New Drugs: Development and Approval Pathways

1. In the name of ALLAH, the most Gracious and the most Merciful
New Drugs: Development & Approval Pathway
PBRS 2015
Obaid Ali &
Roohi B. Obaid
April 19, 2015 :Group A & April
25, 2015 for Group B

2. New Drugs
Development & Approval Pathway
Group A:19 April & Group B: 25 April 2015
Day 2
PBRS 2015
Obaid Ali, Roohi B. Obaid

3. The views expressed in this
presentation are not necessarily
of the DRAP
It is an informal communication
that represents the best current
judgment and does not constitute
an advisory opinion or binding or
otherwise obligate or commit the
DRAP, to the views expressed.
This presentation is designed by
the speaker after consulting
international reference
documents for e.g. US-FDA
New Drugs
Development & Approval Pathway

4. Opening Message
All things are poison and nothing is without
poison, only the dose makes a thing not poison
All models are wrong but some are useful

5. Presentation Focus

7. Drug Approval Process Snapshot

8. RA Promise

12. An IND is filed prior to initiation of clinical trials
in humans if it is to evaluate a

27. Work on Simple Ideas

28. Sound and look alike……

29. Rationale for proprietary name analysis
Learn
how will
be done

30. Intelence (Etravirine) Tablets
Letters in Name
INTELENCE
Scripted may appear as Spoken may be interpreted as
I e. L any vowel
n v, r, s, m
t f, r, x d
e i, l any vowel
l b, e, h
c a, r S
Look a like and sound alike letters

31. Intelence (Etravirine) Tablets
In-patient
medication order
Verbal
prescription
Out-patient
medication order
Untelince Atalence Intelence
Intelence Intalents Intelence
Intelince Intellance Intelence
Intelence Intelance Intelence
Untelence Intela Intelence
Intelince Intellits Intelence
Intelence Intelants Intelence
Untelence Etalence Intelence
Intelence Intellence So on…..
decision will be based on risk
assessment related to dose,
name, sound etc.
Talents
Talon