Since 1987, you have placed your confidence in us.
Our responsibility, to which my staff and I commit, is to
consistently provide you with relevant solutions to insure
reliability, security, and timeliness.
This will be achieved with a particular emphasis on
continual investments in innovative and state-of-the-art
technologies which combine quality and timeline
optimization to benefit you.
Exceeding our clients’ expectations is our priority.
Patrick Duchêne
Chief Executive Officer
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Eurofins | ADME BIOANALYSES
75, chemin de Sommières
F - 30310 Vergèze
Tel | +33 (0)4 66 73 17 73
Fax | + 33 (0)4 66 73 17 74
www.eurofinsadmebioanalyses.com
FRANCE
Eurofins | ADME BIOANALYSES
Montpellier
A9
EXIT N°26
Vergèze
A9
Gallargues
DIRECTION
Calvisson D1
13
N1
GPS
Latitude 43.7446416
Longitude 4.2078112
Montpellier
Saintes Maries
de la mer
Nîmes
Welcome
Your partner in DMPK and in Agrosciences
Growing complexity, longer timelines, quality and confidentiality issues, high
personnel turnover, continuous searching for expertise along with low costs:
these are some of the most daunting pre-clinical and clinical research
challenges you face today when outsourcing your priority studies.
Eurofins | ADME BIOANALYSES is a GLP compliant CRO founded in 1987. In
recognition of the challenges you face, we offer you our expertise in the fields
of pharmacokinetics, metabolism, bioanalysis and residue analysis.
We are part of the EUROFINS SCIENTIFIC group.
We have been successfully inspected by GLP
Authorities:
• AFSSAPS, every two years since 1989,
• FDA, in July 2009
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We are accredited « Crédit Impôt Recherche »
(CIR) by the French Ministry of Education and
Research.
Your at Eurofins | ADME BIOANALYSES
contacts
Céline Bonati
CelineBonati@eurofins.com
Julie Piccirillo
JuliePiccirillo@eurofins.com
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Candidate
SELECTING
your drug candidate
Multiple phases of preclinical drug development
are critical to assess the safety and viability of new
chemical entities (NCE) as potential drug
candidates.
We offer a comprehensive panel of related
services that when combined with our expertise
and flexibility allow us to support your drug
development program and maximize your chance
of success. We do so by providing you the data
needed to expedite your decision process.
Do you want to
bring value to
your NCEs and
optimize your investment?
We have developed two in-vivo bioavailability tests:
• an in-vivo screening test to quickly evaluate your
NCEs’ bioavailability allowing you to select the best leads
and cut your drug development time and cost.
• an in-vivo blood brain barrier permeability test to evaluate
the ability of CNS candidates to reach the brain.
We optimize your investment bringing value to your
molecules with optimal timelines and prices.
Do you want first
to get exploratory
pharmacokinetic data prior
to start regulatory development?
Do you want
to know
the maximum
oral bioavailability?
Drug Metabolism Pharmacokinetic (DMPK) is fundamental in
drug development and will directly affect your drug’s cost of
development.
We conduct in vivo Pk screening tests to quickly compare
the Pk of your drug candidate between species.
This allows for more precise planning of your drug
development budget.
First Pass Effect
We can examine the first pass effect which allows you to
determine the maximum oral absorption achievable in each
species for your drug candidate.
IN VIVO
BIOAVAILABILITY SCREENING
The process of discovering new drugs and getting regulatory approval is becoming ever more
costly. All aspects of the drug discovery and development process should be examined for
potential cost savings. Low bioavailability of drugs will lead to increase significantly the budget
of development and will reduce the chance of success. Metabolism and first pass effect will
have to be studied early to understand the origin of this low bioavailability. In drug
development research, more than 50% of molecules fail because of lack of bioavailability.
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DMPK
Bioanalyses
Do you want
to have
more information?
• Metabolic pathway
• Metabolic profiling
• Pre-clinical studies
• Clinical studies
Do you want
to know
microsomal stability
of your molecule?
Do you want
to evaluate
the Absorption, Distribution,
Metabolism, and Excretion
of your molecule in vivo?
We perform the following in-vitro screening assays:
• Interspecies comparisons
• Cytochrome P450 enzyme inhibition
• Cytochrome P450 reaction phenotyping
• Stability in plasma and buffer
• Metabolite profiling
• Metabolite assessment and identification
Before the first administration in human, we highly
recommend the in-vivo disposition of your drug candidate be
determined.
We can conduct the following ADME studies:
• Bioavailability
• Biliary excretion
• Mass balance
• Tissue distribution
• Metabolite profiling
Once you have selected your drug candidate, DMPK
services in both the preclinical and clinical areas will be
required.
Do you need
support in DMPK
and Bioanalysis
for pre clinical and
clinical development?
Do not hesitate to ask for our expertise in:
• Development and validation of bioanalytical methods
according to International Regulatory Guidelines
• Bioanalytical assays using various equipment platforms
and methodology, including DBS (Dry blood Spot)
• Study design: number of subjects, sampling times
• PK modeling: non-compartmental and compartmental
analysis
• PK simulation
• Statistical analysis of PK parameters
• Interpretation of studies and report generation
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Why is DMPK
fundamental?
After entering the body, a drug is absorbed, distributed in the tissues, metabolised
and then excreted.
Appropriate pre-clinical studies and clinical studies are required to assess the
efficacy and safety of your molecule.
Bioequivalence, drug interaction and pediatric studies may also be required.
PK parameters are calculated from concentration time profile. Concentrations are
measured using a validated analytical method according to International Guidelines.
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Observed pharmacokinetic behaviour is a function of:
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• The physicochemical properties of drug
• The dosage form
• The route of administration
• Physiology/anatomy of the body
Poor pharmacokinetic property of a drug may limit its clinical application
Factors influencing the pharmacokinetics of a drug include genetics, size, age, disease,
other drugs, environmental factors
Components of pharmacokinetics data (primary e.g. concentration, or derived e.g.
cumulative amount excreted) and models.
The pre-clinical data help to identify promising drugs and to suggest useful doses for
testing in humans. Phase I , Phase II and Phase III of human assessment generally
correspond to the first administration to humans, early evaluation in selected
patients and the larger trials, respectively. PK data gathered during all phases of
drug development help to efficiently define safe and effective dosage regimens for
optimal individual use.
PK parameters calculation
We use KINETICA (Version 4.3 - Thermo Electron Corporation - Philadelphia - USA).
Main plasma PK parameters:
Cmax: Highest drug concentration observed in plasma following administration of an extravascular dose, mg/L or µM.
Tmax: Time at which the highest drug concentration occurs following administration of an extravascular dose, min or hr.
AUC: Area under the plasma drug concentration-time curve, mg-hr/L or µM-hr.
CL: Total clearance of drug from plasma, L/hr.
Vd: Volume of distribution (apparent) based on drug concentration in plasma, L.
Kel: Elimination rate constant, hr-1.
T1/2: Half-life, hr.
MRT: Mean time a molecule resides in body, hr.
F: Bioavailability of drug, no units.
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DERMAL
studies
Skin penetration is a route by which drugs can enter the body through the skin. The stratum corneum is the first barrier to
protect the organism from the environment. After this first layer the drug could reach the plasma after having passed the
derma and epidermis. Absorption of substances through the skin depends on a number of factors, the most important of
which are concentration, duration of contact and physical condition of the skin. Penetration through the skin can be evaluating
by using in vitro models based on Franz-type cells.
Washing
Donner compartment
Upper silastic
Dermatomed skin
Lower silastic
Excess
Flange skin
Flange skin
Epidermis /
Dermis of application suface
Stratum corneum
Epidermis / Dermis
Receptor compartment
Receptor fluid
Water Bath
Receptor fluid
Balance 100% +/-
Do you want
to evaluate your
topical formulations
or compounds?
We conduct a panel of studies to measure the percutaneous
absorption and can advise you on the design of protocols
appropriate to the objectives of your drug development.
A dedicated highly-trained team is available to conduct
dermal studies using Franz cells.
Studies can be conducted utilizing:
• fresh (only for metabolism studies in order to conserve
enzymatic properties) or frozen skin.
• all species available.
• either radiolabelled or nonradiolabelled compound.
Do you need
to compare
different formulations?
Do you need
to conduct
regulatory studies?
We can develop a screening test to compare different
compounds or different formulations of the same
compound that helps you select the one which meets your
objectives.
We have significant experienced with in vivo models used to
measure the penetration of drug formulations through the
skin in accordance to regulatory requirements (OECD 428
guidance).
We will meet Regulatory Authorities’ expectations when
conducting your studies.
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Are traceability
and report-delivery
your priorities?
We have already taken it into consideration and have made
significant investments to insure your needs are met:
Watson® Bioanalytical LIMS (Laboratory Information
Management Systems), a fully validated software package
dedicated to:
• tracking of samples
• operational efficiency -expediting laboratory results
• full traceability of the data
• regulatory compliance with GLPs
• automated report generation eliminating possible
transcription errors -delivery of the QA’ed draft report 2
weeks after the final laboratory analysis
How can we
build trust?
Because your trust is our goal, we set up Key Performance
Indicators (KPI) to monitor our commitments to you
Monthly, the following KPI are compiled and reviewed:
• Quotations within 48 h
• Meeting the timelines indicated in the study plan
• Quality assurance audits within 5 days of data
transmission Reports delivered within 15 days of the end
all laboratory analyses
Should you observe any variance on the KPIs we will
evaluate the reasons and discuss with you improvements
to our processes.
You are welcome to follow our monthly KPI results
We can also set up new KPIs dedicated to you or
periodically provide you the results you request.
Please, it’s as simple as asking our Customer Relationship
How can we
adapt our behaviour?
We have defined four different stages in the relationship we
hope to establish with you. By dealing honestly and fairly
with you and your needs we can adapt to insure you receive
the level of service you expect.
Because your expectations and needs are unique…we will
adapt our services to your needs:
Transactional
Preferred supplier
Partnership
Strategic alliance
• Responsive to requests
• Established core team
• Build corporative mechanisms
• Assigns dedicated relationship
• Makes directed investments
• Build strong collaborative mechanisms
• Share common goals/objectives
• Engage in joint stategic planning
• Relationship based structure
• Makes open-ended agreements
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