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Expert perspectives focused on the latest bioanalytical topic & trends

The Importance Of GMP Certification In Drug Development

Production and sale of therapeutic drugs requires tight control over the manufacturing, processing, and labeling of these products to ensure the safety of the end user. In the United States, regulations for maintaining the quality of medications such as these are under the jurisdiction of the Food and Drug Administration (FDA). They are referred to as Good Manufacturing Practice (GMP) or Current Good Manufacturing Practice (CGMP) regulations. GMP regulations mandate

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Are We Closer to Using the Word “Cures” More Often?

As we look towards the development of the next generation of drugs and therapies, it starts to beg the question of whether we are creating the next “cure” or the next “treatment.” A cure would require actively restoring the patient to full health with no disease left whereas a treatment shows an improvement in health but the underlying disease still remains. Both cures and treatments are obviously important but the

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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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Flow Cytometry in Bioanalysis: Application, Utility and Recent Advancements

Flow Cytometry in Drug Development Flow cytometry is a technique that is used to analyze multiple characteristics of single cells. These characteristics include cell size, cytoplasmic complexity of the cell, as well as expression of cell surface and intracellular proteins. This unique technology utilizes fluidics, optics, and electronic components to interrogate each cell by lasers as it flows through the sample stream. The dispersed light and emissions from excited fluorophores

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