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Top 10 Global Clinical Research Organizations in 2021| Medicilon Pharmacokinetic Services for First-in-Class Ubiquitination Inhibitor Development| ADC, precision and deep cultivation for targeted drug delivery
Sep 28,2021
Bioavailability of Different Dosage Forms of Glimepiride
Glimepiride belongs to the third generation of sulfonylureas and is widely used clinically in the treatment of type 2 diabetes. Tablets and pills are common dosage forms of glimepiride. Using in vitro dissolution tests to determine the bioavailability of glimepiride tablets and dropping pills can evaluate the quality of glimepiride in different dosage forms producedRead more
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Bioavailability of Different Dosage Forms of Glimepiride
Sep 27,2021
The Effect of Particle Size on Drug Bioavailability
Controlling the particle size of a drug is a key part of drug preparation. The size of the drug particle size can directly affect the solubility and dissolution rate of the drug, thereby affecting the clinical efficacy. For example, in the development of solid preparations, reducing the particle size of drug particles can significantly increaseRead more
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Sep 26,2021
What is Pre-IND Meeting FDA?
Before the sponsor submits the IND application, the sponsor can request a Pre-IND meeting FDA with the review leader. The main purpose of the meeting is to evaluate and reach consensus on the design of animal research needed to support the first human trial, which can speed up the development of new drugs, effectively shorten.
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What is Pre-IND Meeting FDA?
Sep 26,2021
The United States Exempts the IND's BA/BE Safety Report Requirements
BA/BE Exempted From IND Requirements Not all BA/BEs meet the requirements of IND exemption (that is, there is no need to submit an IND application and perform clinical trials in accordance with IND requirements). For example, BA/BE involving cytotoxic drugs does not meet the requirements of IND exemption. The guidelines followed by the US INDRead more
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The United States Exempts the IND's BA/BE Safety Report Requirements
Sep 24,2021
Acute Toxicity Test/Detection/Evaluation
Acute Toxicity Test / Repeated Dosing Screening Test Acute toxicity evaluation is one of the basic types of in vivo safety evaluation. Drug registration often requires acute toxicity evaluation. Acute toxicity test data has a special role in safety evaluation, and MTD or MFD can be determined in the initial toxicity description. The data obtainedRead more
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Acute Toxicity Test/Detection/Evaluation
Sep 23,2021
Medicilon-Your Ideal DMPK Research Partner
The research and development of innovative drugs is a long-term process with high investment, high risk and high return. It takes more than ten years on average from early discovery to successful listing, and the cost is as high as more than 1 billion US dollars. Pharmacokinetics (DMPK) research runs through all stages of leadRead more
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Medicilon-Your Ideal DMPK Research Partner
Sep 23,2021
Common ELISA Format
The competitive ELISA format is based on the binding competition in the initial insulin RIA and IgG EIA methods. The competition between the target analyte from the sample and the reference analyte and the binding of the analyte-specific antibody is the key to this format. Either antibody or target analyte can be labeled with enzymeRead more
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Common ELISA Format
Sep 22,2021
Direct vs Indirect Elisa
All you need to know about the ELISA experiment is here. ELISA, the full name of enzyme-linked immunosorbent assay, is a commonly used immunoassay method; Detection Principle The known antigen or antibody is adsorbed on the surface of the solid phase carrier, the antigen or antibody is labeled with enzyme, and the antigen or antibodyRead more
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Direct vs Indirect Elisa
Sep 22,2021
Development History and Market Prospects of Bispecific Antibodies
With the development and progress of antibody technology, the research and development of bispecific antibodies has shown a good development prospect, which is expected to fill the shortcomings of current therapies in some indications. Recently, Medicilon assisted Biotech's first bispecific antibody (PD-L1/CD47). ) Apply for clinical application. With the development of bi-antibody technology, bi-antibody nowRead more
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Sep 18,2021
New Drug Preclinical Trials
"Administrative Measures for Drug Registration" (Bureau Order No. 28) for pre-clinical provisions Article 21 Pre-clinical trail of drugs for the purpose of applying for drug registration, including drug synthesis technology, extraction methods, physical and chemical properties and purity, dosage form selection, prescription screening, preparation technology, inspection methods, quality indicators, stability, pharmacology , Toxicology, Animal pharmacokineticsRead more
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New Drug Preclinical Trials