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Top 10 Global CDMO Enterprises| The Meaning of IND, NDA and ANDA| Top 10 Global Clinical Research Organizations in 2021
Oct 22,2021
What is an API Drugs?
What is an API Drugs? API drugs refer to the raw materials used in the production of various preparations. They are the effective ingredients in the preparations. Various powders, crystals, extracts, etc., prepared by chemical synthesis, plant extraction or biotechnology, are used for medicinal purposes. Substances taken directly. APIs, also known as active ingredients ofRead more
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Oct 22,2021
What is the Difference Between Genuine Drugs, Generic Drugs, and APIs?
Genuine Drug-What is a Genuine Drug? Genuine medicine is a concept unique to China, and it is called original research drug in European and American countries. It refers to the original research and development of new drugs, which have been approved for listing after tens of thousands of compounds and rigorous clinical trials. It takesRead more
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Oct 21,2021
Development and Verification of Analysis Methods for Disposable Systems
The dissolution/precipitate evaluation is an important part of the process-specific verification of filters and disposable systems in the pharmaceutical field to examine the applicability of equipment (including filters and disposable systems) in specific processes. This article describes the development and validation of the dissolution/precipitate analysis method for the verification test of the dissolution/precipitate, and introducesRead more
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Oct 21,2021
HPLC Analysis Method Development and Verification System
Analytical method development The development of analytical methods mainly includes the selection of chromatographic columns, the selection of mobile phases, the selection of detection wavelengths, and the optimization of gradients. At present, HPLC is mostly used in reversed phase, so this article mainly uses reversed phase as an example to explain. Selection of Column TheRead more
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Oct 21,2021
Summary of the Development and Verification of Analytical Methods for Stability Indicators in New Drug Research
In the Non-Clinical stage of new drug development, why develop methods with stability indicators? What is the difference between the non-Clinical stage degradation test and the later stage? What precautions need to be considered? Have the difficult problems in method validation trouble you for a long time? Drug Non-clinical Research and Stability Indication Method Non-clinicalRead more
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Oct 21,2021
To What Extent can the Calculation of ADMET of Candidate Drugs be Predicted?
The discovery and development of new drugs is expensive & time-consuming! Whether a candidate can become a medicine is a work that R&D personnel continue to explore! When a molecule has obtained the desired drug effect, the work of preparing the drug begins to spread, and the research work of “absorption-distribution-metabolism-excretion-toxicity” (ie ADMET) is alsoRead more
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Oct 21,2021
How a Pill Accomplishes its Mission in the Body-ADME
Drugs enter the body through the four processes of absorption, distribution, metabolism, and excretion, but the four processes of different administration routes have their own advantages. Today we talk about the most common oral drug absorption and metabolism processes in the digestive tract. After oral administration of the drug in the gastrointestinal tract, it entersRead more
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Oct 14,2021
Talking about Pharmacokinetics PK
Pharmacokinetics (pharmacokinetics, PK) and pharmacodynamics (pharmacodynamics, PD), in fact, can be described as key research content, the two complement each other and are indispensable. PK refers to the quantitative study of the changes in the in vivo processes such as absorption (A), distribution (Distribution, D), metabolism (Metabolism, M) and excretion (Excretion, E) of drugs inRead more
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Talking about Pharmacokinetics PK
Oct 14,2021
What are the Procedures for DMPK?
The DMPK study of the new drug in the corresponding patient, including the pharmacokinetic study of a single dose or/and multiple doses; If the new drug is a prodrug or a drug that is mainly eliminated in the human body by metabolism, the metabolic pathway, metabolic structure and pharmacokinetics of the new drug need toRead more
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Oct 14,2021
What are the DMPK Parameters?
DMPK Parameters: Peak drug concentration (Cmax) The highest blood drug concentration after administration. This parameter is an important indicator reflecting the absorption rate and degree of absorption of drugs in the body.Peak time (Tmax)    the time required to reach the peak concentration of the drug after administration. This parameter reflects the rate at which theRead more
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