Drug Safety

March 1, 2017

Importance Of Documentation In Approaches To Safety Signaling!

Safety signaling is a term that is used specifically in the pharmacovigilance field. There hasn’t been a unanimous definition of the term and […]
February 20, 2017

The FDA’s Medical Countermeasures Initiative (MCMI)

Medical countermeasures are biological products used to counter threats to public life that include a chemical or biological or even nuclear component. Terrorist […]
February 1, 2017

Post Authorization Safety Studies!  (PASS)

Post-authorization safety studies are the term used by the European Medicines Agency (EMA), the nodal clinical research regulator in Europe, to define those […]
January 27, 2017

An Update: Pharmacovigilance And Risk Management For Biosimilars!

For the undiscerning, biosimilars in pharmaceuticals may sound like pharmaceutical generics, but they are different. The major difference is that biosimilars are manufactured, […]
January 17, 2017

How To Begin A Career In Drug Safety!

Pharmacovigilance or drug safety is the discipline in clinical research that deals with assessing, monitoring, and reporting whether pharmaceutical products being tested for […]
January 16, 2017

Pharmacogenomics!

What is Pharmacogenomics   It is that field of scientific study where pharmacology and genomics combine to discover the responses of an individual to […]
January 9, 2017

What Are The Rapid Microbiological Methods?

Microbiological methods are used for detection of microbial organisms in processes and procedures that require a sterile environment free of microorganisms. The procedures […]
January 5, 2017

What are Unapproved Drugs?

Drugs that are not approved by authorities like FDA and other federal authorities are considered unapproved drugs. FDA checks for the effectiveness and […]
January 4, 2017

Organ-On-Chip Technology!

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 […]
January 2, 2017

What Is Integrated Summary Of Safety Reports (ISSR)

ISSR is a comprehensive and detailed analysis about the safety of drugs in development. Although it is termed a summary, it includes a […]
December 29, 2016

Future Of Drug Development And Drug Delivery In The US!

Drug development refers to the stages of drug research and discovery that bring the newly discovered drug to the market with regulatory approval.
December 23, 2016

Top Skills Required For Drug Safety Positions!

Patient safety in clinical trials has become prominent in the priorities of clinical research organizations (CRO) and other sponsors. In lieu of this […]
December 15, 2016

Biopharma Preclinical Development Process

Preclinical development processes for biopharmaceutical products refer to drug discovery, drug research and experimental testing on life forms other than humans that occur […]
December 8, 2016

Benefits Of Studying Drug Safety In The United States!

Drug safety or pharmacovigilance, as it is formally termed, is the field of science that is responsible for assessing, identifying and recording the […]
December 1, 2016

Quality Risk Management For Aseptic Processing!

According to the food and drug agency (FDA), sterile drug products are manufactured by two methods. They are terminal sterilization and aseptic processing. […]