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FAQs

FAQs
To what extent should PGI study be conducted?
During the later stages of process optimization, impurities in typical samples are systematically analyzed. If they exceed the identification threshold and are speculated and confirmed as PGI, a purification study is required, and limits are controlled according to ICH M7.
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What are the Main Factors that Affect the Speed of R&D?
Long lead time for salt structure screening and crystal structure screening. Insufficient depth in the development and optimization of analytical methods, resulting in repeated efforts.
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What are Gene Therapy Products?
Gene therapy products include nucleic acids (plasmids, RNA) that function through transcription or translation of transmissible genetic material, gene-modified microorganisms (viruses, bacteria, fungi) expressing specific genes, in vitro gene-modified human cells, products that edit the host genome etc.
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Demonstration Method for Control Limits of Organic Impurity
•Scientific literature and main metabolite method: If the scientific literature has proved that a certain level of an impurity poses no safety concern, then the limit based on that level does not require further justification.
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What is the Main Difference Between siRNA and ASO?
The chemical structure,ASO is single-stranded, and siRNA is double-stranded.ASO either degrades target mRNA through RNase H, interferes mRNA function with steric effects or affects mRNA shearing, or acts on miRNA.siRNA degrades mRNA mainly through RISC.
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What are the Types of Nucleic Acid Drugs?
There are various types of DNA and RNA drugs, including antisense oligonucleotides (ASO), small interfering RNAs (siRNA), microRNAs (miRNA), short hairpin RNAs (shRNA), messenger RNAs (mRNA), plasmid DNAs (pDNA), RNA aptamers, and guide RNAs for gene-editing tools like CRISPR.
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Advantages of PROTACS
1. Target undruggable targets •Target transcription factors •Target scaffolding proteins 2. Eliminate pathogenic proteins 3. Ease of developing compounds with high potency/selectivity 4. Potential to overcome drug resistance in cancer therapy
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What is a Cerebral Stroke?
"Cerebral stroke," also known as "stroke" or "cerebrovascular accident," is an acute cerebrovascular disease caused by the sudden rupture or blockage of blood vessels in the brain. This condition prevents blood flow to the brain, leading to brain tissue damage.
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When to Choose a Metastable Crystal Structure for Development?
The solubility and bioavailability of stable crystals are too low;A fast-release agent with a high dissolution rate is required.Polycrystalline forms will also have different mechanical properties, such as hardness, powder fluidity, compressibility, and bonding strength.
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Why Choose a Thermodynamically Stable Crystal Form for Development?
Without the influence of solvent and humidity, a polymorph that is thermodynamically stable at room temperature is the only form guaranteed to not convert to another polymorph.
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