Contact Us marketing@medicilon.com
CN
×
Close Button

FAQs

FAQs
Advantages of the PDX Model
No in vitro culture process is required to "screen" tumors
Learn more
What is a PDX Mouse Model?
The PDX model, also as known as the patient-derived tumor xenograft (PDX) model, is constructed by directly transplanting tumor tissue from a patient into a severely immunodeficient mouse and allowing the tumor tissue to grow within the mouse.
Learn more
Factors Limiting Oral Bioavailability
Chemical stability Solubility/dissolution Instability in the GI tract Permeability of the intestinal tract Secretory transport Small intestinal metabolism First-pass hepatic extraction
Learn more
Bioavailability Definition
Oral bioavailability (F) refers to the fraction or percentage of the oral dose that enters systemic circulation intact, the fraction absorbed by the intestinal epithelium (FAbs), the fraction escaping intestinal metabolism and entering the portal vein (FG), and the fraction escaping first-pass hepatic extraction and entering systemic circulation.
Learn more
What are Process Research Methods?
DOE and Parallel reaction; Destructive test (Stress test) ;The Spiking experiments ;
Learn more
What is Process Development Stage?
Process development stage: 1. Literature research, patent evaluation report. 2. Select a synthesis route and design reactions 3. Process optimization. 4. Impurity spectrum study. 5. Analysis of the reaction mechanisms.
Learn more
To What Extent does Process Optimization Need to be Done?
It needs to meet the quality requirements of laboratory scale, safety, pilot, and clinical batches, with appropriate attention to yield and process fluency.
Learn more
How to Control Impurities in Pharmaceutical? To What Extent are Impurities Controlled?
Laboratory scale batch: purity 98.0%, with no significant impact on the limit of any single impurity
Learn more
What are API Quality Study Processes in the IND Phase?
1) Development of analytical method (starting materials, intermediates, API, Middle controlled Analysis, preliminary degradation tests)
Learn more
What are the Steps of API Process R&D in the IND Stage?
Determination of synthesis route; Optimization of process parameter, studies of salt structure and crystal structure process, preparation and calibration of the reference product;
Learn more