主题：大家对【原研药】怎么看 -- 斯特拉斯堡

1，中国的一致性评价标准，据说是抄美国的。

2，这个标准挺低的。据说是画一下仿制药和原研药浓度随时间变化曲线，如果曲线下面积和峰值浓度两个指标，仿制药都在原研药的[0.8,1.25]区间内，仿制药就过了。我当时就问，我拿原研药的85%做成片剂，当成仿制药去测，是不是能过？好像是能过。

Dispelling the 80-125% Myth

• Myth: Misconception that a generic can contain between 80% and 125% of the active ingredient that is present in the brand-name. This is false!

• Fact: The “80% to 125%” criteria is part of a statistical tool when measuring drug concentration in the blood and drug exposure over time. It does not pertain to a range of allowable active ingredient in the generic.

• Bioequivalence is determined by pharmacokinetic (PK) parameters

– Ideal PK ratio of the generic drug to the reference drug is 1:1, or 1.00 (indicating perfect bioequivalence)

– Every time a human takes a drug product (either the brand or generic) the PK measurement varies a little bit

– FDA uses a statistical tool to account for this variability (the 90% confidence interval of the PK ratio should lie between 0.80 and 1.25)