Examples of test articles are drug substance (DS), drug product (DP), placebo, matrices (e.g., formulation buffer, biological fluids), active pharmaceutical ingredient, excipient, impurity, etc. The assay category is defined per the ...
Examples of test articles are drug substance (DS), drug product (DP), placebo, matrices (e.g., formulation buffer, biological fluids), active pharmaceutical ingredient, excipient, impurity, etc. The assay category is defined per the International Council for Harmonisation of Technical Requirements f...
The dissolution characteristics of the drug product should be developed based on consideration of the pH solubility profile and pKa of the drug substance. The selection of a suitable dissolution medium (composition, volume) should be based on the...
Drug Substance Process Development Bioreactor development including batch versus fed batch High-throughput protein purification process development Non-GMP and GMP Pilot (200L / 500L) manufacture capacities Stability on drug substance Drug Product Development ...
Degradation of the active drug substance induced by a chemical entity leached from a packaging component Reduction in the concentration of an excipient due to absorption Adsorption or leachable-induced degradation Changes in drug product pH Discoloration of either the dosage form or the packaging compone...
Single versus multiple drug focus in substance abuse clinical trials research. Drug Alcohol Depend. 70, 117-125.Rounsaville BJ, Petry NM, Carroll KM. Single versus multiple drug focus in substance abuse clinical trials research. Drug Alcohol Depend. 2003;70(2):117-25....
When the solubility of substances in aqueous media is limited, formulation strategies are required early on in the drug discovery and they remain of critical importance for lead substance selection and commercial drug product development. The major drug solubilization strategies are summarized in Table ...
40.Watson, J, Greenough, EB, Leet, JE, Ford, MJ, Drexler, DM, Belcastro, JV, Herbst, JJ, Chatterjee, M & Banks, M (2009). Extraction, identification, and functional characterization of a bioactive substance from automated compound-handling plastic tips.Journal of Biomolecular Screening, Vol...
Endogenous substanceDiseases involvedRelated nuclear receptor or protein Glucose and lipid • Obesity and type 2 diabetes232 • PXR, CAR Biliary bile acid • Cholesterol gallstone233,234 • Cholestatic syndrome235 • PXR, FXR • P53 Corticosterone and aldosterone • Steroid dyshomeostasis234...
The drug can be either conjugated on the surface of the magnetic substance or encapsulated into a sphere, in a targeted magnetical drug delivery system. The effectiveness of magnetic carrier applications, depends on numerous factors like the size of particles, the surface characterization, the ...