakers
News reporters and public speakers can come to the country to report certain events and or address seminars provided they are not working for a Canadian entity.
Judges and referees
Judges and referees who come to participate in professional sports events must receive an LMIA and work permit. Clergy who come for religious services or preachers or counselors may practice without a work permit.
Convention organizers, performers or event coordinators who work for Canadian event may not do so without a work permit.
Professors, Examiners, and Researchers
Examiners, professors or Researchers who come to Canada for the completion of theses or project may do so without a work permit.
For the inspection and investigation of commercial international flights by flight operations and safety, inspectors do not need work permit provided they are employed by a recognized aeronautical authority and similar valid documentation will Canada Immigration Medical Exam.
Emergency Service providers
Emergency Service providers may work without a work permit when entering in case of emergency. Individuals working under a work permit may continue to work even if the work permit expires but they should apply for a new one before the original expires.