Reverse engineering: Researchers produce a new drug or chemical agent by developing a new production process that is different from an already invented (and patented) production process. Reverse engineering is possible in countries where patent laws protect only the pharmaceutical process and not the product.
When making generic drugs, inspection is very important, such as the appearance, color, coating, size, whether there are nicks, etc. of the original product. But we cannot just rely on inspection, we also need scientific analysis methods to help us. Gain a deeper understanding of the prescription information, process information, dissolution information, impurity information, stability information, etc. of the original research product.
When making generic drugs, the reference drug is your target. To achieve both pharmaceutical and biological equivalence, you need to conduct quality profile and prescription analysis of the reference drug. These are all reverse engineering. .
There is no specialization in reverse engineering of preparations. Let’s learn the preparation technology itself.