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. Author manuscript; available in PMC: 2019 Aug 27.
Published in final edited form as: Drug Deliv Transl Res. 2018 Oct;8(5):1180–1190. doi: 10.1007/s13346-018-0538-0

Table 2.

Outline of study design and specimen collections. For the vaginal PK study, female pigtailed macaques (N = 6) were treated with 0.5 or 1.5 ml IQB4012 that was applied in the posterior vagina, proximal to the cervix. For the rectal PK study, 1 or 4 ml IQB4012 was applied in the rectum of N = 6 female pigtailed macaques. Specimens indicated were collected immediately before (0 h) and at 2, 4, and 24 h after each weekly gel application

Sample 0 h* 2 h 4 h 24 h
Blooda (vaginal and rectal PK) X X X X
Vaginal multiswabb (vaginal PK) X X X X
Rectal spearsc (vaginal and rectal PK) X X X X
Vaginal pinch biopsiesd (vaginal PK) - - X X
Rectal pinch biopsiese (vaginal and rectal PK) - - X X
Vaginal pHf (vaginal PK) X X X X
a

2-ml CPT tubes

b

Vaginal multiswab device loaded with eight Weck-Cel sponges; four proximal and four distal

c

Two rectal wicks/animal/time point

d

VAGINAL: three pinch biopsies/animal/time point (one prox, one med, one dist)

e

RECTAL: two pinch biopsies/animal/time point

f

Vaginal pH: pH indicator strips