A survey of international guidelines for bioequivalence of systemically available orally administered generic drug products / 中国药学杂志

OBJECTIVE: To investigate similarities and differences among bioequivalence approaches used by international regulatory authorities when reviewing applications for marketing new generic drug products which are systemically active and intended for oral administration. METHODS: The comparisons of these bioequivalence recommendations were performed and based on bioequivalence study designs, selection of bioequivalence subjects,dosage, selection of reference products, method of pharmacokinetic calculations and bioequivalence acceptance limits, bioequivalence waiver on multiple-strength products and and implementation of the Biopharmaceutics Classification System, which are issued by Australia, the European Medicines Association, Japan,the USA, and the World Health Organization. RESULTS: There were lots of differences were found in bioequivalence approaches among the regulatory authorities surveyed, although there are more similarities. CONCLUSION: Discussion of the similarities and differences among bioequivalence approaches used by international regulatory authorities would provide instructive and practical assists to the equivalence assessment of quality and curative effect for generic products in China.

Construction and application of a yeast expression system for thymosin a1

We want to construct a yeast expression system for thymosin a1 (Ta1) to make the orally administered Ta1 preparation possible. The whole Ta1 DNA fragment was obtained by PCR. After being digested with restriction enzymes, it was cloned into pYES2 vector. Sequencing was performed to identify the recombinant. The sequence of Ta1 in recombinant coincided with the original one reported in Genbank. When pYES2-Ta1 plasmid was transformed into yeast, galactose instead of glucose was used to induce Ta1 expression. Western blot was performed to identify the quality of the expressed Ta1. Dried yeast containing pYEST2-Ta1 was fed to Balb/c mice whose immunities were inhibited by cyclophosphamide in advance. Synthesized Ta1 peptide was used as positive control and empty yeast was used as negative control. Compared with the negative control group, both dried yeast containing pYEST2-Ta1 and synthesized Ta1 peptide can significantly increase the CD8+ level (22.74±1.09 and 18.77±4.72 vs 7.49±2.14, p<0.01), while both of them had little effect on the CD4+ lymphocytes (61.86±6.94 and 65.91±4.78 vs 57.93±10.40, p>0.05). We concluded that a high effective yeast expression system for Ta1 was constructed successfully and the Ta1 protein expressed by this system can improve CD8+ level in immune inhibited mice.

Construction and Application of Database of“The Time And Age Limit in the Use of Common Orally Ad-ministered Drugs” / 中国药房

OBJECTIVE:To construct the database of“The Time and Age Limit in the Use of Common Orally Adminis-tered Drugs”in order to guide the rational drug use in patients.METHODS:The frequently used instructions of common orally administered drugs in the hospital where the authors worked were collected,and then were classified and listed according to the elements in“The Time and Age Limit in the Use of Common Orally Administered Drugs”,and further summarized according to the basic knowledge in drug administration.RESULTS:Ante cibum drugs accounted for22.2%,post cibum drugs11.7%,either ante cibum or post cibumor or unmarked drugs59.4%,bedtime drugs6.7%,wholly swallowed drugs12.2%,chewed drugs1.7%,children restricted drugs32.2%,and the drugs taken once daily with the set time accounted for13.9%.CONCL_ USION:The construction of“The Time and Age Limit in the Use of Common Orally Administered Drugs”database can guide patients to use medicine rationally.