Can you find a listing of medications or medication categories that
have the corresponding labs or medical tests neccessary to monitor
safety and efficacy?

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Request for Question Clarification by tehuti-ga on 09 Jul 2002 16:55 PDT

Hello sjt11

A new medication has to pass through a huge number of tests before it
can be marketed.  These will range from simple physicochemical tests,
use of computerised expert systems, through investigations in cell
cultures, studies in animals, studies in healthy human volunteers, and
finally clinical trials in patients.  The exact tests are not laid
down as such by the FDA.  It is up to the study leader to decide what
tests are appropriate for the type of compound that is being tested
and its intended use.  The exact design of the study, eg with respect
to species and numbers of animals used, will depend on whether the
study has to satisfy more than one regulatory authority.  Since so
much depends on precedent, sometimes more testing is done that might
actually be required, in order to avoid the risk of having the
regulator decide that further testing will be needed.

The complexity of the process can be seen in the number of guidance
documents provided by the FDA at
http://www.fda.gov/cder/guidance/index.htm

I have put this as a clarification rather than an answer, because I
think you were hoping for something more specific.

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Request for Question Clarification by tehuti-ga on 09 Jul 2002 18:05 PDT

Maybe I should add that my day job requires me to be familiar with
drug testing issues.

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Clarification of Question by sjt11-ga on 10 Jul 2002 06:38 PDT

When I asked this question, I had no intentions of knowing what the
FDA wants pre-marketing.  I'm looking for a list of what are the
recommended labs and medical tests (monitoring parameters) a patient
should have done while taking certain medications. I'm looking to
create a tool to educate nurses about what labs should be ordered when
a MD prescribes a drug.

Example: when a patient is on Dilantin (phenytoin) some common labs
the MD might order are routine phenytoin levels, complete blood cell
counts (CBC's), liver function tests (LFT's)

Just as a side note, since there has been no further response, I
thought I'd mention that Rxlist.com has excellent information (and a
sounds-like search).  If you select a medication, then go to the
Warnings/Precautions, it will normally have indications for what lab
tests will need to be done by the physician.  As an example, check out
the warning/precautions tab on Lasix/furosemide.