RRD MODEL AND SERVICES

Clinical Pharmacology and Pharmacometrics

RRD Partners benefit from having a fully engaged, seasoned team on day 1, with expertise across all stages of development and product types, including NCEs, Repurposed NCEs, 505(b)(2)s, Biosimilars/Biobetters, Companion Diagnostics, and Combination Products.

Value

Accelerate development

Avoid missteps

Address Phase 1 liability

De-risk asset

Improve asset value

Clinical Pharmacology Service Areas

Drug Development Capabilities

  • In vitro screening studies
  • Phase 1 program development
  • Phase 1 study design and execution (synopsis, protocol, oversight, and CSR)

Regulatory Affairs Support

  • Pre-clinical and clinical trial application package development and meeting attendance
  • EOP1/EOP2/Type A/Package and meeting attendance

Marketing Authorization Strategy and Submission

  • Pre-clinical and clinical trial application package and meeting attendance
  • Marketing application filing and regulatory liaison
  • Product labeling development
  • Advisory committee presentation
  • iPSP support

Studies Supported

  • Blood/protein binding
  • In vitro screening
  • SAD/MAD
  • ADME
  • DDI
  • Renal/hepatic impairment
  • Intrinsic and extrinsic factors (age, sex, ethnicity)
  • Ethnobridge
  • Linearity and dose proportionality
  • Food Effect
  • Pivotal Bioavailability/Bioequivalence
  • High-precision QTc

Clinical Pharmacology Regulatory Expertise and Pharmacometrics Model-Informed Drug Development (MIDD)

Clinical Pharmacology Regulatory Expertise and Pharmacometrics Model-Informed Drug Development (MIDD)

  • Leveraging nonclinical data for human predictive exposures for dose selection in FIH (First In Human)
  • PK/PD modeling and simulation
  • Population PK/PD
  • Quantitative clinical drug development
  • Noncompartmental analysis and reporting
  • Exposure Response analysis
  • Clinical Pharmacology protocols and study reports
  • Dose-finding and justification
  • Intrinsic/extrinsic factors meta-analysis
  • iPSP support

Clinical Pharmacology Regulatory Expertise and Pharmacometrics Model-Informed Drug Development (MIDD)

  • Leveraging nonclinical data for human predictive exposures for dose selection in FIH (First In Human)
  • PK/PD modeling and simulation
  • Population PK/PD
  • Quantitative clinical drug development
  • Noncompartmental analysis and reporting
  • Exposure Response analysis
  • Clinical Pharmacology protocols and study reports
  • Dose-finding and justification
  • Intrinsic/extrinsic factors meta-analysis
  • iPSP support