Phase I: PK/PD, First-in-Man
PROMETRIKA statisticians have extensive experience in conducting complete analyses for pharmacokinetic and pharmacodynamic studies (PK/PD), including statistical analyses of PK and PD parameters.
Some of our clients provide patient PK and PD parameters for each patient and request that we conduct statistical analyses, while others provide the plasma and urine concentration data, and request that we calculate the PK and PD parameters using WinNonlin® and/or our own SAS® programs. We have also written customized programs for performing PK/PD modeling and evaluating dose-proportionality. Our medical writing staff has significant experience in writing stand-alone PK/PD reports as well as integrated clinical study reports, including PK/PD sections.
We work with clients’ PK/PD departments or consultants retained by the client who provide input during analyses and in writing the clinical study report. PROMETRIKA may also retain a PK/PD consultant to obtain that input, if a sponsor has neither their own internal department nor consultants. Below is a sampling of PK/PD studies we have completed or are currently conducting:
- Three studies for a systemic medication for psoriasis
- Three studies for an oral asthma treatment
- Four studies for three separate oncology drugs
- One study for a topical treatment for eczema
- Four studies for nasal steroids for allergic rhinitis
- Four studies for an inhaled treatment of Chronic Obstructive Pulmonary Disease (COPD)
- One study for seasonal and perennial allergic rhinitis
- Two studies for an immunological indication
- One study for a topical treatment of atopic dermatitis