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  • ENGLISH
  • FRANCAIS
  • Services
    • Services Overview
    • Clinical Trial Operations
      • Protocol Development and Study Design
      • Feasibility and Study Start Up
      • Patient Recruitment
      • Project Management
      • Clinical Operations
      • Centralized Monitoring
      • Decentralized Clinical Trials (DCT)
      • Centralized eTMF
      • Medical Services
    • Regulatory and Drug Development Consulting
      • Clinical Strategy
      • Nonclinical
      • Chemistry, Manufacturing, and Controls (CMC)
      • Regulatory Affairs
      • GxP Strategy Consulting
      • Publishing and Submissions
      • Medical Writing
    • Government and Public Health Services
    • Biometrics
      • Biostatistics and Statistical Programming
      • Data Management
    • Clinical Pharmacology Modeling Simulation
      • Clinical Pharmacology Integrated Drug Development
      • Model Informed Dose & Drug Development (MIDD)
      • Pharmacometrics (PMx), Pharmacokinetics, Pharmacodynamics (PK/PD)
      • DMPK and Translational Discovery and Development
  • Therapeutic Expertise
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      • Rare Diseases and Orphan Drugs
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  1. Home
  2. Services
  3. Clinical Pharmacology Modeling Simulation
  4. Clinical Pharmacology Integrated Drug Development
    • Clinical Study Strategy and Design
    • Development and Regulatory Strategy
    • Regulatory Representation, Writing, and Submissions
    • Scientific/Technical Writing, Manuscripts, and Communication

Clinical Pharmacology Integrated Drug Development

  • Clinical Pharmacology Modeling Simulation
  • Clinical Pharmacology Integrated Drug Development
    • Clinical Study Strategy and Design
    • Development and Regulatory Strategy
    • Regulatory Representation, Writing, and Submissions
    • Scientific/Technical Writing, Manuscripts, and Communication
  • Model Informed Dose & Drug Development (MIDD)
    • Dose Translation, Rationale, and Justification
    • Bridging and Extrapolation Approaches
    • Modeling and Simulation
  • Pharmacometrics (PMx), Pharmacokinetics, Pharmacodynamics (PK/PD)
    • Data Management, Programming, and CDISC Dataset Creation
    • Noncompartmental PK Analysis (NCA)
    • Population Pharmacokinetics (popPK)
  • DMPK and Translational Discovery and Development
    • Drug-Drug Interaction (DDI) Strategy
    • Nonclinical PK, TK, and PD Analyses
    • Nonclinical Strategy, Study Design, and Analysis

Clinical pharmacology integrates numerous topics that are essential to determining a drug’s dose, designing studies, and forming an overall drug development strategy. These topics include biology, biochemistry, ADME (absorption, metabolism, distribution, and excretion), pharmacokinetics (PK), pharmacodynamics (PD), pharmacometrics (modeling and simulation), pharmacogenomics, time course of disease, human toxicology, formulation and route of administration impact, drug interactions, and specific population considerations, etc.

Our specialized focus in clinical pharmacology provides a streamlined and integrated drug development strategy by learning and confirming the science and value of the drug for patients across the entire drug development program. If done properly, clinical pharmacology is a roadmap that efficiently guides the rest of the drug development program to successful regulatory approval.

Allucent’s team of clinical pharmacology experts can guide your program from candidate selection through critical studies, driving decisions in real-time, for first-in-human (FIH), Phase 0 proof of mechanism/principle, Phase 1b/2a proof of concept, Phase 2b dose-ranging and adaptive designs, simulations for Phase 3 design options benchmarked to the standard of care, innovative regulatory strategies, quality submissions, and more with our integrated approach.

Clinical Pharmacology Integrated Drug Development Services:

  • Clinical Study Strategy and Design
  • Development and Regulatory Strategy
  • Regulatory Representation, Writing, and Submissions
  • Scientific/Technical Writing, Manuscripts, and Communications

Contact Us

Let us partner with your team on bringing new therapies to light. Get in touch to get started.

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