On Apr 25, 3:27 am, Jeff L
gmail.com> wrote:> Pixie wrote:
>> REALLY?? Well, I guess you know JACK SHIT ABOUT HOW TO GET A
>> MEDICATION APPROVED IN THE PHARMACEUTICAL INDUSTRY, do you??
>> Traci Johnson, oh sorry, i assumed that you could actually read
>> links.
>
> I'll admit I hadn't read your link at the time I submitted this posting,
> and I retract my prior statement.
>
> Pixie wrote:
>> WELL FUCK ME, PHASE I TRIALS OF DRUGS ARE INHERENTLY WRONG??
>
> Indeed. It makes, as I've said, absolutely zero sense to test a drug
> with psychiatric properties on a person who has no psychiatric problems.
well, ACTUALLY, IT DOES if you read how clinical trials are designed,
because they are testing MORE than the psychiatric effects, Pre-
clinical studies involve in vitro (i.e., test tube or laboratory)
studies and trials on animal populations (in vivo). Phase 0 is a
recent designation for exploratory, first-in-human trials conducted in
accordance with the U.S. Food and Drug Administration’s (FDA) 2006
Guidance on Exploratory Investigational New Drug (IND) Studies.[7]
Phase 0 trials are also known as human microdosing studies and are
designed to speed up the development of promising drugs or imaging
agents by establishing very early on whether the drug or agent behaves
in human subjects as was anticipated from preclinical studies.
Phase I trials are the first stage of testing in human subjects.
Normally, a small (20-80) group of healthy volunteers will be
selected. This phase includes trials designed to assess the safety
(pharmacovigilance), tolerability, pharmacokinetics, and
pharmacodynamics of a drug.
Phase II-
Once the initial safety of the study drug has been confirmed in Phase
I trials, Phase II trials are performed on larger groups (20-300) and
are designed to assess how well the drug works, as well as to continue
Phase I safety assessments in a larger group of volunteers and
patients. When the development process for a new drug fails, this
usually occurs during Phase II trials when the drug is discovered not
to work as planned, or to have toxic effects.
Phase III studies are randomized controlled multicenter trials on
large patient groups (300–3,000 or more depending upon the disease/
medical condition studied) and are aimed at being the definitive
assessment of how effective the drug is, in comparison with current
'gold standard' treatment.
Phase IV trial is also known as Post Marketing Surveillance Trial.
Phase IV trials involve the safety surveillance (pharmacovigilance)
and ongoing technical support of a drug after it receives permission
to be sold. Phase IV studies may be required by regulatory authorities
or may be undertaken by the sponsoring company for competitive
(finding a new market for the drug) or other reasons (for example, the
drug may not have been tested for interactions with other drugs, or on
certain population groups such as pregnant women, who are unlikely to
subject themselves to trials).
> Ritalin, for example, is a stimulant. The effect it has on a person
> without ADHD is significantly different than the effect it has on a
> person with ADHD. I wasn't aware that they tested these drugs on people
> who would not have any problems that the drug would be designed to treat.
oooh, Jeff, it doesnt look like you know as much as you assumed you
did about pharmaceuticals does it?
i am very proud that you could actuallly read that, see? you learn
something new everyday, and i am sure that you would be surprised as
hell at some of the "medical practices" of some "qualified" medical
doctor. no, these things shouldnt happen but they DO, every day.
Like getting cut off medication cold turkey by doctors advice.
i am actually very proud you learned something today! :-)
