Everything you need to know about generic drug product development
The documents produced by the Food and Drug Administration's Critical Path Initiative focused on the difficulties involved in developing new drugs. Some specific focus areas apply to generic drug production as well. However, generic drug product development faces unique scientific challenges. The Food and Drug Administration issued a document titled "Critical Path Opportunities for Generic Drugs" in May 2007 that outlined some of the specific challenges in developing generic drugs.
The key steps of the generic drug product price!
Characterization of the reference product, design of a pharmaceutically equivalent and bioequivalent product, design of a consistent manufacturing process, and conducting a pivotal bioequivalence study are typically the key steps in generic drug product development. There are numerous opportunities where scientific advances can speed up the development and approval of generic products and broaden the range of products for which generic versions are available while maintaining high quality, safety, and efficacy standards.
These areas include applying quality by design to the development of bioequivalent products, developing more efficient bioequivalent methods for systemically acting drugs (expanding BCS exemptions, highly variable drugs), and developing new bioequivalent methods for locally acting drugs. So generic drug product development is needed.
The efficiency of generic drug products!
In contrast to new drugs, the risk of outright failure is low because the active ingredient’s safety and efficacy have already been demonstrated; however, cost efficiency is more important due to lower profit margins and competition from other manufacturers. Time efficiency is important to both generic and newer drug manufacturers, as none of the unanswered scientific questions wants to stymie generic drug product development. Another aspect of effective drug development is the use of scientific knowledge to reduce unnecessary human drug testing.
Conclusion
After the original patents expire, generic drugs can be manufactured and marketed by companies other than the innovating company. In the European Union and the United States, bioequivalence is the primary regulatory principle for generic drug approval. To be bioequivalent, two medicines must contain identical amounts of the same active ingredient in the same strength and dosage form. Their bioavailability must be similar enough that the effects can be expected to be kind of the same. There are two types of generic drug policies: supply-side policies and demand-side policies.
