Bioequivalence (BE) means that under the same experimental conditions, different preparations of a drug are given the same dose, and the main pharmacokinetic parameters of its absorption rate and degree are not statistically different. When the difference of absorption speed is not significant in clinic, some pharmaceutical preparations can be considered as bioequivalent under the condition of the same absorption degree but different speeds. Bioequivalence is different from drug equivalent, which means that the same dosage of the same drug is made into the same dosage form, but the inactive ingredients are not necessarily the same, and the content, purity, uniformity, disintegration time limit and dissolution rate meet the same prescribed standards. Drug equivalence can not reflect the situation of drug preparation in vivo.
supplement
Study the commonly used analytical methods
Chromatography: Used for the detection of most drugs.
Immunoassay: It is mostly used to detect polypeptides in protein.
Microbiological methods: It can be used to determine antibiotics.
experimental procedure
1. experimental design and operation
1。 cross-over design
2。 Theme selection
3。 Dosage of administration
4。 sample
5。 Parameter calculation.
6。 standardization
Data processing and statistical analysis
1。 Data expression
2。 Pharmacokinetic parameters
3。 statistical analysis
Evaluation of results.