Download Microdose and microtracer information sheet

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Microdose/microtracer expertise at Quotient Clinical
Quotient Clinical has been a leading provider of microdose and microtracer studies since 2006. Our overall
experience of tracers covers more than 65 molecules and more than 30 client companies, resulting in over
20 publications.
Intravenous (IV) microtracer studies require the simultaneous administration of the IV-radiolabelled drug and the
oral drug formulation. The radiolabelled component is then analysed by LC-AMS, and the unlabelled component by
LC-MSMS.
Oral tracer studies can provide a useful means of generating human mass balance and metabolism data where
dosing at a clinical dose is impractical. Examples are studies with cytotoxic molecules, potent drugs, or drugs with
extremely long half-lives where drug and radioactivity exposure to the subject may be a concern.
Phase 0 microdose studies are performed when our clients have specific issues, where access to early human data
will be a key driver in candidate selection or to aid pharmaceutical development. These studies are now frequently
performed with unlabelled drug and sample analysis by LC-MSMS.
www.quotientclinical.com
www.quotientclinical.com
Quotient-Microdose-microtracer-ADME_Layout 1 18/05/2016 14:21 Page 2
The study list from the last three years is as follows:
Study
Client Type
Phase
112696
Large pharma
II
113845
Pharma
112599
113050
112387
114878
115178
115169
115578
Pharma
Large pharma
I
II
I
Study Type
Objective
Subjects
Microtracer
IVPK/abs bio
6
Microdose
Microtracer
ivMT/ADME
IVPK
IVPK/abs bio
Abs bio/met
Biotech
III
Micro ADME
Mass balance
Pharma
II
ivMT/ADME
Abs bio/met
Biotech
Biotech
Pharma
III
I
II
Microtracer
Microdose
Microtracer
IV
IVPK/abs bio
12
III
ivMT/ADME
Abs bio/met
Pharma
I
110166
Biotech
116682
Biotech
13C
IV/oral
Y
IV
12
Y
Y
II
ivMT/ADME
Abs bio/met
6
IV/inhaled
Y
II
Microtracer
IVPK/abs bio
10
IV
Y
ivMT/ADME
Abs bio/met
6
IV/oral
Y
III
III
Pharma
IV
Y
Large pharma
116252
N
IV/oral
III
117496
6
IV
12
Biotech
Large pharma
6
Y
Abs bio/met
117356
117378
IV
ivMT/ADME
Large pharma
Biotech
6
II
117150
117219
6
Y
12
Biotech
Large pharma
IV/oral
IVPK/abs bio
IVPK
116482
117364
6
Y
Y
IVPK/abs bio
117173
IV
Y
IV/oral
Microtracer
Microtracer
6
Y
IV
6
IVPK/abs bio
II
II
Oral
Y
Large pharma
Large pharma
18
C?
14
IV
116562
116253
Route
ivMT/ADME
ivMT/ADME
Abs bio/met
Abs bio/met
I
ivMT/ADME
II
Microtracer
IVPK/abs bio
ivMT/ADME
Abs bio/met
II
Microtracer
Abs bio/met
IVPK/abs bio
12
6
12
8
12
6
IV/oral
IV/oral
IV/oral
Y
Y
Y
IV
Y
IV/oral
Y
IV
Integrating formulation development, real-time manufacturing and clinical testing, our Translational
Pharmaceutics® platform plays an important role in these studies, providing rapid, fit-for-purpose formulation
development for oral and intravenous radiolabelled formulations.
Y
Get in touch to see how we can save you valuable time and reduce investment costs.
+44 (0) 115 974 9000 / 1-800-769-3518 (USA)
[email protected]
Iain Shaw, Director 14C Enabled Drug Development
[email protected]
About Quotient
Quotient Clinical offers unique services – based on Translational Pharmaceutics® – that integrate formulation development,
real-time drug product manufacturing and clinical testing, significantly reducing the time and cost of bringing a drug to
market.
For more than 20 years, Quotient Clinical has brought innovation to drug product development programs for pharmaceutical
and biotechnology customers worldwide. The company is based in purpose-built, fully integrated facilities in the UK, where
formulation development, real-time GMP manufacturing and early clinical trials are performed in the same facility. It
employs over 320 staff, offering a full range of support services, from study set-up right through to data analysis and
reporting.
www.quotientclinical.com
www.quotientclinical.com