DMPK OverviewQPS provides immediate access to a dedicated team of experienced scientists to help select, design

and conduct the appropriate ADME studies for your specific compound and therapeutic target

D M P K O V E R V I E W

Q W B A

P R O T E I N B I N D I N G

C Y P I N D U C T I O N

C Y P I N H I B I T I O N

X E N O G R A F T M O D E L S

A D M E S U M M A R Y R E P O R T

R A D I O L A B E L M A S S B A L A N C E

C L I N I C A L D R U G D E V E L O P M E N T

B I O A N A L Y T I C A L

P H A R M A C E U T I C A L

P R E C L I N I C A L

B I O T E C H N O L O G Y

T R A N S L A T I O N A L M E D I C I N E

G L O B A L C R O

D I S C O V E R Y

Q U A L I T Y S E R V I C E S

R N A I T H E R A P E U T I C S

T K M O D E L I N G

H U M A N M A S S B A L A N C E

M E T A B O L I T E P R O F I L I N G

M E T A B O L I T E I D E N T I F I C A T I O N

T I S S U E D I S T R I B U T I O N

A D M E

F E T U S

Introduction to QPS’ DMPK Services:For many, especially virtual, small and mid-size, pharmaceutical

firms, outsourcing ADME studies to an experienced CRO such as

QPS is a practical alternative to building or expanding an internal

DMPK department. Outsourcing to QPS has many compelling

advantages that are primarily associated with expanded expertise

and improved cost effectiveness.

The primary reasons why you should choose QPS as your preferred CRO for

all your ADME sourcing needs.

Direct Peer-to-Peer InteractionsYou get immediate access to a team of senior scientists that have 15+ years of pharmaceutical and biotech drug discovery and development experience. We will work with you to conduct the appropriate ADME studies across a broad range of compound structures and therapeutic targets.

Furthermore, the same group of scientists also has additional 10+ years of CRO experience. Given this combination, QPS has breadth and depth from the perspective of the client as well as the service provider. You will benefit from direct peer-to-peer interactions and management of scientific, technical, and operational interactions by a seasoned scientist that has previously led discovery or development teams.

Fast TurnaroundHistorical data clearly demonstrate that the direction taken by drug discovery and development is substantially influenced by ADME results. Our scientific experience, integrated services, and application of state-of-the-art bioanalytical equipment provides fast turnaround that will help you quickly arrive at go/no-go decisions thereby reducing your total developmental costs.

Customer FocusMost of our senior level technical managers used to be involved with either contracting or monitoring out-sourced studies, so we understand exactly what is needed to be in a contracting partnership. We run your discovery and development programs with the ultimate care and commitment that you would expect from QPS.

From In Vitro DDI and Metabolism studies to Whole-Body Autoradiography of a pregnant rat to Heart Autoradiography to Microautoradiography

C L I N I C A L D R U G D E V E L O P M E N T

B I O A N A L Y T I C A L

P H A R M A C E U T I C A L

P R E C L I N I C A L

B I O T E C H N O L O G Y

T R A N S L A T I O N A L M E D I C I N E

G L O B A L C R O

D I S C O V E R Y

Q U A L I T Y S E R V I C E S

Cost EffectiveOur DMPK department focuses on core services within our specific areas of expertise, and we integrate the various study components to gain additional efficiencies. This translates to improved overall project and time management which in turn translates to high quality, cost effectiveness and effective capacity utilization. QPS Delaware and Taiwan are both AAALAC accredited facilities and are both part of governmental GLP inspection programs. All regulatory-filing studies are performed in compliance according to the latest FDA or ICH or OECD guidance documents.

QPS offers a full range of DMPK services including:

Pharmacokinetics Formulation All Routes of Administration Bioanalysis PK/TK Modeling PK/PD Modeling Xenograft Models Protein Binding

Radiolabel Tissue Distribution (QWBA & Micro-Autoradiography)

Mass Balance/Excretion/BDC Metabolite Profiling, ID & Radio-quantitation

Consulting Program Development Consulting Mechanistic Studies ADME Summary for Regulatory Submission

Drug Metabolism Metabolic Stability Species Comparison Reaction Phenotyping Metabolite Profiling and Structural Elucidation Models to Evaluate Low CLint

DDI Enzyme Induction CYP450 Inhibition Concomitant Medication(s) DDI

Drug Transporters

Efflux transporters (P-gp and BCRP) SLC Transporters (Hepatic and Renal) Hepatic Uptake (Passive vs. Active)

Research Tools Custom Liver Co-culture Assays Custom Microsome Preparations Human Cryo NeuronsTM

Human Neural Stem Cells Liver Biomatrix Custom Media Production Assay Specific Hepatic Media Stem Cell Lineage Media

Cost EffectiveOur DMPK department focuses on core services within our speci� c areas of expertise, and we integrate the various study components to gain additional ef� ciencies. This translates to improved overall project and time management which in turn translates to high quality, cost effectiveness and effective capacity utilization. QPS Delaware and Taiwan are both AAALAC accredited facilities and are both part of governmental GLP inspection programs. All regulatory-� ling studies are performed in compliance according to the latest FDA or ICH or OECD guidance documents.

QPS offers a full range of DMPK services including:

Pharmacokinetics Formulation All Routes of Administration (including but not

limited to: IV, PO, intraportal, intraduodenal and intracranial)

Bioanalysis PK/TK Modeling PK/PD Modeling Xenograft Models Protein Binding

DDI / Metabolism CYP Inhibition/Induction Species Comparison Reaction Phenotyping Metabolite Pro� ling and Structural Elucidation

Radiolabel Tissue Distribution (QWBA & Micro-Autoradiography)

Mass Balance/Excretion/BDC Metabolite Pro� ling, ID & Radio-quantitation

Consulting Program Development Consulting Mechanistic Studies ADME Summary for Regulatory Submission

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QPS-DMPK-BROC.indd 6 02-03-12 13:14

Call to arrange for a tour at one of QPS’ worldwide DMPK locations today

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1 QPS|Delaware 2 QPS|Hepatic Biosciences 2 QPS|Taiwan

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Time is of the essence

in drug development,

so contact a member

of the QPS Business

Development Team today

and find out what QPS

can do for you.

HQ BD Office Lily Rosa (USA)

+1 512 350 2827 info@qps.com

QPS Hepatic Biosciences6 Davis Drive, RTP, NC 27709, USA

+1 877 HEPABIO (+1 877 437 2246)

Company Values: Integrity - We make and keep promises and build trust through honesty, proactive communication and reliability - Quality - We bring the highest level of technical expertise and judgement to our work - Customer Focus - We tap our global resources to provide service that is fast, flexible and integrated - Commitment - We work hard to solve problems and deliver results - People - We treat people with dignity, respect and fairness, and embrace our differences - Culture - We are friendly and fun. We provide opportunities to grow, we value loyalty and teamwork, and we recognize and reward performance.