Kinesis: CRO in Drug Development and pharmacokinetic

CRO SERVICES IN CLINICAL DRUG DEVELOPMENT

 
Preclinical CRO services
Clinical CRO services
Regulatory CRO services
Population PK/PD modeling
Ghostwriting
Insourcing
 
  o preclinical consultancy.htm
o Study design and protocol writing
o Pharmacokinetic analysis and reporting
o Project management and study monitoring		 o Clinical consultation
o Study design and protocol writing
o Biometrics and report writing
o Project coordination		 o Regulatory affairs consultation
o Regulatory documentation
o Expert reports
o Actualisatie oude dossiers 		Population PK/PD modeling Ghostwriting Insourcing  
               

1. CONSULTATION ON CLINICAL DRUG DEVELOPMENT PLAN

Kinesis also consults on the clinical part of the drug development plan, especially phase I and phase IIa, with emphasis on pharmacokinetics. On request it characterizes the studies that need to be done for a registration of a drug product, including all regulatory aspects (see Regulatory CRO services). For many small molecules this starts with first-dose-in-man studies in healthy subjects following a single ascending dose (SAD) and a multiple ascending dose (MAD) design. Other studies to include in the program are drug-food interaction, bioavailability (BA) and bioequivalence (BE) studies. A radio-labeled mass balance trial (AME) is performed as early as possible in the development program to learn about the different routes of metabolism and excretion of the compound.

Together with data on in vitro metabolism (e.g. substrate of CYP3A4, CYP2C9), genetic polymorphism (e.g. poor or extensive metabolizers of CYP2D6) and information on comedication frequently used by the targeted population, an array of clinically relevant drug interaction studies is proposed. The pharmacological action of drug metabolites also needs to be evaluated. The degree of protein binding of the compound is also important to know.
Depending on the pharmacokinetics of the compound and the intended label claims, studies in special populations (e.g. patients with impaired liver function, pediatrics, elderly patients) can be planned for.

The proof-of-principle study and subsequent Phase II/III studies are performed to learn about differences in pharmacokinetic properties between healthy subjects and patients, and about patient characteristics that influence the pharmacokinetic behavior of the compound. In Phase II and III this often based on limited blood sampling strategies.
Early information on the relationships between drug exposure and efficacy/safety (or dose-response curve) can help to better select the most optimal clinical dose for Phase II/III.

Kinesis can also coordinate the execution of the trials that are part of the proposed clinical development program (see Project coordination).

Lastly, Kinesis can be consulted if there are specific questions that need to be addressed by the Drug Development Project Team.

Address:

Lage Mosten 29
4822 NK Breda
The Netherlands
+31(0)76 54 80 666
+31(0)76 54 21 777 (Fax)

(c) 2003-2004 Kinesis, the Netherlands
info@kinesis-pharma.com