• 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
    • Therapeutic Expertise Overview
    • By Subject
      • Oncology and Hematology
      • Rare Diseases and Orphan Drugs
      • Infectious Disease and Vaccine
      • Cell and Gene Therapy
      • Central Nervous System
      • Autoimmune and Inflammation
      • Allergy and Asthma
    • By Phase
  • Company
    • About Us
    • History
    • News
    • Events
    • Leadership
    • Mission, Vision, Values
  • Resources
    • Resource Library
    • Blog
  • Careers
    • Careers Overview
    • Job Listings
    • CRA Academy and Fellows Program
  • Contact Us
    • Contact Us
    • Request for Proposal
  • 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
    • Therapeutic Expertise Overview
    • By Subject
      • Oncology and Hematology
      • Rare Diseases and Orphan Drugs
      • Infectious Disease and Vaccine
      • Cell and Gene Therapy
      • Central Nervous System
      • Autoimmune and Inflammation
      • Allergy and Asthma
    • By Phase
  • Company
    • About Us
    • History
    • News
    • Events
    • Leadership
    • Mission, Vision, Values
  • Resources
    • Resource Library
    • Blog
  • Careers
    • Careers Overview
    • Job Listings
    • CRA Academy and Fellows Program
  • Contact Us
    • Contact Us
    • Request for Proposal
  1. Home
  2. Services
  3. Clinical Pharmacology Modeling Simulation
  4. Model Informed Dose & Drug Development (MIDD)
  5. Bridging and Extrapolation Approaches
    • Dose Translation, Rationale, and Justification
    • Bridging and Extrapolation Approaches
    • Modeling and Simulation

Bridging and Extrapolation Approaches

  • Model Informed Dose & Drug Development (MIDD)
  • Dose Translation, Rationale, and Justification
  • Bridging and Extrapolation Approaches
  • Modeling and Simulation

A modeling technique called extrapolation (also known as “bridging”) is used throughout drug development and can be particularly useful to accelerate your program and fill certain regulatory requirements or “gaps.” In some cases, bridging data can even be used to avoid a new clinical trial altogether. In these situations, preexisting data can be leveraged to support new formulations, dosage forms, dosing regimens, routes of administration, and more, without having to conduct new studies. Extrapolation using modeling and simulation approaches is used to support 505(b)(2) applications and support pediatric drug development (as illustrated below) and has been applied to many drug development strategies harnessing data for the efficient development of medicines for patients who need them.

505(B)(2) Pathway

The 505(b)(2) pathway is a streamlined NDA process in which the applicant relies upon one or more investigations conducted by someone other than the applicant. In other words, the 505(b)(2) pathway enables investigators and/or manufacturers to apply for regulatory approval without having to repeat all the drug development work done for an innovator drug, offering tremendous opportunity for sponsors.

When planning your 505(b)(2) development program, you must determine how the new drug product is different and similar to the innovator drug. From there, you can leverage all information relevant to the new drug product by creating a “bridge” linking the in vivo performance of the new drug product to that of the innovator drug product (e.g., establishing a strong PK/PD relationship, matching PK exposure and time course for the reference product, using a defined therapeutic index to assess clinical impact, and more efficient confirmatory studies). Understanding how to best link the two products is an essential step in maximizing the full streamlining capability of the 505(b)(2) approach and requires experts in these techniques to be successful.

Pediatric Drug Development

Extrapolation approaches are regularly used to assist in pediatric dose selection and to optimize trial design. For pediatrics, extrapolation aims to scale the previously established model describing the adult data to children based on body size, physiological differences, ADME, and disease features, as appropriate. This modeling approach provides a rationale for the doses by size and age to achieve similar efficacy or efficacy targets in adults. In addition, you can avoid testing uninformative and unnecessary dosing regimens in pediatric patients.

The information gained from bridging/extrapolation using modeling and simulation can lead to conducting efficient (i.e., parallel, fewer and/or shorter) pediatric studies by optimizing sampling and maximizing the information collected on a drug’s PK and PD in this population.

Bridging and Extrapolation Services: 

  • New formulations, dosing regimens, routes of administration, fixed dose combination formulations, dose and device combinations, etc.
  • 505(b)(2) applications
  • Pediatric dosing and development
  • Biosimilars
  • Leveraging mechanistic and competitor data
  • Other specific populations such as pregnant and breast-feeding women, elderly, patients with renal impairment or hepatic impairment, and more.
  • Over the counter products
  • Ethnopharmacology bridging     

Contact Us

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

CONTACT US

  • Services
    • Clinical Trial Operations
    • Regulatory and Drug Development Consulting
    • Government and Public Health Services
    • Biometrics
    • Clinical Pharmacology Modeling Simulation
  • Therapeutic Expertise
    • Oncology and Hematology
    • Rare Diseases and Orphan Drugs
    • Infectious Disease and Vaccine
    • Cell and Gene Therapy
    • Central Nervous System
    • Autoimmune and Inflammation
    • Allergy and Asthma
  • Company
    • About Us
    • News
    • Events
  • Privacy Policy
  • English
  • Francais

© 2023 Allucent. All rights

North American Headquarters
2000 Centregreen Way
Suite 300
Cary, North Carolina 27513
+1 919-361-2286

United Kingdom Headquarters
1st Floor, One Station Square,
Bracknell, Berkshire
RG12 1QB United Kingdom
T: +44 (0) 1344 891121
F: +44 (0) 1344 890335

European Headquarters
Stationsplein Noord-Oost 438
1117 CL Schiphol
The Netherlands
+31 20-4350-580