Clinical Pharmacology Services

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PPD's CLINICAL PHARMACOLOGY SERVICES:

Our dedicated clinical pharmacology team analyzes, presents, and interprets PK/PD data to support your study and make informed decisions during the drug development process.

With over 40 pharmacokineticists and SAS programmers with backgrounds in drug discovery, bioanalysis, pharmacology, toxicology, etc. PPD's clinical pharmacology services will provide detailed PK/PD consultancy from pre-clinical proof of concept studies through all phases of clinical trials.

OUR EXPERTISE:

Clinical Pharmacology/PK Studies

Single ascending dose (SAD)
Multiple ascending dose (MAD)
Bioequivalence (BE)
Bioavailability (BA)
Biosimilar
Food effect (FE)
Drug-drug interaction (DDI)
Radiolabeled ADME
Special populations: Renal impairment, hepatic impairment
Nonclinical PK and toxicokinetics (TK)

PK/PD Analysis

PK input to statistical analysis plan (SAP)
Generation of PK/PD datasets and tables, listings, and figures (TLF's)
PK/PD data interpretation and report writing

We offer clinical pharmacology expertise as part of an integrated drug development program or as a discrete stand-alone service

We also have a range of consulting services that includes:

Gap analysis
Allometric scaling
Clinical development planning and protocol design
Regulatory strategy and regulatory document preparation and submission