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NK ☆ India, 2019-06-26 09:25 (1926 d 12:38 ago) Posting: # 20360 Views: 3,472 |
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Hello everyone, I have a question with regards to FDA OGD guidance of Dihydroergotamine Nasal Spray" dated February 2019. The guidance specified that "baseline corrected PK data of AUC and Cmax should be used for bio-equivalence calculation" As per my understanding, Dihydroergotamine is neither endogenous nor available in the diet, then why baseline value is required? If it is required, what should be baseline sampling time points (-1h or -30 min or -15 min ...)? Thanks in advance. Regards NK Edit: URL corrected. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2019-06-26 12:10 (1926 d 09:52 ago) @ NK Posting: # 20361 Views: 2,985 |
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Hi NK, ❝ The guidance specified that "baseline corrected PK data of AUC and Cmax should be used for bio-equivalence calculation" ❝ As per my understanding, Dihydroergotamine is neither endogenous … Correct. ❝ … nor available in the diet, … Oh yes! Even when, it would practically not absorbed. ❝ … then why baseline value is required? IMHO, a bizarre idea. Ask the FDA. ❝ If it is required, … It is. If you would deviate from a guidance without a controlled correspondence you risk an RtR. ❝ … what should be baseline sampling time points (-1h or -30 min or -15 min ...)? The FDA’s general approach for a stable baseline is subtracting the mean of {-1 h, -0.5 h, pre-dose}. In your case likely it would be BQL anyhow.  — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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ElMaestro ★★★ Denmark, 2019-06-26 14:47 (1926 d 07:15 ago) @ Helmut Posting: # 20363 Views: 2,823 |
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Hi all, ❝ ❝ If it is required, … ❝ ❝ It is. If you would deviate from a guidance without a controlled correspondence you risk an RtR. It would be an interesting lawsuit, if the company gets an RtR for lack of baseline correction and sues the FDA because the formal requirement is meaningless. Perhaps a case where FDA could hide behind the fact that it is a draft and contains nonbinding recommendations blahblah? — Pass or fail! ElMaestro |
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nobody nothing 2019-06-26 12:21 (1926 d 09:42 ago) @ NK Posting: # 20362 Views: 2,806 |
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Sorry, but Copy -> Paste -> Nonsense on behave of the FDA as the most likely explanation? We will never know unless someone asks the oracle in Silver Springs, Maryland? — Kindest regards, nobody |
Ing. Helmut Schütz