Pre-Clinical and Clinical Analytical Testing

Pre-Clinical and Clinical Analytical Testing
Product Description

ARL Bio Pharma has extensive experience with chemical, manufacturing and controls testing for original and abbreviated new drug applications. This testing includes: identification tests, quantitative tests for impurities content, limit tests for the control of impurities, performance tests such as dissolution/disintegration and quantitative tests of the active moiety in samples of drug substance or drug product or other selected component(s) in the drug product. 

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ARL Bio Pharma

  • US
  • 2019
    On CPHI since
  • 3
    Certificates
  • 100 - 249
    Employees
Company types
Contract Service
View company profile
Categories
more categories Show less

ARL Bio Pharma

  • US
  • 2019
    On CPHI since
  • 3
    Certificates
  • 100 - 249
    Employees
Company types
Contract Service
View company profile

More Products from ARL Bio Pharma (14)

  • Dissolution Testing

    Product Dissolution Testing

    Quality tests to ensure proper performance of the formulation, generally solid oral dose forms such as tablets and capsules.
  • E. Coli Host Cell Proteins

    Product E. Coli Host Cell Proteins

    ELISA methods are used to test for the presence of residual host cell proteins left in a drug or therapeutic protein following purification. 
  • Extractable Volume

    Product Extractable Volume

    Each container of an injection contains sufficient excess to allow withdrawal of the labeled quantity of drug.  This test allows measurement to verify withdrawal and administration of the labeled volumes.
  • Osmolality

    Product Osmolality

    Osmolality measures the concentration of a solution expressed as the total number of solute particles per kilogram of water.  The units of osmolality are osmole per kilogram of water (Osmol/kg) or milliosmole per kilogram of water (mOsmol/kg).
  • Osmolarity

    Product Osmolarity

    Osmolarity is a theoretical quantity that is calculated from the experimentally measured value of osmolality and the density of the solution. The units of osmolarity are osmole per liter of solution (Osmol/L) or milliosmole per liter of solution (mOsmol/L).
  • PK/PD Studies

    Product PK/PD Studies

    A PK/PD study analyzes the rate and extent of absorption of the active ingredient or moiety and emphasizes the use of pharmacokinetic endpoints in an accessible biological matrix, such as blood, plasma, and/or serum, to indicate release of the drug substance from the drug product into the systemic circulat...
  • Protein Aggregation

    Product Protein Aggregation

    This test detects and quantifies impurity particles in a drug or therapeutic protein.
  • Protein Content

    Product Protein Content

    This test quantitates the total protein in pharmaceutical drug or therapeutic protein and products.
  • Raw Material Testing

    Product Raw Material Testing

    ARL Bio Pharma qualifies drug substances, excipients, and drug products to meet pharmacopeia specifications.

    USP / NF (United States Pharmacopeia) testingEP (European Pharmacopeia) testing
    JP (Japanese Pharmacopeia) testing

    ...
  • Residual Protein A

    Product Residual Protein A

    ELISA methods are used to test for the presence of residual proteins left in a drug or therapeutic protein following purification.
  • Stability Studies

    Product Stability Studies

    A stability study measures the extent to which a product retains, within specified limits, and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of compounding.

    A study commonly includes: a stability indicating method assay, sterility...
  • Biological Activity

    Product Biological Activity

    This test provides a direct measure of the effectiveness of the active ingredient.
show all 14 other products