How do I find an integrated solution for first-in-human and clinical pharmacology programs?
Quotient is your answer.
Clinical Pharmacology
When you are looking for a partner who is dedicated to Phase I trials and early clinical development, rely on Quotient Sciences for the experience and expertise to seamlessly deliver your studies with the highest quality service and speed. We accelerate your molecule from first-in-human to proof-of-concept, helping you make critical decisions earlier and faster. Whatever Phase I clinical pharmacology study you require, you can expect a fully integrated program from study design and startup to data reporting.
-
Proven track record spanning 30 years
-
>1,300 Phase I studies completed
-
Experts in first-in-human (FIH) and drug-drug-interaction (DDI) studies
-
Industry leading Phase I medical directors -
Ability to rapidly recruit large cohorts of volunteers
-
Fully integrated programs led by experienced project managers
Dedicated to your Phase I study
- Purpose-built Phase I units in U.S. and U.K.
- 245 beds globally
- Experienced team of 16 physicians and principal investigators
- Database of >25,000 healthy volunteers
- MHRA- and FDA-inspected facilities
- Industry-leading U.S. IRB and U.K. CTA approval timelines
Benefit from dedicated study resources
Quotient has the experience and expertise to seamlessly deliver your studies with the highest quality service and speed. If you need a fully integrated solution including data management, data analysis, statistics and medical writing, Quotient is your answer.
- Clinical pharmacology expertise including FIH (SAD/MAD), DDI, food effect and ADME experience
- Experienced project managers guiding your study to successful on-time delivery, within budget and to the highest quality
- On-site pharmacy compounding and integrated real-time adaptive GMP manufacturing
- Formulation development for all dosage forms including oral solutions and suspensions, capsules and tablets, sterile preparations (IV and SC), inhaled and nasal devices, topical creams and gels
- Early phase data sciences group providing full service data management, statistics and medical writing
- Regulatory support to ensure a seamless FDA or MHRA submission and approval process for clinical trial applications
Experience and study types
- FIH (SAD/MAD)
- DDI
- Food effect
- Thorough QT (TQT) / cardiac safety
- Bioavailability, dose proportionality and absolute bioavailability
- Bioequivalence
- Biosimilars
- 14C ADME / mass balance
- Proof-of-concept
- Pharmacodynamics / biomarkers
- Japanese bridging
Special populations
- Healthy participants
- Ages 65 and older
- Post-menopausal
- Male and female infertility
- Hypertensive
- Type II diabetics
- Asthma and allergic rhinitis
- Obese
- Healthy smokers
- Gastrointestinal diseases
- Japanese
Partner with us to develop your integrated early drug development program
Ready to accelerate your molecule from FIH to proof of concept?
Quotient is your answer.
-
Human ADME
How can I simplify the delivery of my human ADME study? Quotient is your answer.
Learn more -
Regulatory affairs
How do I ensure high-quality regulatory submissions? Quotient is your answer.
Learn more -
Data Sciences
How do I access expert data services for my clinical pharmacology studies? Quotient is your answer.
Learn more -
Modeling and Simulation
How do I enhance my clinical development program using modeling and simulation? Quotient is your answer.
Learn more
Resources
Learn more about clinical pharmacology
-
Fact Sheet
Clinical Pharmacology
When you are looking for a partner who is dedicated to Phase I trials and early development, rely on Quotient Sciences. We accelerate your molecule from first-in-human to proof-of-concept, helping you make critical decisions earlier.
-
Scientific Posters
An Open-label, Two-period Study Designed to Evaluate and Compare the Mass Balance Recovery and Metabolite Profile of 14C-Deutetrabenazine and 14C-Tetrabenazine in Healthy Male Subjects
Deutetrabenazine (Austedo, Teva) is approved for the treatment of chorea associated with Huntington’s disease (HD) and tardive dyskinesia (TD). Deutetrabenazine is the first deuterated product approved by the FDA and only the second product approved in HD and TD. Deutetrabenazine is a novel VMAT2 inhibitor that is structurally related to tetrabenazine, with two trideuteromethoxy groups at the 9- and 10-positions in tetrabenazine
-
Scientific Posters
Development and optimization of MR formulations in the absence of predictive laboratory or preclinical models
The integration of formulation design space, real-time GMP manufacturing, and an iterative sequential pharmacokinetic (PK) study in healthy volunteers was successfully applied to develop an HPMC matrix tablet that achieved the desired PK characteristics for SLx-2101.The key formulation variables influencing performance were the range of dose and release rate, hence a two-dimensional (2D) design space was mapped by manufacturing and characterizing four “regulatory batches” bracketing the corners of the compositional ranges.
-
Scientific Posters
Application Of Non Standard Approaches To Investigations Of Human Mass Balance And Metabolite Characterisation
Conventional human metabolism studies are well understood study designs which help drug companies generate data to support drug development and registration. Variations from conventional study designs can be required as a result of the specific characteristics of individual drugs or the need for particular data to support drug registration. This poster describes scenarios where alternative study designs and approaches have been required.