Bioequivalence

More than 70 different molecules have been tested by CROss Alliance™ in bioequivalence (BE) studies carried out in healthy volunteers for the clinical development of ethical or generic drugs. In these studies small & high molecular weight compounds, endogenous substances, pro-drugs and locally active drugs were investigated.

Thanks to the in house availability of senior biostatisticians and pharmacokineticists, CROss Alliance team is able to advice its Clients in the selection of the most suitable BE study design (parallel, cross over, replicated, two-stage) for each molecule considering the specific regulatory framework (EMA / FDA) and maximising the possibility of success.

CROss Alliance clinical team has deep expertise in most administration routes: intravenous (bolus or infusion), subcutaneous, intramuscular, oral, epicutaneous, vaginal and rectal which do not represent an obstacle neither for the performance of the studies nor for the recruiting of subjects. Moreover, all relevant pharmaceutical forms have been tested at CROss Alliance clinical unit: solutions, suspensions, capsules, tablets (ODT, IR, MR), granules, films, creams, gels, transdermal plasters or patches and suppositories.

Molecules investigated in clinical BE studies

 

Acarbose Doxycicline Manidipine Prochlorperazine
Acyclovir Emedastine Meclofenamate Propafenone
Alendronate EPA / DHA Melatonin Propionyl-L-Carnitine
Amoxycilline Fentanyl Meloxicam Riluzole
Benserazide Filgrastim Mesalazine SAMe
Bosentan Finasteride Metformin Sildenafil
Budesonide Flurbiprofen Methylprednisolone Tacrolimus
CaCO3 Folic, 5-MTHF Metoprolol Ticlopidine
Codeine Fosfomycin NAC Tobramycin
Calcitriol FSH Naproxen Tolmetin
Canrenoate Gabapentin Netupitant Tramadol
Clodronate Glibenclamide Nimesulide Trazodone
Clozapine Ketoconazole Octreotide Triflusal
Cysteamine Ketoprofen Omeprazole Tyroxine
Diazepam Ibuprofen Oxibutinin UDCA
Diclofenac Levodopa Palonosetron Xipamide
Diltiazem Levodropropizine Paracetamol  
Desmopressin Loperamide Prazepam  


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