Bioequivalence and Bioavailability Forum

Obinoscopy
★

USA,
2025-12-07 15:59
(178 d 07:11 ago)

Posting: # 24522
Views: 2,199

Data for MSc Thesis on Bioequivalence [General Statistics]

Hi guys,

I am an MSc Biostatistics student with UTHealth, Houston. For my thesis, I want to conduct several statistical analysis on some pharmacokinetic parameters like AUCt, AUCinf, Cmax. What I need are individual concentration-time tables for de-identified participants.

My aim is to study the variability of the point estimates of the different PK parameters and their MSEs using different NCA quantification models. I don't know where to get such data. I was told the fda will not grant my request if I ask them. I also don't mind if the data is simulated.

Please any assistance will be invaluable.

Regards,
Obinoscopy

—
Scopy

Helmut ★★★ Vienna, Austria, 2025-12-08 14:12 (177 d 08:58 ago) @ Obinoscopy Posting: # 24523 Views: 1,876	Data for MSc Thesis on Bioequivalence Post reply
	Hi Scopy, how many studies do you need? There are a few with profiles in the public domain (papers, textbooks). Which designs are you interested in? — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes

Obinoscopy
★

USA,
2025-12-08 21:57
(177 d 01:13 ago)

@ Helmut
Posting: # 24524
Views: 1,864

Data for MSc Thesis on Bioequivalence

Post reply

❝ how many studies do you need? There are a few with profiles in the public domain (papers, textbooks). Which designs are you interested in?

Hi Helmut,

I am looking at 15 to 20 studies. My focus is on cross-over studies with sample sizes that meet the minimum ICH requirement. I also want to limit my study to molecules with not too long half lifes (short, intermediate) which are both Immediate Release. I also want to include both molecules with low and high intra-subject variability.

—
Scopy

Helmut
★★★

Vienna, Austria,
2025-12-10 12:13
(175 d 10:57 ago)

@ Obinoscopy
Posting: # 24530
Views: 1,769

Data for MSc Thesis on Bioequivalence

Post reply

Hi Scopy,

a few data from the public domain. Ref.#1 contains SD/MD data and #2 SD:

Sauter R, Steinijans VW, Diletti E, Böhm E, Schulz H-U. Presentation of results from bioequivalence studies. Int J Clin Pharm Ther Toxicol. 1992; 30/Suppl.1: S7-30.
or (same data)
Sauter R, Steinijans VW, Diletti E, Böhm E, Schulz H-U. Presentation of results from bioequivalence studies. Int J Clin Pharm Ther Toxicol. 1992; 30(7): 233–56.
or (same data)
Hauschke D, Steinijans V, Pigeot I. Bioequivalence Studies in Drug Development. New York: Wiley & Sons; 2007. p. 123–155.
Health Canada. Guidance Document. Conduct and Analysis of Comparative Bioavailability Studies. Ottawa. 2023/01/30. Online.

Simulation scripts in [image]

for a one-compartment model and biphasic profiles in this article. See also another article.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

paulhurleyuk ☆ NE UK, 2025-12-09 19:19 (176 d 03:50 ago) @ Obinoscopy Posting: # 24528 Views: 1,824	Data for MSc Thesis on Bioequivalence Post reply
	❝ I also don't mind if the data is simulated. I don't know if its helpfull, but theres a couple of R packages that deal with simulating time-concentration data, specifically caffsim and PKPDsim that might be of some use. Paul.

Data for MSc Thesis on Bioequivalence [General Sta­tis­tics]

Data for MSc Thesis on Bioequivalence

Data for MSc Thesis on Bioequivalence

Data for MSc Thesis on Bioequivalence

Data for MSc Thesis on Bioequivalence

Data for MSc Thesis on Bioequivalence [General Statistics]