Biology Reference
In-Depth Information
(continued)
But the “1-to-many PSDD” would support the drug-discovery approach
wherein any chemical agents, regardless of whether or not approved by
FDA, can qualify as the components of a new, “higher-order” drug.
It would be necessary therefore to distinguish two classes of drugs - (1) the
traditional, single-agent based drugs to be referred to as the “first-order” or
“linear” drugs, and (2) the “nth-order drugs” composed of n chemical
components where n can be 2, 3, 4, etc., which may be referred to as the
“nonlinear” drugs. I firmly believe that there is no scientific basis for FDA
restricting drug-discovery activities to “first-order drugs” and that FDA may
have to relax its regulations to accommodate high-order drugs in order to
improve the efficiency (and competitiveness) of developing new drugs in the
coming decades.
As I indicated after your talk, I think the traditional chemistry-based drug
discovery approach may be too
precise
for the complex nature of living
processes, just as mathematics are often
too precise
for physics, prompting
Einstein to make the following remark:
As far as the laws of mathematics refer to reality, they are not certain; and as far as
they are certain, they do not refer to reality.
(1)
Analogously, it may be stated that
As far as the laws of chemistry refer to pharmacology, they are not certain; and as far
as they are certain, they do not refer to pharmacology.
(2)
For example, Statement 2 would predict that, although careful molecular
designing can decrease the K
i
values of a serine protease inhibitor by a factor
of 10
4
or 10
5
, this would not necessarily translate into a similar increase in the
associated therapeutic index for anticoagulant activities.
In fact, Statement 2 suggests that serine protease inhibitors with high K
i
values (that would routinely have been discarded as ineffective agents in the
early stages of drug discovery process) can serve as better components of
high-order drugs for anticoagulant activities than their counterparts with low
K
i
values.
If Statement 2 proves useful in drug discovery and other pharmacological
researches, we may be justified to refer to it as the “Pharmacological Uncer-
tainty Principle (PUP)” in analogy to the Heisenberg Uncertainty Principle
(HUP) in physics. It was suggested elsewhere that PUP and HUP may be
instances of a more general uncertainty principle operative in the Universe
referred to as the Universal Uncertainty Principle (UUP) (Molecular Theory
of the Living Cell, cited above, pp. 151-152).
