1․1 Pharmacokinetic studies.
- Bioavailability studies
- Bioequivalence studies
Bioequivalence studies have become an essential requirement for registering new pharmaceutical products in markets across the world. We conduct cost-effective and high quality bioequivalence studies in short period of time.
BE Studies are conducted at Tonus-Les LLC are in strict Compliance with International Regulatory Requirements, monitored by an independent quality assurance department.
We provide full CRO service to conduct bioequivalence studies. We aim to become a valued partner for your pharmaceutical product research, development and registration.
PK studies in healthy volunteers: we can work with as many as 34 volunteers per study.
Types of dosage forms:
- oral tablets
- ODTs (orally disintegrating tablets), lozenges and drugs with sub-lingual administration
- syrups and suspensions for oral administration
Our bioequivalence services include, but not limited to:
- Protocol, CRF, ICF and other required documents’ development, review and management
- Ethics committee and regulatory authority submissions
- Translation of all pharmacokinetic study documents (to/from Armenian, English and Russian) according to the current medical terminology, including quality checks
- Assistance in obtaining local insurance
- Oversight of the pharmacokinetic trial for compliance with the protocol and applicable regulatory requirements
- Timely subject recruitment
- Reporting of study results
- Closing out the study and ensuring records transfer