Russian medical translation agency MedTran
medical translation services in Russia Clinical pharmacological trials medical translation services in Russia medical translation services
medical translation services in Russia
medical translation services COMPANY PROFILE
  medical translation services
  SERVICES
  medical translation services
  QUALITY
  high quality medical translation
  CLINICAL TRIALS
  clinical trial translations
  INFO
  medical translation
  CLIENTS
  medical translation
  CONTACTS
  medical translations
  RUSSIAN VERSION
  medical translations into Russian
 
Site search

Phases of Clinical Trials

A clinical trial of pharmaceutical product is a long-term process. A study can take several years. Depending on stage of development, it is divided into phases. There are four main phases of clinical trials:

Phase I

Phase I is the first test of a drug in humans, generally in healthy volunteers (no less then 10 subjects). These trials are often called clinical pharmacological trials as they are designed to establish the safety, tolerability, therapeutiс action, pharmacokinetic and pharmacodynamic characteristics, and sometimes the initial efficacy rate in humans.

Phase II

In Phase II, a drug is evaluated for its efficacy and safety in patients with specific diseases. As a rule, these are placebo - controlled trials. Sometimes, Phase II of a clinical trial is divided into phases IIa and IIb. The purposes of Phase II trial are to evaluate short-term safety of a drug (IIa) and to confirm clinical efficacy of a drug and determine the therapeutic dose range (IIb).

Phase III

In Phase III clinical trials, the study drug is given to large groups of patients (thousands of subjects) of different age groups, with different concomitant diseases. These trials are conducted at multiple scientific research sites in different countries. Phase III trials are often randomized controlled studies. These trials investigate all aspects of treatment including assessment of risk / benefit ratio. According to the results of Phase III clinical trials, the decision on registration of the drug product or refusal in its registration is made. Phase III of a clinical trial may be divided into phases IIIa and IIIb as well.

Phase IV

A Phase IV clinical trial is performed after a drug product has been approved. These trials are often called post-marketing (post-registration) studies. The purposes of these trials are to identify differences between a new pharmaceutical product and other drugs in this pharmacological group, to compare its efficacy with already marketed analogs, and to demonstrate a new drug benefit in relation to health economics and to identify and determine previously unknown or ill-considered side effects as well. As a result, the safety and efficacy of a drug may be reviewed periodically according to new clinical data on its use.

 
medical translations medical translations medical translation medical translation company Medtran
medical translation
medical translation Rambler's Top100
Medical translation agency MedTran
Russia, Moscow 129344, Iskra Street 17-A, build. 3
Phone: 7-(495)-542-04-49

www.medtran.ru
Russian medical translation services
medical translation services | | | | |