Table 1.

Studies Included in the Population Pharmacokinetic Data Set

Study	Title	Regimen	n (PK Sampling)	PK Sampling Schedule	Reference
VER001‐4	Phase 2, Randomized, Open‐Label, Multi‐Center Study to Evaluate the Safety and Efficacy of Dalbavancin Versus Vancomycin in the Treatment of Catheter‐Related Bloodstream Infections With Suspected or Confirmed Gram‐Positive Bacterial Pathogens (2002)	1000 mg on day 1 and 500 mg on day 8	30	Days 1, 3‐8, EOT, TOC	Raad et al (2005)29
VER001‐5	Phase 2, Pilot, Randomized, Open‐Label, Multi‐Center Study to Evaluate the Safety and Efficacy of Dalbavancin Versus Investigator/Physician‐Designated Comparator in Skin and Soft Tissue Infection (2001)	1100 mg on day 1; 1000 mg on day 1 and 500 mg on day 8	34	Day 8, EOT, follow‐up	Seltzer et al (2003)30
VER001‐9	Phase 3, Randomized, Double‐Blind, Multi‐Center Study to Evaluate the Safety and Efficacy of Dalbavancin Versus Linezolid in the Treatment of Complicated Skin and Soft Tissue Infections with Suspected or Confirmed Gram‐Positive Bacterial Pathogens (2003)	1000 mg on day 1 and 500 mg on day 8	468	Days 1, 4, 7, 8, EOT, TOC	Jauregui et al (2005)31
DUR001‐303	A Phase 3b, Double‐Blind, Multi‐Center, Randomized Study to Compare the Efficacy and Safety of Single Dose Dalbavancin to a 2 Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections	Intravenous single‐dose dalbavancin: 1500 mg on day 1 (1000 mg for patients with CLCR < 30 mL/min not receiving dialysis), placebo intravenously on day 8 Intravenous 2‐dose dalbavancin: 1000 mg on day 1, 500 mg on day 8 (750 mg on day 1 and 375 mg on day 8 for patients with CLCR < 30 mL/min not receiving dialysis)	171	Day 1 (1 hour ± 30 minutes); 18 ± 2 hours, 23 ± 4 hours, and 36‐48 hours after day 1 dose	Dunne et al (2016)24

CLCR, creatinine clearance; EOT, end of therapy; TOC, test of cure.