Clinical trials of medicinal products
Acquiring a medicine, we hardly think about how long it has overcome before getting to the pharmacy. It all starts with a scientific idea. Then the drug must go through all the stages of development and testing, which usually last from seven to ten years. Only then he gets on the pharmaceutical market.
Many people have a question: how do drugs get into pharmacies?
Before the new drug is approved for use, preclinical and clinical studies are conducted, first on animals, then on humans, if this is an innovative new drug.
What is clinical research? What is their essence?
Clinical studies of the drug are an indispensable stage in the development of any new drug, or the expansion of indications for the use of a drug already known to physicians. At the initial stages of the development of new drugs, toxicological studies are conducted on laboratory animals with the study of carcinogenicity, reproductive and genetic toxicity, the pharmacological properties and potential therapeutic effects in animal models are evaluated. These are so-called preclinical studies, the purpose of which is to obtain evidence of the safety and potential efficacy of a new drug for humans. However, only preclinical studies are not sufficient to initiate extensive medical use of a new drug in patients. Therefore, it is necessary to conduct clinical trials of medicinal products in humans.
Clinical studies consist of several phases:
• Phase I: these are the first trials of a new drug in humans, usually performed on healthy volunteers, the aim of these studies is to study the tolerability of a new drug, to study pharmacokinetic and pharmacodynamic properties, to study the safe dose range within which the drug is sufficiently well is
transferred with a single or repeated application.
• Phase II: this is the first experience of using drugs in patients with the disease, for the treatment of which it is intended to use it. Early clinical studies in Phase II are often referred to as pilot studies, as the results provide optimal planning for more expensive and extensive studies. The main objective of Phase II clinical trials is to demonstrate the clinical efficacy and safety of drugs in a particular group of patients. Additionally, the task is to determine the effective therapeutic dose of a new drug.
• Phase III: these are generally multi-center studies involving large groups of patients whose goal is to obtain additional information on the safety and efficacy of the drug. The data obtained during the Phase III trials are the basis for the registration of the drug and its resolution for broad medical applications.
• IV-th phase: conducted after registration of the drug, it is often called postmarketing research. This phase of clinical trials includes studies to obtain more detailed information on the safety and efficacy of the drug and to identify rare side reactions.
The development of new drugs is a very long and expensive process, which ultimately affects the price of new drugs. To provide patients with more affordable medicines, pharmaceutical companies develop and produce generic medicines. To register a generic medicinal product, it is necessary to conduct a bioequivalence study, where, by studying the bioavailability of generic and innovative medicines, they prove their interchangeability. These studies are usually conducted on healthy volunteers.
How to choose a drug from the set of pharmacies presented in the windows?
First of all, the drug should be prescribed by the attending physician, only after diagnosing and knowing all the accompanying diseases, the doctor can prescribe a drug that will be the most effective and safe for a particular patient, with the reception of which the possibility of development of adverse reactions will be minimal and maximum efficiency. You can not choose medicines by the principle of whether or not you liked the packaging, or on the advice of a neighbor.
Who is the customer of clinical trials?
As a rule, these are manufacturers of medicines. What researches are claimed most of all?
In my opinion, Phase III studies, on the study of the efficacy and safety of drugs, for the treatment of patients with various types of diseases.
What is the difference between DD and clinical drugs?
If you decipher a dietary supplement is a biologically active supplement, that is, it is not a drug. Drugs are always better studied than Bad. Registration of BADs is usually easier, does not require as many studies as registration of drugs. The efficacy of BA is less studied.
What are the basic rules to adhere to in a pharmacy to pick up quality medicines?
Initially, you need to go to the doctor to prescribe a prescription. And only then, by prescription, you can go to the pharmacist to select the right medicines.
Polonyuk Svetlana Nikolaevna Director of "INNOFAR-Ukraine Innovative Pharma Researches" LLC Boyany, Novoselitsky district, Chernivtsi region Tel. working +380373357019