1135my concern is the coating. you look like you are using gel caps. My understanding is that when drugs are trialled all components of the product are included as part of the “test” ie therefore if you are trying to replicate a product the filler you use needs to be consistent with the original product (ie benign regarding drug-drug interactions and most importantly approximate any effects on bioavailability of the active ingredient – because if this is altered then there are implications for dosing adjustments). Additionally if the original product has a coating – then the coating affects where in the gut the active ingredient is ultimately delivered and this again may have implications for where and therefore how much of the active ingredient gets absorbed into the system – and again for dosing adjustments. We seem to be advocating gel caps here – is BMS Daclatasvir in gel caps or coated.

Im not saying that any of these factors will have a significant effect on our “generic” approximations, – it might in this case make bugger all difference. But we don’t know so I think we need the advice of a chemist who can not only mechanically put the bits together – but one who has sufficiently advanced chemistry acumen to be able to look at the BMS Daclatasvir Analytic Profile and assure us as to what excipients and coatings (or whether gel caps are ok) to use. Im maybe too cautious but I need to get this right – Im end stage 4 and don’t need any resistance issues but Im unlikely to get a second shot at this if I proceed. regards all Archer