When does a pharmaceutical company recall medication?
This is how a new drug is created
Then, if the results are good, the drug can be approved. The studies are called "clinical" even if they are not carried out in clinics but by doctors in private practice; however, this is rather the exception.
Pharmaceutical companies plan and organize their studies themselves or commission clinical research organizations (CROs) to do so. These companies, which specialize in clinical studies, then take care of the organization, implementation and, if desired, the evaluation of the studies in close cooperation with their client. Many are internationally active because medical institutions from several countries are involved in most studies at the same time.
The approval of the competent national authority (ies) and the ethics committees is required for each study. Ethics committees consist of experienced medical professionals, theologians, lawyers and lay people. You weigh (based on the previous studies, among other things) whether and under what conditions the planned study can be carried out from an ethical, medical and legal point of view. You pay particular attention to the protection of the participants. They also check whether the medical institutions and their doctors who want to participate in the study are suitable for the study.
Any subject (healthy volunteer) or patient interested in participating must be fully informed about the planned study and possible risks. Anyone who then decides to participate gives their consent in writing (informed consent), which they can revoke at any time without giving reasons. If there are unacceptable side effects during the clinical study or if the effectiveness is insufficient, the study will be discontinued.
A test person is participating in a phase I study. A recorder on her belt records important measurement data. Doctors supervise the experiment.Phase I: First testing with healthy people
In phase I, the drug candidate is first tested with healthy volunteers, the test subjects. With healthy people, of course, you cannot tell whether it is working. Rather, up to 30 successive studies are first tested to determine whether the predictions from animal experiments about uptake, distribution, conversion and excretion in humans are confirmed. It also registers exactly how well the drug candidate is tolerated. The test persons receive a fee for the time invested and the inconvenience (for example blood sampling). In the course of phase I, 60 to 80 test persons are typically involved.
Based on the data from the phase I studies, so-called galenic experts develop the dosage form with which the active ingredient becomes the actual drug. Most often this is a tablet; However, a capsule, an injection or infusion solution, an ointment or cream, an inhalable aerosol, an active substance plaster, a granulate for the preparation of a drinking solution and many other forms, which are determined before the drugs are approved, are also considered. .
The dosage form makes a significant contribution to how quickly and reliably an active ingredient reaches the parts of the body where it is supposed to work. You can give him escort, for example protect him from being destroyed by gastric juice, or open doors into his body, for example make the skin permeable under an active substance plaster. Some dosage forms reduce side effects or ensure that the active ingredient does not pass into the blood immediately after taking the medication, but rather over many hours. Developing the final combination of active ingredient and excipients is often as complicated as developing the active ingredient itself.
Phase II and III: trials with patients
In phase II, patients are included for the first time; Manufacturers or CROs cooperate with clinics and other medical facilities. Their doctors then ask patients about the possibility of participating in the study and also carry out the treatments as part of the studies. Typically 100 to 500 patients are involved in a phase II study. On the one hand, it is checked whether the desired treatment effect is shown. On the other hand, attention is paid to side effects and it is determined which dosage is most suitable.
In phase III, doctors then test the drug on thousands of patients to see whether efficacy and safety can be confirmed in many different patients. Interactions with other drugs are also examined.
In phase II and phase III studies, differently treated patient groups are always compared. Typically, one group receives the new drug, another the previous standard preparation. In other cases, both groups receive the same basic drug treatment, with one group also receiving the new drug, the other a replica of the new drug without active ingredient, a so-called placebo. Such comparative studies are also called controlled studies.
If possible, the patients are distributed randomly (doctors speak of randomized) between the two groups. If neither the patient nor the treating physician know who was ultimately assigned to which group, such studies are called double-blind. The drug packs then only have code numbers that are noted in the patient files. Only after the treatment are they "deciphered" and the results of both patient groups compared. This procedure is intended to prevent hopes or fears about the medication from affecting the treatment result.
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