Clinical Pharmacology & Pharmacometrics

We deliver expert Clinical Pharmacology and Pharmacometrics solutions that optimize dose selection, streamline study design, and ensure regulatory-ready outcomes.

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A Trusted Partner for
PK/PD Excellence

With proven expertise in complex PK/PD analyses, Everest supports pharmaceutical and biotech partners in making data-driven decisions to deliver safe and effective therapies to patients. Our analyses are designed to meet global regulatory standards, providing clear, well-supported results for confident submissions and reviews.

What We Offer

At Everest, we provide a comprehensive suite of Clinical Pharmacology and Drug Development services to support every stage of your drug development program. Our Clinical Pharmacology and Pharmacometrics services include:

  • Non-compartmental analysis (NCA)
  • Compartmental/population PK analysis, modeling, and simulations
  • Concentration-QTc (C-QTc) modeling
  • Dose finding/optimizations using No Observed Adverse Effect Level (NOAEL) or Pharmacologically Active Dose (PAD) or Minimum Anticipated Biological Effect Level (MABEL) evaluations
  • Dose proportionality assessments
  • Bioequivalence and bioavailability evaluations
  • Abuse liability/potential assessments
  • Exposure response/exposure safety (ERES) analyses
  • Study design optimization and sample size calculations
  • Protocol development with PK components
  • Statistical Analysis Plans (SAP) or PK Analysis Plans (PAP)
  • Comprehensive PK report writing
  • Clinical trial summary preparation and regulatory support
  • Exploratory PK/PD analyses and competitor/intelligence analysis and reporting
  • Expert consultation on PK and PD strategy throughout drug development

Our Experience & Expertise

Everest has extensive experience conducting PK/PD analyses across a wide range of studies.

Study Designs:

  • Dose escalation studies
  • Food-effect and drug-drug interaction (DDI) studies
  • Special populations
  • Organ impairment (hepatic and renal impairment PK) studies
  • Bioavailability (BA) and bioequivalence (BE) studies
  • Evaluations across various biological matrices, including blood, cerebrospinal fluid, urine, and tissue

Administration Routes:

  • Transdermal
  • Intramuscular
  • Intravenous
  • Subcutaneous
  • Oral
  • Intranasal
  • Inhalation

Drug Formulations:

  • Biologics, liposomal formulations, nanoparticles, solids, liquids, suspensions, and patches
  • Immediate-release, modified-release, and depot formulations

Why Choose Everest for
Pharmacology and Pharmacometrics?

Deep Expertise

Our team has years of experience in clinical pharmacology and PK/PD modeling, ensuring scientifically rigorous, regulatory-compliant analyses.

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