A generic medicine is a drug defined as “a drug product that is comparable to a brand/reference listed drug product in dosage form, strength, quality and performance characteristics, and intended use. It has also been defined as a term referring to any drug marketed under its chemical name without advertising or to the chemical makeup of a drug rather than to the advertised brand name under which the drug is sold. Although they may not be associated with a particular company, generic medicines are subject to the regulations of the governments of the countries where they are dispensed. Generic medicines are labeled with the name of the manufacturer and the adopted name (nonproprietary name) of the drug. A generic drug must contain the same active ingredients as the original formulation. According to the U.S. Food and Drug Administration (FDA), generic medicines are identical or within an acceptable bioequivalent range to their brand-name counterpart with respect to pharmacokinetic and pharmacodynamic properties.
This course is divided into four major parts. The first part included an introduction to generic medicines, generic medicines’ general definitions, and the WHO with FDA definitions. The second part included the benefits of using generic medicines in the treatment of chronic illnesses regarding providing safe and cost-effective treatment. In the third part, detailed information about the quality, efficacy, and safety of generic medicines has been offered. This part focused more on bioequivalent testing and bioavailability. Lastly, part four included points to be considered regarding brand switching. Pharmacists should develop their knowledge and skills about brand switching. The major skills have been included in this part which has ended with a summary and conclusion of the topic.
Certificate of Participation
Participants will pass the online course if they got a minimum of 70% of the final quiz. Those who will meet this requirement will be given a certificate of participation.
Ramez M. Alkoudmani, Leader Pharmacist, Founder of Pharmind
Prof. Dr. Ramadan M. Elkalmi, University of Sebha
Prof. Dr. Mohamed Azmi Ahmad Hassali, Universiti Sains Malaysia
What Will You Learn?
- To describe the terms “generic medicine” and “bioavailability”
- To become familiar with concepts related to “bioequivalence testing”
- To be exposed to the concept of quality use of generic medicines
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