The U.K. Medicines and Healthcare Products Regulator Agency dropped a guidance for digital mental health technologies that clarifies several key points, such as when the DMHT qualifies as software as ...

The small world was found during a search for the hypothetical Planet Nine, and astronomers say the next time it will reach its closest point to the sun is in the year 26186.

The Fa equation incorporates the Biopharmaceutics Classification System (BCS), categorizing drugs based on their dose and permeation numbers.

The project has now been funded for the Biopharmaceutics Classification System (BCS) drug classification using LLMs, as the transformative potential of artificial intelligence (AI), particularly LLMs, ...

Leveraging quality by design principles presents a pathway to craft bioequivalent products efficiently, particularly through the expansion of Biopharmaceutics Classification System (BCS) waivers and ...

T. Loftsson, “Cyclodextrins and the Biopharmaceutics Classification System of Drugs,” Journal of Inclusion Phenomenon, Vol. 44, No. 1-4, 2002, pp. 63-67.

Simcyp Biopharmaceutics software also helps sponsors develop the evidence needed to attain biowaivers which are used in lieu of conducting clinical studies.

What is the Biopharmaceutics Classification System (BCS)? The BCS is a regulatory tool that is used to justify clinical biowaivers for certain types of compounds (BCS Class I and III) based on ...

The guidance document gives recommendations to support biopharmaceutics classification of drug substances and the Biopharmaceutics Classification System-based waiver of the in-vivo bioequivalence ...

The US Food and Drug Administration has published the guidance for industry entitled “ M9 Biopharmaceutics Classification System-Based Biowaivers,” a draft of which was issued in October 2018. The ...