Methods

Pharmeteo accumulated experience and methodological considerations informed by years of involvement in regulatory submissions, with an emphasis on how products progress through regulatory review toward patient benefit. 

US Agent Representation &Communication  – Methodological considerations related to U.S. regulatory representation, including the structure of FDA submissions, formal communication pathways with FDA Project Managers, and information flow mechanisms commonly used during regulatory review. 

Gap Analysis – Assessment regulatory interactions, current CMC Information, Nonclinical and Clinical Studies, and assess for additional documentation or needed studies for your therapeutic area submission for a successful application approval.

Health Authority Interaction Considerations– Methodological insights are provided on the role of early gap assessment in informing regulatory strategy, communication planning with health authorities, and preparation for regulatory meetings, based on observed regulatory review practices.

• Regulatory strategy and integrated drug development across all phases, therapeutic areas, and patient populations (including pediatrics)

• Dose justification, candidate selection, first-in-human, proof of concept, dose-ranging safety and efficacy studies, registration, and lifecycle management

• Pre-IND, IND, NDA, and ANDA support

• Interpretation of pre-clinical data as a guide for next steps in clinical pharmacology programs

• Drug-drug interaction (DDI) waiver justifications. In vitro/in vivo transporter and DDI study guidance

• Interpretation of industry guidance documents for individual clinical pharmacology development programs

Pharmeteo accumulated methodological experience in articulating study rationale, design considerations, dose justification, participant population rationale, PK and/or PD sampling strategies, analysis planning, data interpretation, and reporting practices across clinical trial phases.

Clinical Study Strategy and Design Services:

• Clinical pharmacology development strategy

• Study design and protocol development

• Dose rationale and dose administration

• PK and PD sampling schedule

• Inclusion/exclusion criteria

• Robust PK and PD analysis

• Clinical study report (CSR) and/or standalone PK report

• Contribution to Pre-IND, Briefing document, IND/NDA modules’ writing

• IB, Label and Safety update

Clinical Pharmacology Studies Supported:

• First-In-Human (FIH), Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD)

• Proof of Concept and Larger Dose Ranging

• Thorough QT/QTc (TQT), including cQT analysis

• Relative Bioavailability and Pivotal Bioequivalence

• Drug-Drug Interaction (DDI)

• Food Effect

• Large Registrational Safety and Efficacy, to establish population PK and exposure-response (PK/PD)

• Renal Impairment and Hepatic Impairment

• Pediatric and Elderly

• Site of Absorption

• Radio-Labeled Mass Balance

Model-Informed Drug Development (MIDD) is recognized as a decision-support paradigm that can inform clinical development decisions, increase the probability of success in clinical studies, and reduce overall drug development costs. Both the FDA and EMA have acknowledged MIDD as an essential component of drug development programs involving new molecular entities. 

Population Pharmacokinetics (PopPK)

Population pharmacokinetics is used to understand the variability in drug concentrations among individuals in a group of interest . Patient characteristics. Understanding this variability can help establish a robust PK/PD profile and inform safe and effective dosing regimens.

• Model-Informed Drug Development Plan

• Statistical Analysis Plan (SAP) or PK Analysis Plan (PAP) development

• Population PK/PD, Exposure-Response Analysis, dose Selection and Justification

• Concentration QT (cQT) Modeling

Physiologically Based Pharmacokinetics (PBPK)

PBPK modeling is a tool that uses physiologically relevant mathematical descriptions of biological processes to make quantitative PK predictions.

• Physiologically Based Pharmacokinetics (PBPK)

• Drug-drug Intercation (DDI)

• Bioavailability (BA) and bioequivalence (BE)

• First in Human (FIH)

• Food Effect

• Renal Impairment and Hepatic Impairment

• Pediatric and Elderly

Non-compartmental analysis (NCA)