Medical countermeasures are biological products used to counter threats to public life that include a chemical or biological or even nuclear component. Terrorist […]
Post-authorization safety studies are the term used by the European Medicines Agency (EMA), the nodal clinical research regulator in Europe, to define those […]
For the undiscerning, biosimilars in pharmaceuticals may sound like pharmaceutical generics, but they are different. The major difference is that biosimilars are manufactured, […]
Pharmacovigilance or drug safety is the discipline in clinical research that deals with assessing, monitoring, and reporting whether pharmaceutical products being tested for […]
What is Pharmacogenomics It is that field of scientific study where pharmacology and genomics combine to discover the responses of an individual to […]
Microbiological methods are used for detection of microbial organisms in processes and procedures that require a sterile environment free of microorganisms. The procedures […]
Drugs that are not approved by authorities like FDA and other federal authorities are considered unapproved drugs. FDA checks for the effectiveness and […]
The organ-on-chip technology is a customizable chip that has inbuilt facilities to enable the mimicking of the responses of organs or organ systems […]
Patient safety in clinical trials has become prominent in the priorities of clinical research organizations (CRO) and other sponsors. In lieu of this […]
Preclinical development processes for biopharmaceutical products refer to drug discovery, drug research and experimental testing on life forms other than humans that occur […]
Drug safety or pharmacovigilance, as it is formally termed, is the field of science that is responsible for assessing, identifying and recording the […]
According to the food and drug agency (FDA), sterile drug products are manufactured by two methods. They are terminal sterilization and aseptic processing. […]