Pharmaceuticals - Test Request 19-00484

Pharmaceuticals Test Request

Request: 19-00484

Status: Lab Needed

Closes: 05/14/2019

Title:

FDA GLP Chronic safety studies

Description:

Pharmaceutical Preclinical Contract Research Organization neeeded for FDA GLP Chronic safety studies of a drug/device product for leg ulcers. Product is currently in clinical trials in Europe, and company is interested in developing product for U.S. market. Since results would be submitted to FDA, testing must be done under GLP.

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Drug Discovery Testing

Drug Development Testing

Non-Clinical Study Testing

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Clinical Trials Testing

Pharmacokinetics (PK) Testing

Pharmacodynamics (PD) Testing

ADME Testing

Sterility Testing

Pyrogens Testing

Endotoxins Testing

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Finished Product Quality Control Release Testing

Real-Time Stability Testing

Accelerated Stability Testing

Method Development Testing

Method Validation Testing

Drug Release/Dissolution Testing

Extractable Testing

Leachable Testing

Elemental Impurities Testing

Packaging Testing

Child-Resistant Packaging Testing

Container Closure Integrity Testing (CCIT) Testing

High Throughput Screening Testing

Reverse Pharmacology Testing

Excipients Testing

Active Pharmaceutical Ingredient API Testing

Toxicology Testing

Toxicity Testing

Microbiology Testing

Strength Testing

Quality Testing

Purity Testing

Consistency Testing

Acid Insolubles Testing

Acid Solubles Testing

Alkali Solubles Testing

Alkalinity Testing

Appearance Testing

Boiling Point Testing

Congealing Temperature Testing

Flash Point Testing

Melting Point Testing

Freezing Point Testing

Hardness Testing

Heat of Combustion Testing

Preservatives Testing

Loss on Drying (under Vacuum) Testing

Loss on Ignition Testing

Melting Point Testing

Mineral Analysis Testing

Non-aqueous Titration Testing

Normality Testing

Organic Acids Testing

Organic Extractives Testing

Oxidizing Substances Testing

Peroxide Value Testing

Pour Point Testing

Reactivity Testing

Reactivity to Water Testing

Reducing Substances Testing

Refractive Index Testing

Residue on Evaporation Testing

Residue on Ignition Testing

Saponification Value Testing

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Silver Reducing Substances Testing

Silicon Testing

Sulfur Testing

Sodium Testing

Specific Gravity Testing

Specific Rotation Testing

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Surfactants Testing

Talc Testing

Titration Curve Testing

Total Halides Testing

Total Reducing Compounds Testing

Unburned Carbon Testing

Uncarbonized Constituents Testing

Unsaponifiable Matter Testing

UV Absorption Testing

Volatile Matter Testing

Volatile Suspended Solids Testing

Weight Variation Testing

Cytotoxicity Testing

Elution Testing

Agar Diffusion Testing

Bioburden Testing

Antimicrobial Effectiveness Testing

Particulates Testing

Total Combined Mold & Yeast (TYMC) Testing

Total Aerobic Microbial Count (TAMC) Testing

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