drug discovery & development 13
MHRA response time for clinical
trial applications (CTAs) submitted
is just 12.9 days (see www.mhra.
gov.uk).
It’s true that we are in the early
stages here, but both industry and
regulators are very receptive. Drug
development looks set for radical
change over the next few years.
Many expect that the combination
of rapid manufacture and early
clinical evaluation will significantly
reduce timelines, cut costs and
lead to clear decision-making.
This new paradigm is supported
Fig. 4. Drug absorption profiles in the upper small intestines (PSB), lower small intestines
by innovative technologies such
(DSB) and colon, indicating an absorption window for this drug limited to the proximal small
as Enterion for drug absorption
bowel (PSB).
studies, and ivMicrotracer for
absolute bioavailability and metabolism studies. than would have determined in the lab.
As a result, development professionals now have As a ballpark estimate, if you consider the compound
the ability to effectively direct formulation strategies – under evaluation has the potential to be a billion dollar
informed by solid data from clinical studies in man. drug, then every day of launch delay costs around
Following completion of a programme designed to US$3.3 million. Saving six months translates into sales in
assess the suitability of a candidate for MR formulation, the region of $600 million. u
a director of one leading pharmaceutical company
recently commented that the work Pharmaceutical Dr Andrew Rankin is Chief Scientific Officer, Pharmaceutical
Profiles had completed allowed them to put the idea of Profiles, Nottingham, UK. For more information, visit
MR formulation ‘to bed’ approximately six months earlier www.pharmprofiles.co.uk
Exact Graphs and Data Analysis
circle 13 or ✔ at www.scientistlive.com/elab
Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44