PK studies in healthy volunteers: we can work with as many as 200 volunteers per study.
Types of dosage forms:
– oral tablets
– ODTs, lozenges and drugs with sub-lingual administration
– syrups and suspensions for oral administration
– sc, im and iv injections
– creams, ointments and lotions
– suppositories
– inhalational substances
– transdermal systems (patches and plasters)
PK/PD studies on healthy volunteers and also on selected populations, such as: patients with asthma (inhalers based on PK studies) or with COPD, patients with neurological, gynaecologic, oncology, dermatology diseases or with conditions treated by internal medicine, postmenopausal women, women with a hormonal imbalance or other endocrine diseases, elderly patients, overweight patients, patients with hypercholesterolemia or dyslipidemia
PK and tolerance studies in dermatology; studies with locally acting products (e.g. Orlistat); Phase I-IV clinical trials
PK Studies:
– drug interactions
– dose finding
– age & gender
– special populations (hepatic or renal failure)
– first-in-man
– bioavailability
– bioequivalence