Abstract book 6th RMS 16.indd

efficacy profiles for unlicensed and off-label
medicine use in children. The methodology
is also currently being extended to allow
evaluation of the toxicokinetics of
excipients used in paediatric medicines and
to the assessment of adherence of children
to prescribed medicines in primary care.
437
A Pharmaceutical Perspective of
the Treatment of Type 2 Diabetes in
Kerala State, India
Ian L Naylor*, MJ Sreenilayam, ILNaylor & S
Sreenath
* Dr, Senior Lecturer in Pharmacology, School
of Pharmacy, University of Bradford, Bradford
UK
ian.naylor@bradford.ac.uk
Objectives: The present and future
incidence of Type 2 diabetes in India
is of serious concern . This study was
designed to investigate how patients drug
treatment, diet and lifestyle affected their
ability to control their blood sugar values.
Methods: 131 randomly selected patients
were asked to complete a questionnaire
which included questions about their
family history, age of first diagnosis,
blood sugar levels, current drug regimens
and diet as they attended their routine
1-3 month appointments in clinics in
Trivandrum, Kerala state. Blood sugar
levels were measured both fasting and non
fasting states in all the participants. Where
possible responses were analysed using
SPSS (version 19).
Results: A positive family history occurred
in 65 patients (50%) and the median age
of first diagnosis was between 50-64
years. Very few patients actually knew their
blood sugar levels and when measured
the median fasting level was 6.99 mmol/l
[range of 4.2 to 14 mmol/l ] and the
median non fasting levels was 10.84
mmol/l [range of 6.8 to 16.3 mmol/l]. All
patients were taking medicines to alleviate
their condition the majority (49/131) were
taking glibenclamide and 34/131 were
actually using insulin and 46% were also
using Ayurverdic preparations. Dietary
patterns were very variable throughout the
131 patients.
Conclusion: Even in closely monitored type
2 diabetes patients in Kerala state blood
sugar control was less than adequate. The
significance of this will be discussed
438
Bioequivalence Studies Regulation
in Jordan
Rawan S. Al-Hiyari MSc Pharm, Jordan Food
and Drug Administration, Registration Department
(Jordan)
rawan.al-hiyari@jfda.jo
Objectives: Bio equivalence studies for
generic drugs is an essential and a prior
requierment for drug registration in Jordan
since 2000. Both local and foreign generic
drugs evidence their efficacy and safety in
order to be eligible for further assessment
for thier quality through a suitable design
and kind of study . The aim of presentation
is to provide a review of the current JFDA
bio equivalence guideline
Methods: Bio equivalence studies are
submitted with the common technical
document CTD and undergo evaluation
through qualified committee according
to Jordanian FDA guideline . The
submission,evaluation and approval
process criteria and statistical date will be
presented
Results: All generic drugs submitted
to JFDA undergo evaluation according
to Jordanian FDA guideline which is in
parallel with international (FDA, EMEA,...)
regulations and updates. Statistics showes
the number of CTD files submmied and
the bio equivalence and bio waiver studies
required accordingly and the percentage of
accepted and rejected studies and discuss
rejection criteria.
Conclusion: The current guideline for
bioequivalence evaluation studies ensure
the safty and efficay of generic drug
submitted in jordan Which is equivalent to
international regulation
213 www.jrms.gov.jo