TABLE 2

Characteristics of the adult data sets used for carvedilol model development

No.	Population	No. of Subjects	Dose (mg)	Application	Age (years)		Body Weight (kg)		Ref.
No.	Population	No. of Subjects	Dose (mg)	Application	Mean	Range	Mean	Range	Ref.
1	Healthy	10^{^a}	12.5	i.v. infusion^{^b}	29.5	21–39	73.9	56.5–98	(Neugebauer et al., 1990)
2	Healthy	3	12.5	i.v. infusion^{^b}	—	—	—	—	(Spahn et al., 1990)
3	Healthy	10^{^a}	50	Oral	29.5	21–39	73.9	56.5–98	(Neugebauer et al., 1990)
4	Healthy	3	50	Oral	—	—	—	—	(Spahn et al., 1990)
5	Healthy	9	25	Oral	28.4^{^c}	—	82.1^{^c}	—	(Zhou and Wood, 1995)
6	Healthy	7	25	Oral	32^{^d}	—	89.0^{^d}	—	(Zhou and Wood, 1995)
7	Healthy	7	6.4^e	Oral	29.7	24–37	71	56–100	(Behn, 2001)
8	Heart failure^{^f}^,^{^g}	20	6.25	Oral	55	39–64	89.5	60.8–113.1	(Tenero et al., 2000)
9	Heart failure^{^f}^,^{^g}	20	12.5	Oral	55	39–64	89.5	60.8–113.1
10	Heart failure^{^f}^,^{^g}	20	25	Oral	55	39–64	89.5	60.8–113.1
11	Heart failure^{^f}^,^{^g}	20	50	Oral	55	39–64	89.5	60.8–113.1

↵^a The number of patients included in pharmacokinetic analysis of S-carvedilol after i.v. and oral application were 6 and 7, respectively.
↵^b Intravenous infusion was given over 1 hour.
↵^c S.E.M. for age ±1.3 years and for weight ±3.2 kg.
↵^d S.E.M. for age ±2.4 years and for weight ±6.9 kg.
↵^e Dose administered as 0.09 mg/kg but normalized to total dose by multiplying with the average weight of the participants in the clinical trial.
↵^f Twenty patients completed the study (10 patients with NYHA III and 10 with NYHA IV heart failure).
↵^g The presented values for age and weight are the reported values for the initial study population (n = 22).