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FAQs
Types of Early DMPK Studies
Protein binding: plasma, brain tissue, microsomal protein, FBS; Erythrocyte /plasma partition ratio ​Optimization permeability and transshipment: Caco - 2. MDCK - MDR1 / BCRP, OATs/OCTs/OATPs
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The Key of Stability Studies in Phase I and Phase III Clinical Trials
Phase I clinical ◆ Stability data should support be able to support the formulation to meet the requirements during the clinical study
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Differencese of Quality Research Between Phase Ⅰ and Ⅲ?
Phase 1 clinical No need for comprehensive and complete validation of analytical methods (need for specificity, sensitivity, etc.)
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Classification Based on the Structural Form of Bispecific Antibodies
IgG-like BsAb has an Fc part and Fc-mediated effect functions, such as antibody-dependent cell-mediated cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and antibody-dependent cell-mediated phagocytosis (ADCP). The Fc part of the antibody is helpful for purification and improves its solubility and stability in the later stages.
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Types of Bispecific Antibodies
According to different structures, bispecific antibody structures can be divided into two main categories: bispecific antibodies with Fc fragment (IgG-like bispecific antibody) and bispecific antibodies without Fc fragment (non-IgG-like bispecific antibody).
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How to Optimize Oral Bioavailability in the Drug Discovery?
1) Understanding the structural boundaries associated with oral absorption 2) Identifying/determining the cause of poor oral bioavailability within a compound family
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Importance of Pilot Scale-up
The pilot scale is generally a production activity where the process exceeds the kilogram level for the first time, and there are various uncertain factors.
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What is Ideal Synthetic Route?
Economic and reasonable • Simple synthesis route with few steps • FDA: The proposed starting material should react multiple steps apart from the final intermediate of the API • The raw materials are easy to obtain and stable. • Intermediates are easily separated and stable. • It is easy to operate and reaches the medicinal standard after separation and purification. • High yield, low cost and maximum economic benefit
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Characteristics of an Excellent API Synthesis Process
Feasibility,Controllability,Rationality
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What is the Goal of Process Development?
The goal of API manufacturing process development is to establish a commercial manufacturing process capable of consistently producing the API of expected quality.
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