Overview

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...

Vaccines are among the most effective tools in preventive medicine, designed to prepare the immune system to recognize and combat infectious agents. By introducing antigens—substances that the immune system identifies as foreign—vaccines stimulate an adaptive immune response that leads to immunological memory. This immunological memory enables the body to mount a faster and more effective response upon future exposures to the actual pathogen.Vaccines can be categorized based on the type of...

Cancer treatment vaccines are a rapidly evolving field that offers a promising approach to immunotherapy. Unlike traditional vaccines that prevent diseases, cancer treatment vaccines are designed to treat existing cancers by stimulating the immune system to recognize and attack cancer cells.
Cancer vaccines come in two categories: preventive (prophylactic) and treatment (active). Preventive vaccines, such as the Human Papillomavirus (HPV) vaccine, protect against viruses that cause certain...

Overview

Smallpox is a severe contagious disease caused by the Variola major virus, a double-stranded DNA member of the Poxviridae family.Variola major transmission occurs primarily via inhalation of virus-laden droplets or direct contact with infectious scabs. The incubation period averages approximately seven days, although it may range from 7 to 17 days depending on the inoculum and host factors.Clinically, the prodromal phase is marked by an abrupt onset of high fever, malaise, headache, and myalgia.