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Microdosing
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Microdosing
Microdosing, or micro-dosing, involves the administration of sub-therapeutic doses of drugs to study their effects in humans, aiming to gather preliminary data on safety, pharmacokinetics, and potential therapeutic benefits without producing significant physiological effects. This is called a "Phase 0 study" and is usually conducted before clinical Phase I to predict whether a drug is viable for the next phase of testing. Human microdosing aims to reduce the resources spent on non-viable drugs and the amount of testing done on animals.
Less commonly, the term "microdosing" can be used to refer to precise dispensing of small amounts of a drug substance (e.g., a powder API) for a drug product (e.g., a capsule) and, when the drug substance also happens to be liquid, this can potentially overlap with the term microdispensing .
The basic approach is to label a candidate drug using the radio isotope carbon-14, then administer the compound to human volunteers at levels typically about 100 times lower than the proposed therapeutic dosage (from around 1 to 100 micrograms but not above).[citation needed]
As only microdose levels of the drug are used, analytical methods are limited. Extreme sensitivity is needed. Accelerator mass spectrometry (AMS) is the most common method for microdose analysis. AMS was developed in the late 1970s from two distinct research threads with a common goal: an improvement in radiocarbon dating that would make efficient use of datable material and that would extend the routine and maximum reach of radiocarbon dating. AMS is routinely used in geochronology and archaeology, but biological applications began appearing in 1990 mainly due to the work of scientists at Lawrence Livermore National Laboratory. AMS service is now more accessible for biochemical quantitation from several private companies and non-commercial access to AMS is available at the National Institutes of Health (NIH) Research Resource at Lawrence Livermore National Laboratory, or through the development of smaller affordable spectrometers. AMS does not measure the radioactivity of carbon-14 in microdose samples. AMS, like other mass spectrometry methods, measures ionic species according to mass-to-charge ratio.
Davivid Rose (also known as jdyf333 and as Hank Exclamation Point) invented the word "microdose" in 1980 to describe a 5 microgram dose of LSD.
"If the story about 'Clearlight Brand "microdose" LSD' is true, then the origin of the term 'microdose' for very small doses of LSD precedes all other uses of the term, e.g. in pharmacology (since 1995), in agriculture (since 2005) and by Fadiman (2011)."
---German psychiatrist Torsten Passie, in his 2019 book The Science of Microdosing Psychedelics, published by Psychedelic Press. The book reproduces a page of the product information leaflet for "Clearlight brand 'microdose' LSD" that Davivid Rose wrote and distributed in early 1988.
("The name Clear Light was a promise about the mind-state the material itself produced: as a famously 'clean' form of LSD, its effects were described as limpid, even at high doses. In later decades, the first branded packaging of LSD microdoses [5 μg] was also named Clear Light."
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Microdosing
Microdosing, or micro-dosing, involves the administration of sub-therapeutic doses of drugs to study their effects in humans, aiming to gather preliminary data on safety, pharmacokinetics, and potential therapeutic benefits without producing significant physiological effects. This is called a "Phase 0 study" and is usually conducted before clinical Phase I to predict whether a drug is viable for the next phase of testing. Human microdosing aims to reduce the resources spent on non-viable drugs and the amount of testing done on animals.
Less commonly, the term "microdosing" can be used to refer to precise dispensing of small amounts of a drug substance (e.g., a powder API) for a drug product (e.g., a capsule) and, when the drug substance also happens to be liquid, this can potentially overlap with the term microdispensing .
The basic approach is to label a candidate drug using the radio isotope carbon-14, then administer the compound to human volunteers at levels typically about 100 times lower than the proposed therapeutic dosage (from around 1 to 100 micrograms but not above).[citation needed]
As only microdose levels of the drug are used, analytical methods are limited. Extreme sensitivity is needed. Accelerator mass spectrometry (AMS) is the most common method for microdose analysis. AMS was developed in the late 1970s from two distinct research threads with a common goal: an improvement in radiocarbon dating that would make efficient use of datable material and that would extend the routine and maximum reach of radiocarbon dating. AMS is routinely used in geochronology and archaeology, but biological applications began appearing in 1990 mainly due to the work of scientists at Lawrence Livermore National Laboratory. AMS service is now more accessible for biochemical quantitation from several private companies and non-commercial access to AMS is available at the National Institutes of Health (NIH) Research Resource at Lawrence Livermore National Laboratory, or through the development of smaller affordable spectrometers. AMS does not measure the radioactivity of carbon-14 in microdose samples. AMS, like other mass spectrometry methods, measures ionic species according to mass-to-charge ratio.
Davivid Rose (also known as jdyf333 and as Hank Exclamation Point) invented the word "microdose" in 1980 to describe a 5 microgram dose of LSD.
"If the story about 'Clearlight Brand "microdose" LSD' is true, then the origin of the term 'microdose' for very small doses of LSD precedes all other uses of the term, e.g. in pharmacology (since 1995), in agriculture (since 2005) and by Fadiman (2011)."
---German psychiatrist Torsten Passie, in his 2019 book The Science of Microdosing Psychedelics, published by Psychedelic Press. The book reproduces a page of the product information leaflet for "Clearlight brand 'microdose' LSD" that Davivid Rose wrote and distributed in early 1988.
("The name Clear Light was a promise about the mind-state the material itself produced: as a famously 'clean' form of LSD, its effects were described as limpid, even at high doses. In later decades, the first branded packaging of LSD microdoses [5 μg] was also named Clear Light."