Regulatory-Science on TouchingFish.top

The Emperor of All Maladies：the Warnings Against Drug Misuse

Sat, 04 Nov 2023 00:00:00 +0000

Re-reading "The Emperor of All Maladies."

The book chronicles the history of cancer treatment — the tragic yet heroic scientific breakthroughs, the price paid for venturing into uncharted territory. The descriptions of toxic reactions caused by the misuse of VAMP combination therapy (vinca alkaloids, methotrexate, mercaptopurine, and others) are particularly unsettling.

Drugs are a symbol of progress, yet their misuse exposes how poorly we grasp the complexity of disease and treatment. These words still sting today.

Regulating Medical Devices and Special Foods

Wed, 13 Sep 2023 00:00:00 +0000

I stared at the bottle of multivitamins on my desk.

The name was bold and assertive. The label was covered in chemical formulas I couldn't parse, and a small line of text: "Dietary Supplement." Not a health food. Not a drug. Just a "dietary supplement." Four words, light as air. But you know that for it to sit here, on this desk, a vast and intricate regulatory machine had to turn behind the scenes.

Drug Regulation and the GXP Framework

Sun, 03 Sep 2023 00:00:00 +0000

For the sake of discussion, let's say that the Black Organization is a multinational criminal syndicate.

Code name: APTX4869. It supposedly "causes death in those who take it." It also, on rare occasions, "reverses aging" in traitors to the organization — I am not an expert on the technical details, so I will leave those aside.

How far is a drug like this from actually circulating on the market?

The journey from laboratory to victim involves more than pharmacology. It must pass through a globally recognized set of technical standards. The name for this framework is GXP.