ClinSync
  • Home
  • About Us
    • Core Competencies
    • Vision and Mission
    • ClinSync Values
  • Services
    • Oncology and Special Population services
    • Early Stage Clinical Development
      • Brief Overview
      • Cardiac Safety/ TQT studies
      • Facilities in General
      • Phase I
    • Late Stage Clinical Development
      • Brief Overview
      • Data Management
      • Site Management & Monitoring
      • Program, Project & Study Management
      • Temporary Staffing/Flexible Sourcing Solutions
    • Bioanalytical Services
    • DMPK Services
    • Toxicology
    • Medical Writing
    • Biostatistics
    • Quality Assurance & Regulatory Services
    • Pharmaco Vigilance Services
  • International Operations
  • Collaborations
  • Career
  • Contact
  • Search
  • Menu

ClinSync

‘DMPK services include the planning of necessary studies for regulatory filing at the appropriate time and mechanistic studies when required’

• Pharmacokinetics

– Single and Multiple Dose, Dose Proportionality, Absolute Bioavailability, PK/TK Modeling    – Mass Balance/Excretion/Radiolabel Studies
– Formulation Optimization, Intestinal Permeability, other Mechanistic studies

  – Bioequivalence analysis
– PK and PK/ PD analysis
–  In Vitro – In Vivo Correlation (with Pharsight™ IVIVC toolkit software)
– WinNonlin™ for PK analysis and SAS for statistical analysis

• Protein Binding; RBC/Plasma Distribution Partitioning

  – Protein Covalent Binding

• Tissue Distribution

  – Discovery QWBA
– Quantitative Whole-Body Autoradiography (QWBA)
– Micro-autoradiography (MARG)

• Metabolism

  – Metabolic Stability, Species Comparison, CYP450 Inhibition/Induction
– Metabolic Reaction Pathway Profiling
– Metabolite Profiling & Identification – In Vitro, Preclinical, and Clinical

End to End Services Includes

Oncology

HIV/ TB/ Malaria/ Hepatitis and other infectious conditions

Post menopausal women

Dermatology- Transdermal patches, Gel/ Foam/ Cream, Cumulative Irritation studies & Skin sensitization studies

Hepatic Impairment

Renal Impairment (at partner Kidney Center)

Hypogonadal studies

Contraceptive studies

Cardiovascular and Metabolic Diseases- Cardiac Failure & Diabetes

  • Bioanalytical Services
  • Biostatistics
  • DMPK Services
  • Early Stage Clinical Development
    • Brief Overview
    • Cardiac Safety/ TQT studies
    • Facilities in General
    • Phase I
  • Late Stage Clinical Development
    • Brief Overview
    • Data Management
    • Program, Project & Study Management
    • Site Management & Monitoring
    • Temporary Staffing/Flexible Sourcing Solutions
  • Medical Writing
  • Oncology and Special Population services
  • Pharmaco Vigilance Services
  • Quality Assurance & Regulatory Services
  • Toxicology
Scroll to top