Drug Safety

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 […]

ISSR is a comprehensive and detailed analysis about the safety of drugs in development. Although it is termed a summary, it includes a […]

Drug development refers to the stages of drug research and discovery that bring the newly discovered drug to the market with regulatory approval.

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 […]

Developing a new drug takes years of research and testing before it gets approved by FDA. The procedure of FDA approval is lengthy […]

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