What are receptor occupancy assays?

Flow Cytometry utilizes fluorescently labeled antibodies to detect specific biomarkers on the surface and within cells, and over the past few years, there has been a surge in reagents available for flow cytometry applications. Most of these have been developed using monoclonal antibodies raised in mice and conjugated to a range of fluorophores. However, there are still instances where suitable monoclonal antibody reagents/conjugates are not commercially available, and small-scale conjugations are not practical. In these instances, so-called indirect staining may be employed, where the binding of an unconjugated primary antibody is detected using a secondary anti-IgG antibody conjugate.

Tissue and Non-Liquid Matrices (such as cell lines, red blood cells, PBMCs, bone marrow aspirates, and suspension cells) are valuable matrices[] to test for biomarkers (PD) and drug levels (PK). Testing of tissues and…

Pharmacodynamics (PD) is defined as the study of the biochemical and physiological effects of drugs and the mechanisms of their actions. Where pharmacokinetics looks at how the organism processes the drug, pharmacodynamics studies how…

Drug discovery is an essential part of the drug development process. Testing in drug discovery is the mechanism to provide drug candidates that are selected for regulated animal studies and hopefully moving into clinical trials.

As the Bioanalytical support for drug development continues to grow, more and more scientists are requiring more complex assays. Two examples are cell based assays and what we refer to as live cell assays.

The 505(b)(2) drug development path, in contrast to traditional development of a new, never been approved drug (described under 505(b)(1) of the Federal Food, Drug, and Cosmetic Act) or ANDA (described under Section 505(j) of the Act) for a generic drug that is no longer under patent…

Finding a laboratory to successfully transfer and GLP validate your PK method can be a challenge. Yes sure the big labs can do it, but if you are not a preferred provider you may find yourself working with the B team that doesn’t move as fast as you need, and…