Bioequivalence and Bioavailability Forum

Dear All

I have some queries in bioequivalence studies of hormone replacement therapy preparations in postmenopausal females:

1. In most of the published literature the inclusion Criteria considered are: female subjects who are in good health within 45-65 years of age and are in postmenopausal phase (i.e. history of permanent cessation of menstruation at least for the last one year) with &#61538;-estradiol levels <20 pg/ml and FSH > 40 IU/ml. But it is difficulty to get volunteers with &#61538;-estradiol levels <20 pg/ml and FSH > 40 IU/ml. Normal range of &#61538;-estradiol for postmenopausal females is 10.0-44.0 ng/ml and of FSH levels is 17.0-95.0 mIU/ml. Then what levels should we consider for &#61538;-estradiol and FSH in studies of postmenopausal females.

2. What should be the range for BMI as it is difficult to get BMI between 18 and 25 in that age group.

3. Usually subjects with normal blood pressure (systolic blood pressure > 100 or < 140 mm of Hg or diastolic blood pressure > 60 or < 90 mm of Hg) are included but in this elderly age group many females will be having hypertention and will be taking medicines for the same. What should be the upper limit of blood pressure and should we allow them to continue taking their antihypertensive drugs as we donot include volunteers taking any medications in bioequivalence studies to avoid any intractions.

4. What about subjects having diabetes and taking medicines for the same.

Please suggest.


Thank you
Regards
Dr Muneesh Garg

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Edit: Category changed. Please don't use UTF-8 coded characters (see the 'Instructions for Use'). Please edit your post within the next 24 hours to change the character '&#61538;' (since it's in the 'private area' of UTF, I'm not sure which symbol you wanted to display - 'beta'?). [Helmut]