Аутсорсинг в клинической лаборатории

Bioequivalence (PHARMACOKINETIC EQUIVALENCE) – the degree of similarity of a pharmaceutically equivalent drug to a reference product. It is determined experimentally, in vivo. The main BE criteria – extent and rate of drug absorption, time to achieve the maximum blood concentration and its values, type of a drug distribution in body tissues and fluids, type and rate of a drug elimination. .

First-in human studies to test a candidate drug. During the studies, the following is established: tolerability and safety, effect on the main physiological parameters, elimination, absorption and excretion rate constants, peak serum concentration, time necessary to achieve the maximum concentration, metabolism and interaction, half-life period, pharmacokinetic and pharmacodynamic values, protein binding, comparison of dosage forms, area under the “concentration – time” curve (AUC), activity.
First controlled studies in a small number of patients to establish a therapeutic drug effect. During the studies, drug safety and tolerability is established, drug efficacy, effective dosage are determined, and frequency of administration is selected.
Multicenter studies in various populations of patients are carried out to prove drug efficacy and safety.
Studies of drug products are carried out after drug registration. The studies are carried out for: expansion of the therapeutic profile of drugs, obtaining additional efficacy information (various dosage forms, doses, treatment regimes and duration, drug interactions, new groups of patients), identification and characteristics of previously known adverse reactions and risk factors.
Pоstmarketing studies – “marketing observational studies” which are used for descriptive clinical studies to differentiate them from well-controlled IV phase clinical studies. The studies are carried out to maintain marketing. Epidemiological studies – the combination of methodical methods allowing to asses structure of population morbidity per groups and nosologies, reveal causality between development and manifestations of various diseases used in public healthcare.
Vita Aeterna company develops a full package of documents for all types of clinical studies. Our aim is to provide an optimum solution for the conduct of clinical studies for further registration of a study drug.
Vita Aeterna company provides services of obtaining approval for clinical trials.
Vita Aeterna company carries out clinical trials timely, with good quality in accordance with the regulatory requirements. Project managers of Vita Aeterna company as heads of project groups coordinate and manage projects fully from the beginning to completion. Project managers of our company are the first and main contacts for a customer.
Clinical trial specialists of Vita Aeterna company provide the full range of services on checking of subject safety, compliance with the protocol, GCP, national legislation and quality of data collection.
Vita Aeterna company provides the whole range of services on collection, transfer of information obtained in clinical studies to the electronic base for the further analysis.
Vita Eterna offers the main range of decision-making services from the point of view of statistical analysis for all stages of clinical trials and non-interventional observational studies.
Vita Aeterna company works per quality standard ISO 9001:2015. Vita Aeterna company works per own system of Standard operating procedures (SOP). On the request of a Customer and during corresponding trainings, the company can follow the customer’s SOPs. The quality Assurance Department of Vita Aeterna guarantees continued functioning of the quality control system in clinical studies in accordance with the national regulatory requirements, corporate standards of “Vita Aeterna” LLC, general ICH-GCP requirements, registration dossiers and other documents regulating pharmaceutical activity.
Vita Aeterna company offers the complex package of services for state drug registration and its confirmation, as well introduction of changes to a registration dossier of authorized drug products in Russia, Kazakhstan, Belarus, Armenia, Kirgizia with the full support of a registration process. Registration of medical devices. Registration of dietary supplements
Pharmacovigilance – the type of activity aimed to detect, assess, understand and prevent adverse consequences of drug administration.

Vita Aeterna provides the full range of preclinical study services.

We are in the strategic partnership with several preclinical laboratories.