BE Study Recommendations for Progesterone

Progesterone Draft Guidance: Recommended Studies to Document Bioequivalence

On Friday, October 30, 2015, FDA released a draft guidance, entitled “Bioequivalence Recommendations for Progesterone,” in which the Agency offers product specific guidance on the design of bioequivalence (BE) studies to support ANDAs for progesterone gel.

The guidance provides two studies to document BE of the test product to the reference product where the test product is qualitatively (Q1) and quantitatively (Q2) the same as the reference product:

  1. BE study with pharmacokinetic (PK) endpoints:

Single-dose, two-treatment, partial or fully replicated, crossover, fasting in vivo studies to be conducted in healthy postmenopausal females who are members of the general population. The study will measure progesterone in plasma, and bioequivalence will be based on progesterone according to a 90% confidence interval.

  1. BE study with clinical endpoint:

Randomized, double-blind, multiple-dose, two-treatment, parallel, in vivo studies to be conducted in females ages 18 to 45 years of age with hypothalamic amenorrhea or premature ovarian failure. Bioequivalence will be based on bleeding according to a 90% confidence interval.

The document states that comparative dissolution testing should be conducted on 12 dosage units of all strengths of the test and reference products. Specifications will be determined upon review of the ANDA.

The draft guidance also provides a number of additional comments regarding the BE study with clinical endpoint, which can be found here.

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