Shanghai Medicilon Inc.

On April 20, Medicilon Preclinical Research (Shanghai) LLC (MPR), a wholly-owned subsidiary of Shanghai Medicilon Inc. (Medicilon), has obtained the GLP (Good Laboratory Practice) certification of the National Medical Products Administration (NMPA) for the newly added facilities at Nanhui Park.  In addition, Medicilon obtained two GLP certification approvals for the reproductive toxicity test (Stage III) and the carcinogenicity test qualification.  Medicilon also passed the three-year regular review of NMPA drug GLP. As of now, the service area of MPR GLP services has been increased from 8 to 9, which are single and multiple dose toxicity studies (rodent), single and multiple dose toxicity studies (non-rodent), reproductive toxicity test (Stage I, II, III), genetic toxicity test (Ames, micronucleus, chromosomal aberration), local toxicity test, immunogenicity test, safety pharmacology test, toxicokinetic test, and carcinogenicity test.  The total GLP laboratory area of Me...

 To assess toxicity, Medicilon offers a wide range of GLP and non-GLP toxicology services . GLP and non-GLP Toxicology studies are required to determine the adverse effects of drug candidates and the effect of dosage on toxicity. Preclinical CRO / Toxicology Studies Include: Late-Stage Discovery Studies Pharmacokinetics Study (PK) Maximum Tolerated Dose Studies (MTD) Dose Range Finding Study hERG - Ion Channel Screening Exploratory Toxicology Study (7-day non-GLP Studies with PK) GLP Toxicology Studies 7-day Repeat Dose Study (GLP) 14-day Repeat Dose Study (GLP) 21-day Repeat Dose Study (GLP)   3-month Chronic Repeat Dose Study (GLP) 6-month Chronic Repeat Dose Study (GLP) 9-month Chronic Repeat Dose Study (GLP) Carcinogenicity Studies (Transgenic & 2 year) Safety Pharmacology Studies (GLP) Cardiovascular Study (Telemetry or Piggy-backed) Respiratory Study Central Nervous System Study (CNS Study) Genetic Toxicology (Genetox) Ames Assay (non-G...