Pharmaceutical Preclinical In Vivo Comparison Study
Project Description
USA Pharmaceutical Bioanalytical Laboratory needed for in vivo comparison study to a reference product ? to show comparability between the test and reference product
2. analytical methods developed and validated to quantify analytes in blood/plasma and in tissue will be necessary.
3. The lower limits of quantitation and recovery in plasma, tissues and, where relevant, in particular tissues of interest e.g. see table 1 below, should be stated.
Study endpoints:
Dose finding study (rodents)
? to establish appropriate dose levels which can be accurately measured (sensitivity of the method) and
? to determine the best sampling strategy of time points to reflect the incoming iron and release of iron from the respective tissue.
Project Information
Number:23-02827
Industry:Pharmaceuticals
Other pharmaceuticals laboratory services.
Other Pharmaceuticals testing, analysis, scientific research and development, inspection, certification, engineering, failure investigation, and product development needs include :
- Drug Discovery Testing
- Drug Development Testing
- Non-Clinical Study Testing
- Preclinical Study Testing
- Clinical Trials Testing
- Pharmacokinetics (PK) Testing
- Pharmacodynamics (PD) Testing
- ADME Testing
- Sterility Testing
- Pyrogens Testing
- Endotoxins Testing
- Raw Material Testing
- 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
- Sieve Analysis Testing
- Silver Reducing Substances Testing
- Silicon Testing
- Sulfur Testing
- Sodium Testing
- Specific Gravity Testing
- Specific Rotation Testing
- Sugars Testing
- Sulfur Compounds Testing
- 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
- Testing
