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The package information leaflet(PIL) is a document that contains brief information about a medicinal product. The PIL is a mandatory document in the state registration of medicinal products for medical use. patients can easily obtain and understand the necessary information from the package insert. The key point in the development of the PIL is how…
Today we would like to talk to you about how the processes of conducting clinical trials have changed in the face of the COVID-19 pandemic. The biggest question is about the trial monitoring process. After all, the monitor personally travels to the centers and monitors the progress of the study, and now this routine process…
After a pharmaceutical company gets a registration certificate for a medicine, clinical trials continue. In this article, we will talk about post-registration studies, specifically post-registration safety studies for a drug. First, let’s define what are “Post-Authorisation Safety Studies”? According to the Good Pharmacovigilance Practices of the EAEU, a post-registration safety study (PASS) is a study…
Vaccine development today becomes especially important against the COVID-19 pandemic. Pharmaceutical companies have activated the general fight against the coronavirus. In this article, we will describe the peculiarities of clinical trials of vaccines. The widespread use of vaccines necessitates monitoring the quality and efficacy of immunizations, which is an integral part of the epidemiological surveillance…
While it may come as a surprise to majority of people, it holds true. It’s imperative to note, that not every unapproved drug out there can be used in patient treatment, and FDA itself has clear guidelines of when it’s acceptable. The exception is granted under one of the below conditions: The drug is involved…
USA Food and Drug Agency (FDA) approved Trikafta (elexacaftor / ivacaftor / tezacaftor), a first triple-combination therapy, which will be available for treatment of patients with the most common mutation in cystic fibrosis (CF). Trikafta was approved for patients at 12 years of age, or more, who have at least one copy of F508del mutation…