What are the uses of bioequivalence study and process chemistry?


During the last four decades, there is increased use of generic drugs to lower the healthcare cost. The most appropriate method of ensuring therapeutic equivalence between two medicinal drugs is Bioequivalence. It is the property by which, two drugs with identical ingredients or two different dosage forms of the same drug possessing similar bioavailability producing the same effect at the site of physiological activity. In other words, it can be explained as if two drugs having similar properties, its purpose is considered to be the same.

Bioequivalence study

A bioequivalence study should be conducted for comparing the medicinal products containing the same active substance. Such studies need to be carefully designed to take into account biopharmaceutical, ethical, medical, pharmacokinetics, analytical and statistical considerations. These studies should be used to assess the possibility of alternate use of bioequivalent products. 

The study of both Bioequivalence and bioavailability are important during drug development of both new drug products and their generic equivalents. Provision of bioavailability and bioequivalence study data is an important element in support of Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs) and their supplements. 

The term generic drug product has been defined as an interchangeable multi-source pharmaceutical product. Generic products are copies of brand-name drugs with the same dosage form, strength, route of administration, intended use, and toxicity profile as the original innovator drug.

Process chemistry

Process chemistry is the area where most of the effort of incorporating green chemistry has been achieved to date. The major responsibility of process chemistry is to develop practical, safe and cost-effective processes for the synthesis of compounds selected to progress from research to a larger scale. They generally work on a single target molecule and define the best route to the target. 

Process chemistry scales up reactions taking them from small quantities to larger quantities that are needed for testing and then convert them into even larger quantities because some impurities cannot be identified in smaller quantities. Process chemistry requires a blend of both theoretical and practical knowledge. For the desired result, one must always keep the cost and safety in mind and design accordingly.

Duties of Process chemists

  • They work on products along the development chain whose product value in the market is high.
  • They develop a great deal of satisfaction as they have helped to develop the product.
  • They develop synthetic plans and designs to test their suitability for large scale use.
  • They use a variety of methods to monitor the reaction process of the product.
  • They help in troubleshooting the existing process and find the best solution for future purposes.
  • They use a variety of design experiments to change multiple variables simultaneously and identify acceptable ranges of all the operational parameters.
  • They help in improving the existing processes to reduce the cost and increase reliability and safety.

The research chemist may discover a compound that has amazing properties, but process chemistry is the field where one can turn that compound into a useful product.