We answer on most popular and interesting questions about pharmacovigilance
Bioavailability of medicines
Bioavailability is the amount of a therapeutically active substance that has reached the systemic bloodstream and has become available at the place of application of its action. Bioavailability is also one of the essential parameters used in pharmacokinetics, taken into account when calculating the dosage regimen for routes of [...]
Outstaffing an qualified person for pharmacovigilance
Our company offers such services as outstaffing of qualified persons for pharmacovigilance (QPPV/LCCPV) The main purpose of outstaffing service is to solve the issues associated with the optimization of staffing and with the operation of the company's budget, as well as reducing the risks associated with the resolution of [...]
Pharmacovigilance: on the formation of periodic updated safety reports
Currently, the development of analytical databases on the Internet makes it possible to determine the relevance of certain keywords. Among others, "pharmacovigilance, cheap" and "full range of pharmacovigilance services" occupy quite high positions. And this is a fairly new trend. So what do users who search for "pharmacovigilance, cheap" or [...]
Composition of a registration dossier
Our company can perform:- preparation of drug samples for evaluation during state registration,- writing sections 2,4-2,7 of the registration dossier,- amending the already submitted documents,- advising on the preparation of the dossier,- if necessary, to finalize the documents.At the time of submitting an application for state authorization of a medicinal [...]
Boequivalence studies
Bioequivalence (pharmacokinetic equivalence) is the degree of similarity of a pharmaceutically equivalent drug to a reference drug (usually a generic drug to an original proprietary drug). Determined experimentally, in vivo. As you know, after the development and registration (authorization) of a medicinal product, the product enters the pharmaceutical market. The [...]
Medicinal product authorization
In order for a drug to enter the Russian market, it is required to go through several stages, the very first of which is an affirmative registration, or revision examination. The process involves checking your product by the state for safety, efficacy in relation to the indicated pharmacological properties. The [...]
National Pharmacovigilance center is an adherent of the process approach
The process approach is the most effective method of organizing the effective work of the company, starting from the late 70s of the last century to the present, and there is every reason to believe that it will remain so for a very, very long time. The essence of the [...]