Kralteramon
Member
Nice one. I didn't fully read everything yet but I will. Really interesting."Clown" huh? Do I know you?
It's not my "conclusion" that's the comedy here, it's deciding to put your ignorance on public display.
Every batch of pharma rHGH is tested for potency, separate from "purity", because not all rHGH is active.
“For somatropin-containing medicinal products, the biological activity (potency) shall be determined using a validated bioassay and expressed relative to the WHO International Standard in International Units (IU), in order to ensure comparability with the reference product.”
"“Accurate determination of biological activity is essential in the development, registration, and quality control of rhGH pharmaceutical products…"
What we can replicate by ourselves:
PK studies focussed on IGF1 response
IGF-1 is the
preferred pharmacodynamic marker for the activity of somatropin and is recommended to be used in
comparative pharmacodynamic studies.
What I don't understand:
In order to compare differences in biological activity between the similar and the reference medicinal
product, data from comparative bioassays should be provided, including receptor-binding studies and
functional assays (e.g. cell proliferation assays in human cell lines). Wherever possible, analytical
methods should be standardised and validated according to relevant guidelines.
How would one conduct a receptor binding study or test for receptor binding? And functional assays?
