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Expert perspectives focused on the latest bioanalytical topic & trends

What Parameters Are Acquired from a PK Study?

The term “Pharmacokinetics” is derived from “pharmakon” and “kinetikos” in ancient Greek, meaning “drug” and “position in motion,” respectively. It is one of the principal assessments in the drug development process that describes what the body does to an administered drug substance and is essential data for defining safe and effective levels of drug to be administered. Currently, in drug development, there is a large variety of drug moieties with

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HUD style body scan chart graphic

The Difference Between Pharmacokinetics and Pharmacodynamics

In the United States, the safety and efficacy of prescription and over-the-counter drugs are a top priority for our government, medical professionals, and pharmaceutical companies. The Food and Drug Administration (FDA) is responsible for protecting public health by ensuring that any and all available medications are safe for human consumption, especially with regard to approving new medications or deciding whether or not a drug should be taken off the market.

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Mass Biologic Patent Expiration Creates a Race for Biosimilar Innovation

According to research from the Biosimilars Council, $81 billion worth of brand name biologics will lose their patents by 2020. As a result, we are seeing a significant increase in the development of lower cost biosimilar alternatives, as well as more applications for FDA approval of biosimilars for expiring biologic drugs. In fact, this market is expected to grow more than 25-fold over the next five years. But because the

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