Unlike generic medicines where the active ingredients are identical, biosimilars – by definition – are not likely to be identical to the originator biologic. They are similar, but not the…

Oral dissolving film is a new drug delivery system for oral delivery of drug. It has gained popularity due to its availability in various size and shape. The concept of…

Gene therapy is a process in which exogenous genetic material is transferred into somatic cells to correct an inherited or acquired gene defect. Also, it is intended to introduce a…

A radiopharmaceutical is a radioactive pharmaceutical agent that is used for diagnostic or therapeutic procedures. For a product to be classified as a radiopharmaceutical agent safe for human use, the…

Microencapsulation is a process of encapsulating microscopic drug particles with a special coating material, therefore making the drug particles more desirable in terms of physical and chemical characteristics.

A dosage form that releases a discrete portion or portions of drug at a time or at times other than promptly after administration, although one portion may be released promptly…

Process validation is the process for establishing documented evidence to provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and

Biopharmaceutics is the study of the in-vitro impact of the physicochemical properties of drugs and drug products on drug delivery to the body under normal or pathologic conditions. A primary…

In the United States, the Food and Drug Administration (FDA) regulates the development of new drug products and their subsequent marketing. One of the FDA’s functions is to promote and…