Page 30 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

phase can be done in other groups of population that have never
been studied. Bioequivalence and bioavailability study also falls
under this category.

10.1.3 Special Studies

Bioavailability / Bioequivalence studies - Bioequivalence
studies should be carried out for all new drug substances intended
for systemic absorption and if applicable with the available doses
formulations which are approved elsewhere in the world. For drug
not intended for systemic absorption, data on the extent of systemic
absorption may be required. Effect of food on absorption following
oral administration should also be evaluated. These studies are
conducted most often in normal volunteers. Hence, all safeguards to
protect participants must be in place, including ethical review of
protocol, recruitment methods, compensation for participation,
evidence of non-coercion and consent procedures. It is in such
studies that volunteers often participate at short intervals and may
participate at different centers within less than the prescribed
period of three months between two studies. Mechanisms to prevent
this must be developed at the study site.

10.1.4 Dissolution studies:

Dissolution is a process in which a solid substance solubilizes in a
given solvent. In the pharmaceutical industry, drug dissolution
testing is routinely used to provide critical in vitro drug release
information for both quality control purposes and drug
development. In vitro drug dissolution data generated from
dissolution testing experiments can be related to in vivo
pharmacokinetic data by means of in vitro-in vivo correlations.
Dissolution and bioavailability data submitted in the new drug
application must provide information that assures bioequivalence
or establishes bioavailability and dosage correlations between the
formulation(s) sought to be marketed and those used for clinical
trials during clinical development of the product. Data regarding
interaction of the new drug with drugs that are likely to be used
concomitantly with it are required to be conducted and should be
submitted from non-clinical studies and, if appropriate, from
human studies.

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 26