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Preclinical Pharmaceutical Capabilities

From formulation and method development to bioanalysis, toxicological, and metabolism studies – our experts at Symbiotic Research cover your requirements for preclinical drug development.

Current Capabilities:
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+1 973 426 99 00

Process and Formulation Analysis*

  • Process and Formu­la­tion Analyt­ical Methods Development
  • Drug Substance HPLC Purity Profiling, Stability Indi­cating Method Development
  • Method Vali­da­tion under GLP per FDA-CDER and ICH Regu­la­tions and Guidelines
  • QA Phase Inspec­tions and Data Review
  • DS and Drug Product (DP) Impu­rity Iden­ti­fi­ca­tion and Characterization
  • Stability Studies for DS/API (12 – 24M)
  • Drug Substance (DS) and Drug Product (DP) Impu­rity Iden­ti­fi­ca­tion and Characterization
  • GC Residual Solvent Analysis
  • Issuance of Certifi­cate of Analysis (COA)
  • DP HPLC Purity Profiling, Stability Indi­cating and Assay Method Development

Bioanalysis Studies*

  • LC/MS and CE/MS method development
  • Method vali­da­tion for drugs/​metabolites per FDA or ICH
  • Quan­ti­ta­tive bioanalysis of preclin­ical and early clin­ical samples
  • COA and recer­ti­fi­ca­tion for test substances, refer­ence and metabo­lite standards
  • Metabo­lite profiling for cold and C‑14 labeled compounds, ID and characterization
  • Metabo­lite isolation/​enrichment by frac­tion collec­tion, prep and/​or semi-prep columns
  • Quan­ti­ta­tion of test article and metabolites
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Metabolism Studies*

  • in-vivo analyt­ical ADME services and in-life phase through a part­nering company
  • in-vivo study types include mass balance, tissue distri­b­u­tion, metabo­lite profiling / radio profiling and ID, discovery PK, formu­la­tion bioavail­ability screening and cassette PK
  • in-vitro metab­o­lism studies with pooled liver micro­somes, hepa­to­cytes and S9 fraction
  • Inter­species compar­isons in mouse, rat, dog, rabbit, pig, monkey and human
  • P450 isozyme phenotyping

Other Services*

  • Non-Clin­ical Phar­ma­co­log­ical and Toxi­co­log­ical studies
  • Dissolved O2 Analysis in DP
  • Large-scale Synthesis Support at Manu­fac­turing Sites
  • Devel­oping DS and DP Specifications
  • Product Chem­istry (i.e. physical/​chemical chrac­ter­i­za­tion, storage stability analysis, etc.)

Pharmaceutical aNDA Capabilities for Oncological Agents*

  • USP methods Transfer and Validation
  • Formu­la­tions Development
  • Formu­la­tion Stability Studies
  • Spec­i­fi­ca­tion
  • Drug Substance and Drug Product Manu­fac­turing Support

Note*:

All GC related analysis are outsourced to other Tentamus GLP labs.

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