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DEVELOPMENT
A drug may be broadly defined as any chemical
agent that affects living protoplasm.
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DISCOVERY
Develop an assay to evaluate activity of compounds on the target
- in vitro (e.g. enzyme assay)
- in vivo (animal model or pharmacodynamic assay)
Identify a lead compound
screen collection of compounds (“compound library”)
compound from published literature
screen Natural Products
structure-based design (“rational drug design”)
Mechanism-based design
Clinical
Phase II
Trials 50-500-impaired patients Information Learned
1. Effectiveness in treating disease
Treatment Group Control Group 2. Short-term side effects in health -impaired patients
3. Dose range
Compassionate Use
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Clinical Advisory
Committee Regulatory
Trials Review Team
Continued
APPROVAL
Reviews,
PROCESS comments, and
(Ex. FDA)
discussions
Submit to
Regulatory Agencies
Drug Co./Regulatory
liaison activities
New Drug
Application
(NDA)
APPROVAL
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Drug Discovery—Convergence of Disciplines
Synthetic
Combinatorial Patent Law
Chemistry
Chemistry
Modelling
Novel
Intellectual Property
Molecule Physiology
Information Design Structural Biochemistry
Technology
Activity
Physiology
Safety Pharmaco- Physiology
Metabolism
dynamics Pharmacology
Safety
Assessment Immunology
In Vivo activity Pharmacokinetic
Properties DMPK
Pharmacology Behavior
Pathology Enzymology
Physiology Physical Physiology
Chemistry
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The
drug
develop
ment
process
from
discove
ry
throug
h
preclini
cal and
clinical ,
FDA
review
of the
new
drug
investig
ation
and
post
marketi
ng
surveill
ance
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