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Study type

San Matteo Phase I Clinical Trial Unit and Experimental Therapy conducts phase I/II studies in healthy volunteers and patients covering a wide range of disciplines including pharmacokinetics, pharmacodynamics and safety evaluation.
 

1. Immunomonitoring studies

a. Assessment of immune responses in human clinical trials

i. Cryopreservation of cells, tissues and cell cultures
ii. Cytometric analysis of surface and intracellular antigens
iii. Analysis of T, B and NK cellular functional activity
iv. Induction and expansion of anti-viral and anti-tumoral long term cellular lines
v. Expansion and phenotypical and functional characterization of mesenchymal stem cells
vi. DNA, RNA and protein extraction
vii. DNA polymorphism analysis (STRs, VNTRs, SNPs)
viii. Gene expression analysis by quantitative PCR
ix. Agarose and polyacrylamide gel electrophoresis
x. Telomerase activity evaluation
 


2. Biopharmaceutic Studies

a. Bioavailability Studies
b. Comparative BA and Bioequivalence Studies



3. Pharmacokinetic Studies using Human Biomaterials

a. Plasma protein binding Studies
b. Hepatic metabolism and Drug interaction Studies


4. Human Pharmacokinetic (PK) Studies

a. Healthy subject PK and initial tolerability studies (First-in-man)
b. Multiple dose tolerability & pharmacokinetics
c. Patient PK and initial tolerability study

 


5. Human Pharmacodynamic studies

a. Healthy subject PK/PD studies
 


6. Efficacy and safety studies

a. Single ascending dose tolerability & pharmacokinetics
b. Local tolerability & sensitization potential
c. QTc prolongation studies
d. Skin irritation/sensitization


 


Data ultimo aggiornamento:  21/12/2011
 

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