A new draft guidance from the US Food and Drug Administration (FDA) gives industry direction in how to assess drug-drug interactions for therapeutic proteins. The guidance, issued jointly by the ...

The International Council for Harmonisation (ICH) has adopted its M12 guidance, which promotes a harmonized approach in conducting and interpreting enzyme- or transporter-mediated in vitro and ...

Inside every human cell, proteins are constantly being tagged with small chemical modifications after they're produced. Known as post-translational modifications, or PTMs, these can change how a ...

Fortrea collaborates with Emery Pharma for rapid rifampin impurity testing in drug-drug interaction studies, enhancing participant safety and data quality. Fortrea, a global contract research ...

A statistical approach being used to support a new class of Alzheimer's drugs may lead to overstated claims about how the drugs work, according to a new study led by researchers at the Brown ...

A label begins with highlights, a succinct, half-page summary of the information that health care practitioners most commonly refer to and view as most important (Figure 2). [4] This section provides ...