Services

Services

DMPK/Toxicity

DMPK Services

PharmaLegacy offers the clients a broad spectrum of high quality services in the areas of in vitro ADME, in vivo pharmacokinetics and bioanalysis services, with cost-efficiency and fast turnaround. The test articles range from small molecules to large molecules, such as protein and antibody. The animal species involved are non-human primate, canine, mice, rat, rabbit, guinea pig and mini pig. 


  Bioanalysis


            Method Transfer, Development and Validation
           - LC-MS/MS (small molecules, peptides and protein)            

           - ELISA (antibody)
           - HPLC (small molecules and oligonucleotides)
  
 
             Biological Matrix
           - Plasma, serum and blood                                                    

           - Urine, feces and bile
           - Tissues and tumor specimens                                             

           - Cerebrospinal fluid
 

   In Vivo Pharmacokinetics


              In Vivo Dosing
           - Intravenous (bolus/infusion)                                                 

           - Intra-duodenal, intra-portal
           - Oral, subcutaneous, intraperitoneal, intramuscular, dermal plus other routes
  


            Outputs
           - Sample concentrations                                                        

           - PK parameters (WinNonLin)


           Services
           - Bioavailability                                                                       

           - Single and multiple dose PK
           - Crossover studies                                                                

           - Cassette PK for compound screening
           - Dose ranging and proportionality                                         

           - BBB penetration
           - Drug distribution in tissues                                                   

           - Excretion studies
           - PK study for formulation/form development                         

           - Exploratory non-GLP TK studies
           - PK/PD study in animal disease models                               

           - DMPK study for IND filing

  

Toxicology Services

        PharmaLegacy has professional teams with rich experience in toxicology studies. We offer high-quality data and rapid turnaround period to support drug discovery and development. The toxicological studies are conducted in various animal species under non-GLP and/or GLP compliance. 

 

           Single dose toxicity study (rodent and non-rodent)
           - LD50 study
           - MTD study
           - Dose escalation study


            Repeated dose toxicity study (rodent and non-rodent)
           - 7-day and 14-day DRF study
           - 1-month to 9-month sub-chronic and chronic toxicity study


            Immunogenicity study


           Toxicokinetics study (rodent and non-rodent)


          Topical toxicity study
           - Irritation study
           - Sensitization study
           - Hemolysis study