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FAQs

FAQs
What are Advantages of Peptides?
Advantages and Features Significant activity, strong specificity, good affinity with receptors, weak toxicity, generally not easy to accumulate in the body.
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Where do Polypeptides Come From?
•Natural extract peptide: such as bone peptides •Chemical synthesis: exenatide, natriuretic peptide, Bremelanotide (2019.6), Afanotide (2019), etc.
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What are Polypeptides?
Chemical synthesis, larger than 40 amino acids but less than 100 amino acids (FDA, FDA-2018-N-2732, 2018) Peptides generally refer to a class of compounds formed by dehydration and condensation of 3-50 A-amino acids.
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What is New Drug Development for Diabetes?
Ultra-short-acting insulin,Short-acting insulin ,Intermediate-acting insulin,Long-acting insulin
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What is a JAK inhibitor?
Small molecule drugs targeting JAKs. Various small molecule inhibitors have been developed for autoimmune diseases. Based on their selectivity and different targets, they can be divided into non-selective, selective, and compound categories.
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What are PK Characteristics of Monoclonal Antibodies and Small Molecule Drugs?
Traditional small molecule drugs:Tissue penetration: Usually very good;Binding: usually contains distributions;Degradation: Metabolic degradation;Renal elimination: Usually very important , and so on.
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What is in vivo PK Study?
BA method development + PK pre-experiment + BA method validation Determine a reasonable calibration range, examine the interference and stability in the actual sample, and optimize the blood sampling time point (3 points near tmax at least; time points in the absorption phase, ast3 *t/2 or Clast 1/10 Cmax)
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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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What are Features of Ideal DMPK?
•Complete absorption (passive absorption is better), bioavailability > 50% and small variation; •AUC is proportional to dose, and PK/PD correlation is clear;
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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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