Process of pharmaceutical
development for a new medication.
Dear
volunteers, |
Your
participation is crucial for testing new drugs on the human. You will
receive a compensation for the inconvenience and the nuisance that
might happen during the study, but your voluntary implication goes
beyond that, you will especially contribute to treat the disease of
somebody or to improve his living conditions.
When a pharmaceutical company discovers a chemical entity with a potential
pharmacological activity, and after the results obtained in the animals
are found satisfactory, it begins a clinical process on the man. The
pharmaceutical development is a very long and expensive process. At
the beginning, the test starts by aiming to study the drug behavior
in the body, to demonstrate also its safety and then its effectiveness.
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| The
clinical process on the human passes by four phases, Atlantic Life
sciences inc. is involved in the first stage, called Phase I or first
administration in man. The clinical studies of Phase I proceed in
general with the healthy volunteer, but they can take place on the
patient for whom it would not have any treatment available. The clinical
studies of Phase I are carried out with a restricted number of volunteers. |
| Once
that this stage of the clinical development of the new drug is reached
successfully, one will test it on a larger number of voluntary patients.
Thus, the safety of the new drug is still measured, but one puts the
emphasis especially on its therapeutic effectiveness. These clinical
studies are named as Phase II and then III clinical trials. When those
are crossed successfully, the drug is sold and put on the market and
available to treat patients. |
Clinical
studies can also be carried out after a drug is approved and made
available to the public. One speaks about clinical studies of Phase
IV. These studies aim to compare the effectiveness of this drug to
another medication on the market.
Sometimes, the side effects do not appear during phases I-II-III,
because the drug was tested on a small number of participants, and
also under well controlled conditions of use/treatment, but they could
be observed when the medication will be going to treat patients over
the general public.
Thus, according to the results, the drug can be withdrawn from the
market and goes back to the previous steps. Most of the time, the
manufacturer wants to see if the side effect(s) observed can not be
used to treat an other disease. This was the case of Rogaine, for
example, used for the fall of hair whereas Minoxidil compound is used
to lower the blood pressure. |
| Before
beginning with recruiting volunteers for the conduct of a Phase I
clinical study, ALS inc. develops and writes the study protocol by
scientists having the expertise confirmed in the therapeutic field
of the drug being studied. ALS inc. enforces and complies with all
the standards of
Ethical Conduct for Research Involving Humans. After the protocol
has been written and approved by the ethics committee, a representative
of ALS inc contacts the volunteers to propose to them to voluntarily
take part in the study. The medical Doctor remains available to answer
all the questions and he uses the best of the drug to be tested. |
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