Clinical Pharmacology and Drug Development

Everest provides a full range of Clinical Pharmacology and Drug Development services, which includes but is not limited to the following:

  1. Non-compartmental analysis (NCA)
  2. PK/PD data analysis, modeling and simulation
  3. PopPK data analysis, modeling and simulation
  4. Bioequivalence evaluation
  5. Study design and sample size input
  6. Protocol development with PK component
  7. Statistical Analysis Plan (SAP) or PK Analysis Plan (PAP) development
  8. PK report writing
  9. Clinical trial summary preparation and support
  10. Clinical drug development consultation (PK and PD) and support

Everest has been involved in conducting analysis for numerous types of studies, including:

  1. Dose proportionality and dose escalation
  2. Food interaction
  3. Drug-drug interaction (DDI)
  4. Bioavailability (BA) and bioequivalence (BE)
  5. Blood, cerebral spinal fluid, urine, tissue PK
  6. Transdermal, intramuscular, intravenous, subcutaneous, oral, intranasal, and inhalation products
  7. Biologics, liposomals, nanoparticles, solids, liquids, suspensions, and patches
  8. Immediate release, modified release, and depot

Everest uses Phoenix WinNonlin to conduct pharmacokinetic (PK) and pharmacodynamic (PD) analysis, modelling and simulation, and non-compartmental analysis (NCA).

Population pharmacokinetics and in vitro-in vivo correlations have also been conducted. Everest uses the software package NONMEM (non-linear mixed effects modeling) for these analyses.

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