Pharmacokinetic Studies / Drug-Drug Interaction Studies
Pharmacokinetic studies (PK) are impactful in the launch of life-changing medical treatments.
To accurately evaluate PK behavior throughout all phases of the medicine development stages, at 3S Pharma we have created unique study designs for assay development, validation, and implementation in order to obtain important data, such as: absorption, bioavailability, clearance, half-life, Cmax etc.
Our goal is always to create tailored study designs that optimize dosing regimens, predict human PK from preclinical data, and address specific client needs (e.g., drug-drug interaction studies or bioavailability assessments). This expertise minimizes risks and accelerates development timelines.
Our PK services support pre-clinical and clinical research, including multi-site studies, conducted anywhere in the world.
Why choose 3S Pharma as your new long term partner
Advanced bioanalytical laboratory with over 200 validated methods
3S Pharma’s bioanalytical laboratory is equipped with high-sensitivity instruments, including High-Performance Liquid Chromatography-Mass Spectrometry (HPLC-MS/MS) and Inductively Coupled Plasma-Mass Spectrometry (ICP-MS), specializing in analyzing small molecules, peptides, large molecules, and chiral compounds. The laboratory has over 200 validated bioanalytical methods, ensuring a large amount of PK data.
Experienced scientific team with +25 years of experience
3S Pharma’s senior researchers have more than 25 years of experience in bioanalytical and mass spectrometry, with a dedicated internal unit for pharmacokinetic and biostatistical data handling. This team supports PK/PD study design, non-compartmental analysis (NCA), and statistical reporting.
Proven regulatory compliance with global inspections
3S Pharma’s clinical and bioanalytical facilities have undergone over 18 GCP inspections by European authorities (e.g., France, Germany, Austria, EMA) and FDA inspections in Moldavia (2013, 2023) without Form 483 observations. The analytical laboratory is GLP-certified, and clinical facilities are ISO 9001:2008-certified.
Owned clinical facilities and large patients capacity
3S Pharma has 2 owned medical facilities in Romania and Moldova that allow us to safely operate Phase I-IV clinical trials. With 160 total beds, we are able to handle large PK studies involving hundreds of subjects.
Also, through our large database of healthy volunteers as well as patients with chronic diseases, we are able to order and select specific pathologies.
Fast Track Approvals
Experience expedited regulatory approval in Moldova just 2 weeks from submission.
Multidisciplinary facilities
The facilities support diverse administration routes (e.g., oral, transdermal, inhalants) and are equipped with advanced infrastructure like -80°C freezers and two emergency departments.
In the search of a new CRO for your Pharmacokinetic studies?
