Drug Safety

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. […]

When a healthy volunteer/patient suffers a negative health reaction to a drug being tested in clinical trials, an adverse event is reported and […]

When a patient/volunteer being administered a drug under clinical trials or outside trials in the case of a treatment regimen, undergoes an adverse […]

The FDA aims to protect the health of U.S citizens’ by assuring them safe and secure drugs as well as biologics. However, the […]

The term biosimilar refers to a pharmaceutical drug that is similar to an originally approved biological product with significant differences in safety and […]

There are different phases of developing a new drug. The first phase is a preclinical phase. The duration of this phase lasts for […]

Clinical trials are a part of drug safety procedures for new as well as current drugs that are on sale. This helps to […]

Process Analytical Technology (PAT) is a standard mechanism used by Food and Drug Administration (FDA) to regulate and maintain standards in the process […]

The process of creation of a drug to getting it in a market place is a lengthy process. Every process, right from the […]

The basis of this profile is to keep an eye on the safety measures of the drugs that enter the market. The evaluation […]

The role of a drug safety associate is very unique. Generally the drug safety associates work in a team, with each one having […]