Biomedical Engineering Reference
In-Depth Information
In order to satisfy a patient want or need, an idea must be transformed, using
defined processes so as to bring a product into being.
For pharmaceutical products under development, there are some basic rules
that must be followed during transformation of an idea into a product in order
to ensure patient protection.
1.
Products must be safe
—Clinical products can never be guaranteed as safe
with respect to their pharmacological profile as this is the main purpose
of performing the trials. The risks in controlled clinical trials are mitigated
as much as possible by prior studies (e.g., in animals). Clinical products,
however, must be safe with respect to the conditions under which they were
manufactured and controlled. This is especially true regarding the quantity
of active substance(s) that are claimed to be in them and the absence
of unexpected and potentially harmful substances/contaminants other than
those that are unavoidably part of the drug substance itself. In such cases,
the maximum permitted levels must be closely controlled. This rule arises
first from a moral obligation not to harm a patient participating in a study,
but equally from the economic reality which determines that no company
will realize a product if a patient is harmed as a result of manufacturing
errors. This can result from inaccurate formulation or analysis of their
product as well as through lack of sterility or the presence of particulate
contamination.
2.
Products should be effective
—Ideally, clinical products must be effective,
yet in many, possibly most cases, it will not necessarily be so. One of the
main reasons for conducting a clinical study is to determine whether or not
the proposed product is effective. If meaningful results are to be obtained
from a study, the amount of active substance in the trial product must be
defined and there should be a means of accurately analyzing and determin-
ing this value before the product is sent to a trial site. It is the responsibility
of the sponsor to ensure that the product distributed for human use in a
clinical trial contains the active substance(s) in the amount(s) stated on
the product label. This requires reliable and controlled manufacturing and
analytical methods even in early-phase trials.
3.
Product must meet a patient's want or need
These rules can be summarized as requiring the product to be suitable for its
purpose—that is, fit for use in the clinical trial.
In the European Directive 2003/94/EC, a definition is provided for pharma-
ceutical quality assurance:
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