ANVISA and replicate designs [Regulatives / Guidelines]

posted by earlybird – 2016-05-19 16:10 (2074 d 05:49 ago) – Posting: # 16334
Views: 9,191

Dear D. Labes,

recently we got a letter from ANVISA with the following ...

"The protocol proposes the possibility to scale up Cmax values based on a within-subject coefficient of variation (CV%) higher than 40% for the reference drug.

More recently, Anvisa decided to follow the WHO instructions specified in “MULTISOURCE (GENERIC) PHARMACEUTICAL PRODUCTS: GUIDELINES ON REGISTRATION REQUIREMENTS TO ESTABLISH
INTERCHANGEABILITY. REVISION (JULY 2014)”, where the parameters to be followed in this kind of study are defined. We will accept parameters starting at CVWR > 30%. Therefore, please follow the guidelines above or EMA guidelines that have the same study assessment criteria, and the correct regulatory constant. Only Cmax intervals can be extended and the regulatory constant is K = 0.760. GMR should be within the 80%-125% range.
The correct study design for this case is the full replicate design, i.e. a 4-period design. Therefore, the study design is adequate for its purpose."

telling us to do the same as EMA.

Hope this helps,
Greatings from earlybird, Oberbayern, Bavaria

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