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Antifungal Services

Antifungal Preclinical Services

Antimicrobial Activity in Vitro
  • Antifungal susceptibility testing (AST) CLSI and EUCAST based:
    • Minimum inhibitory concentration (MIC)

    • Minimum fungicidal concentration (MFC)

    • Minimum effective concentration (MEC)

  • Testing of drug combinations
  • Time-kill assay (microbial kill curves)
  • Post-antimicrobial effect (PAE)
  • Nail penetration assay including lacquer effect on drug penetration
  • Keratin binding assay
  • Biofilms prevention and treatment assays
In Vivo Testing (Small Animals)
  • Immunocompetent and immunosuppressed models:
    • Mice:
      Invasive candidiasis, Invasive mould infections (aspergillosis, fusariosis, mucormycosis), Mucosal (oral and vaginal) candidiasis, Wound infection model, Subcutaneous device-associated microbial biofilms, Keratitis (Fusarium, Candida, bacterial)
    • Guinea Pig:
      Onychomycosis (topical and oral dosing), Invasive and cutaneous candidiasis
    • Rabbit:
      Invasive candidiasis, Biofilms-associated infections
Mechanism of Action (MOA)
  • Effect on microbial ultrastructure/morphology/architecture
  • Inhibition of cell wall synthesis/cell wall damange
  • Lysis of cell membrane
  • Protein synthesis
  • Inhibition of DNA or RNA replication
  • Assessment of potential to develop resistance

Antifungal Clinical Services

Clinical trial support
  • Central lab for single and multi-site clinical trials both national and international

  • Assist in selection of optimal clinical sites

  • Implementation of clinical protocols

    • Protocol-related training, Fungal isolate storage, Close interactions with site Principle Investigators (PI) and staff, Data integrity maintained in collaboration with other CROs

Assays Performed
  • KOH/Fluorescent (Calcoflour) direct smear

    • Results sent within 24 hours

  • Culture and identification of fungi

    • Specimen-collection kits provided, Shipping material provided compliant with the International Air Transport Association (IATA)

  • Antifungal susceptibility testing

    • Baseline and end-of-study isolates that allows monitoring of resistance development

Data Management
  • Comply with information technology rules/regulations

  • All data are firewall and password protected

  • Data stored in 21 CFR part 11-compliant database

  • Redundant data backup procedures in place

Regulatory Services
  • Provides assistance with research design and regulatory compliance in accordance with IRB and Federal requirements