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FAQs

FAQs
What is a PDX Mouse Model?
​The PDX model, as known as the patient derived tumor xenograft (PDX) model, is a model constructed by directly transplanting tumor tissue from a tumor patient into a severely immunodeficient mouse and making the tumor tissue grow in the mouse.
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Factors Limiting Oral Bioavailability
Chemical stability; Solubility/dissolution; Instability in GI; Permeability of intestinal tract; Secretory transport; Small intestinal metabolism; First-pass hepatic extraction;
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Bioavailability Definition
(FH)F= FAbs•F•FH
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Process Research Methods
DOE and Parallel reaction; Destructive test (Stress test) ;The Spiking experiments ;
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Process Development Stage
Process development stage: 1. Literature research, patent evaluation report. 2. Selection of synthesis route and reaction design. 3. Process optimization. 4. Analysis of the reaction mechanism.
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To What Extent does Process Optimization Need to be Done?
Meet the quality requirements of laboratory scale, safety, pilot, and clinical batches, with appropriate attention to yield and process fluency.
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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 single impurity
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What are API Quality Study Processes in IND Phase?
1) Development of analytical method (starting materials, intermediates, API, Middle controlled Analysis, preliminary degradation tests)
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What are the Steps of API Process R&D in IND Stage?
Determination of synthesis route; Optimization of process parameter, studies of salt structure and crystal structure process, preparation and calibration of reference product;
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What is Stability of a Drug?
Stability of a drug refers to the degree to which the physical, chemical, biological and microbial properties of an active substance or formulation can be maintained within prescribed limits during its entire storage and use.
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