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1.
Fig. 2

Fig. 2. From: Pharmacodynamic Studies to Demonstrate Bioequivalence of Oral Inhalation Products.

Dose response for fluticasone propionate doses on exhaled nitric oxide (adapted from )

Leslie Hendeles, et al. AAPS J. 2015 May;17(3):758-768.
2.
Fig. 1

Fig. 1. From: Pharmacodynamic Studies to Demonstrate Bioequivalence of Oral Inhalation Products.

Relationship between drug at site of action and biomarkers of anti-inflammatory effects in the airways

Leslie Hendeles, et al. AAPS J. 2015 May;17(3):758-768.
3.
Fig. 3

Fig. 3. From: Pharmacodynamic Studies to Demonstrate Bioequivalence of Oral Inhalation Products.

Dose response for fluticasone propionate doses on exhaled nitric oxide (adapted from ). Zero dose is placebo

Leslie Hendeles, et al. AAPS J. 2015 May;17(3):758-768.
4.
Fig. 7

Fig. 7. From: Pharmacodynamic Studies to Demonstrate Bioequivalence of Oral Inhalation Products.

Changes in iVaw in a patient with a large response (FEV1 > 5%) to the Roflumilast treatment (top). Changes in iVaw in a patient with no response (FEV1 ≤ 5%) to the Roflumilast treatment (bottom)

Leslie Hendeles, et al. AAPS J. 2015 May;17(3):758-768.
5.
Fig. 5

Fig. 5. From: Pharmacodynamic Studies to Demonstrate Bioequivalence of Oral Inhalation Products.

Bronchodilator response measured as percent increase in forced expiratory volume in 1 s (FEV 1) 1 h after administration of single doses of formoterol 12 and 24 μg (adapted from )

Leslie Hendeles, et al. AAPS J. 2015 May;17(3):758-768.
6.
Fig. 6

Fig. 6. From: Pharmacodynamic Studies to Demonstrate Bioequivalence of Oral Inhalation Products.

Provocative concentration of methacholine required to decrease the forced expiratory volume in 1 s by 20% (PC 20) measured 1 h after administration of single doses of formoterol 12 and 24 μg, on separate days, at the same time of day, in ten patients who completed the study. A significant dose–response relationship was noted; the geometric mean (95% confidence interval) was 7 mg/ml (2–22 mg/ml) after the 12-μg dose and 16 mg/ml (5–45 mg/ml) after the 24-μg dose (p < 0.001) (adapted from )

Leslie Hendeles, et al. AAPS J. 2015 May;17(3):758-768.
7.
Fig. 4

Fig. 4. From: Pharmacodynamic Studies to Demonstrate Bioequivalence of Oral Inhalation Products.

Serum cortisol–time curves of an individual healthy young, white female subject participating in a single-centre, randomised, double-blind, double-dummy, four-period, 4-day repeat-dose crossover study with baseline evaluation comparing two strengths (i.e. 50/100 and 50/500 μg) of a salmeterol/fluticasone propionate containing TEST DPI (T1 FP low dose; T2 FP high dose) and Seretide Diskus® (R1 FP low dose; R2 FP high dose). There are two irregular profiles (blue and black curves) with high cortisol levels versus the BL-profile despite (low dose) FP treatment and atypical daytime peaks. Findings may point either to sleep shifts or stress exposure or capturing of cortisol pulses in two out of four individual profiles. Note the substantial impact on AUC outcomes, depending on sampling schedule

Leslie Hendeles, et al. AAPS J. 2015 May;17(3):758-768.

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