A clinical trial default approval is a system where applicants can proceed with drug trials as planned if the review agency does not reject or question the submission within a set period.

A rare disease, also known as an "orphan disease," refers to diseases with relatively low prevalence rates.

Triple-Negative Breast Cancer (TNBC) is a subtype of breast cancer that lacks estrogen receptors (ER), progesterone receptors (PR), and human epidermal growth factor receptor 2 (HER-2) on its cells.

BCVA stands for Best Corrected Visual Acuity, which is a key indicator commonly used in ophthalmic clinical trials to evaluate a patient's visual acuity.

The Therapeutic Index (TI) is an important parameter in assessing the safety of drugs. It is used to measure the relationship between the safety and effectiveness of a drug.

LD50 (median lethal dose) is a commonly used indicator in toxicology to describe the toxicity of toxic substances or radiation.

ED50 (Effective Dose 50) refers to the dose of a drug or substance that produces a desired effect in 50% of a population or sample under a given set of experimental conditions or in a group of test subjects.

Radioactive therapeutic drugs, also known as radioactive drugs, mainly function based on the particles or rays produced by the radioactive decay of radionuclides.

The storage method for radioactive drugs needs to follow specific safety and protection standards to ensure the safety and effectiveness of radioactive substances.

Commonly used radioactive isotopes include 125I and 131I, which can undergo iodination reactions with the tyrosine residues in the antibody.

In the design process of shRNA (short hairpin RNA), the fragment length is an important consideration factor, as it can affect the efficiency and specificity of RNA interference (RNAi).

Interchangeability in biosimilars means they match the original biological drug in quality, safety, and effectiveness, producing identical clinical outcomes.