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Clinical Pharmacology Unit |
 | CLINICAL PHARMACOLOGY UNIT
designs Phase I clinical trials in healthy volunteers and follows their carrying out producing final reports for application purposes in compliance with GCP/ICH requirements. More than 500 trials allowed I.P.A.S. to gain a deep experience, working with European, Asiatic and American sponsors. In addition to bioequivalence trials, the experience of I.P.A.S. covers bioavailability, pharmacokinetics, interaction, metabolism, excretion and ADME of hundreds of drugs.
PROFESSIONAL STRENGHT
• A staff of full time pharmacokineticists
• Full time internal physicians and external specialized consultants
• Internal monitors and QA services
| | | FACILITIES
• 36 beds
• a file of 1500 healthy male and female healthy volunteers
• internal kitchen for normal and special dietary regimens
• internal radiology
• computerized telemetry to ensure constant ECG monitoring
• spirometry equipment
|  | ETHICS
Study protocols are submitted monthly to the Ethics Committee of Canton Ticino and, when approved, are notified to the Central Federal Authority (Swissmedic). The study is authorized to start one month later.
SERVICES
Thanks to the qualified staff and to the highly specialized facilities of the clinic, I.P.A.S. is able to conduct approximately 50 pivotal trials per year. GCP and internal SOPs are closely monitored by internal Monitors and checked by QA. All procedures, from the study design to the reporting and archiving, are carried out in the same building. Hundreds of publications support the extensive experience in pharmacokinetics of I.P.A.S. scientists. |
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Clinical Pharmacology Unit