Bioequivalence Services

  • Performing high quality Bioavailability & Bioequivalence Studies compatible with ICH guidelines , and Egyptian guidelines
  • In-vitro dissolution (Biowaiver studies) : performing comparative in-vitro dissolution studies compliant with ICH guidelines and Egyptian guidelines in three dissolution media in addition to suitable pH medium(FDA, USP recommended)
In addition to our help services in producing comparative in-vitro dissolution for trial batches prior to production phases.
  • Protocol development: Establishment of protocol design that is compliant with FDA , ICH guidelines Institutional Review Board: The Institutional Review Board of ARC will review the protocol ,The Board is constituted and operates in accordance with the principles and requirements described in Guidelines on research Involving Human Subjects. All amendments to the study protocol are to be sent to the IRB for approval.
  • Bioanalytical methods development and validation of drug(s) and metabolite(s) Our professional analytical staff makes possible to develop, validate bioanalytical methods and analyze biological samples coming from your bioequivalence clinical trials.
  • Pharmacokinetic Studies
  • Clinical trials