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Monday, 13 September 2021
Tuesday, 31 August 2021
Monday, 23 August 2021
Monday, 16 August 2021
learning journal
something new i learnt last week: how to not be a clown.
learning that i struggled with: my video i made in manaiakalani.
Wednesday, 11 August 2021
Wednesday, 28 July 2021
Monday, 14 June 2021
Wednesday, 2 June 2021
Friday, 28 May 2021
Wednesday, 12 May 2021
Wednesday, 5 May 2021
favorite colours in LH7
today we in cyber smat we did math
BRINGING A DRUG TO MARKET
WHAT IS
A CLINICAL
TRIAL?
New tests and treatments aren’t offered to the public as soon as they’re made, they need to be studied. A clinical trial is a type of research that studies a test or treatment given to people. When tests and treatments are found to be safe and helpful, they may become tomorrow’s standard of care.
CLINICAL TRIALS
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DISCOVERY &
PRE-CLINICAL TEST
PRE-CLINICAL TEST
Testing done by scientific researcher on drug in non-human subjects, to gather efficacy, toxicity and pharmacokinetic information.
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CLINICAL TRIAL PHASES,
PURPOSES AND TIMELINE
Scientific Researcher
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Pharmacokinetics; particularly, oral bioavailability and half-life of the drug.
PARTICIPANTS
Clinical Researcher
N/A Success Rate
PRE PHASE 1
PHASE 1
Testing of the drug on about 50 healthy volunteers for safety; involves testing
multiple doses. This determines whether the drug is safe to check for efficacy.
Clinical Researcher
70% Success Rate
DOSE RANGING TEST
PHASE 2
Testing of the drug on 100 - 300 patients to assess efficacy and side effects. This test determines whether a drug can have any efficacy; at this point, the drug is not presumed to have any therapeutic effect whatsoever.
PARTICIPANTS
DOSAGE
Clinical Researcher
33% Success Rate
EFFICACY TEST
(various)
GOALS
Side effects
Efficacy
PHASE 0
PHASE 3
Testing of drug on 300 - 3000 patients to assess efficacy, effectiveness and safety. This test determines a drug's therapeutic effect; at this point, the drug is presumed to have some effect.
PARTICIPANTS
DOSAGE
Clinical Researcher, Personal Physician
25% - 30% Success Rate
EFFICACY TEST
(fixed)
GOALS
Over longer periods
Efficacy
Against other existing treatments
PHASE 4
Watching drug use in public over a longer period of time, in a different group of people and/or in combination with other treatments.
Personal Physician
N/A Success Rate
POST MARKETING SURVEILLANCE
PARTICIPANTS
DOSAGE
GOALS
Treatment deemed save / effective
Long term effects
Source: https://en.wikipedia.org/wiki/Phases_of_clinical_research
Wednesday, 24 March 2021
the refinery is always right
Wednesday, 10 March 2021
all about me
hi my name is lochie and I go to gisent school and I like playing games and riding dirt bikes and talking to my friends.