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Clinical Pharmacology and Pharmacometrics

Differentia Biotech provides clinical pharmacology and pharmacometrics services, including the implementation and interpretation of preclinical and clinical pharmacokinetic study data, pharmacometrics, modelling and simulation, guidance on protocol creation, and implementation of research studies and clinical trials. We leverage relevant pharmacological mechanisms to make informed decisions.

Facilitate Decision-making in the Success of Clinical Research

Our Expertise

Utilizing extensive knowledge of drug mechanisms, PK, PD, and MIDD methodologies, we enhance clinical trials with simulations, and can propose dosing regimen optimization in subgroups like children. 

We guide market strategies from lead selection to late-stage development, develop effective strategies for meeting regulatory obligations, and optimize study approaches. 

Our expertise spans paediatrics, maternal-foetal medicine, oncology, immunological diseases, biologics, and rare diseases. 

Clinical Pharmacology

Support for Phases I, II, and III of clinical trials, in addition to Special Population and First-in-Human (FIH), Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), Drug-Drug Interaction (DDI), Bioavailability/Bioequivalence (BA/BE), and Food Effect.

  • Design dose selection strategy
  • ADME studies
  • PK analysis, interpretation and reporting
  • Aid in paediatric drug development (PSP or PIP)
  • Provide initial concepts through New Drug Application (NDA)
  • Assistance with regulatory compliance
  • Assess market/clinical needs

Pharmacometrics

Enhance drug development success with quantification of exposure-response to optimize clinical trials in time and resources, by preventing adverse events and providing the right dose to the right patient.

  • Non compartmental analysis (NCA)
  • Pharmacokinetic (PK) models
  • Pharmacodynamic (PD) models
  • PK/PD models
  • Optimal design
  • Longitudinal disease modeling

Paediatric expertise

We are experienced in providing full service consultative service crossing the research continuum in the following main areas

  • Focus on special populations
  • Maternal and Child Health
  • Human growth and development
  • Newborn and Neonatal Individuals
  • Pediatrics
  • Chronic medical conditions arising in childhood including:
  • Congenital heart disease
  • Cystic Fibrosis
  • Asthma
  • Cancer
  • Adolescents
  • Puberty
  • Obesity
  • Obstetrics and Gynecology
  • Young Adults
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