The half-life elimination rate of the parent compound ranges from 7 to 37 h while that of some metabolites does so from 11 to 50 h. Isotretinoin crosses the placenta and is recognized as a strong teratogenic compound.

Answer: accept

The

half

life

elimination

rate

of

the

parent

compound

ranges

from

to

h

while

that

of

some

metabolites

does

so

from

to

h

Isotretinoin

crosses

the

placenta

and

is

recognized

as

a

strong

teratogenic

compound


The median elimination half-life (T1/2) of CLR457 was estimated from the observed accumulation ratio at steady state and ranged between 7.92 to 16.8 h (Table 5).

Answer: accept

The

median

elimination

half

life

T

of

CLR

was

estimated

from

the

observed

accumulation

ratio

at

steady

state

and

ranged

between

to

h

Table


Mean AUC (area under curve)'s of CPDX obtained were 9.60, 31.35 and 17.89 micrograms.hr/ml, respectively for the 3 dosages.

Answer: accept

Mean

AUC

area

under

curve

's

of

CPDX

obtained

were

and

micrograms

hr

ml

respectively

for

the

dosages


In a study of 46 patients with advanced breast cancer treated with metronomic cyclophosphamide and capecitabine along with bevacizumab, an overall response rate of 48% was observed with minimal toxicity (Dellapasqua et al, 2008).

Answer: accept

In

a

study

of

patients

with

advanced

breast

cancer

treated

with

metronomic

cyclophosphamide

and

capecitabine

along

with

bevacizumab

an

overall

response

rate

of

was

observed

with

minimal

toxicity

Dellapasqua

et

al


At the steady-state, the clearance (CL) of MTX (6.28 +- 2.79 l h(-1)) was correlated with its CL(R) (r(s) = 0.79, p < 0.0001) which accounted for 61% (SD 26%) of the former.

Answer: accept

At

the

steady

state

the

clearance

CL

of

MTX

l

h

was

correlated

with

its

CL

R

r

s

p

which

accounted

for

SD

of

the

former


An estimated late phase t1/2 of 48 h was also observed following the oral dose.

Answer: accept

An

estimated

late

phase

t

of

h

was

also

observed

following

the

oral

dose


Cetirizine concentration–time course analyses

After treatment with 4 mg/kg cetirizine once daily for 3 days, median (range) maximum observed plasma concentration was 5.6 µg/mL (4.6–10.8) and observed 7 h after the last administration of cetirizine.

Answer: accept

After

treatment

with

mg

kg

cetirizine

once

daily

for

days

median

range

maximum

observed

plasma

concentration

was

µ

g

mL

and

observed

h

after

the

last

administration

of

cetirizine


Maximal concentrations were reached within approximately 15 min for all active treatments.

Answer: accept

Maximal

concentrations

were

reached

within

approximately

min

for

all

active

treatments


3.4.2. Pharmacokinetic Comparison of Curcumol

The results revealed that curcumol was rapidly absorbed into the circulatory system and reached its peak concentration approximately 2 h after oral administration of R-CR extract.

Answer: accept

The

results

revealed

that

curcumol

was

rapidly

absorbed

into

the

circulatory

system

and

reached

its

peak

concentration

approximately

h

after

oral

administration

of

R

CR

extract


The clearance of phenylacetylglutamine in contrast averaged 455±62 ml/min/1.73m2, approximately three quarters of the estimated renal plasma flow rate.

Answer: accept

The

clearance

of

phenylacetylglutamine

in

contrast

averaged

ml

min

m

approximately

three

quarters

of

the

estimated

renal

plasma

flow

rate


The plasma concentrations of dihydroergotoxine produced by the three preparations, measured using a specific and sensitive radioimmuno-assay method over 24 h, exceeded 200 pg ml-1 for approximately 5 h and decayed in a biphasic manner with a slowest measured half-life of 12-14 h.

Answer: accept

The

plasma

concentrations

of

dihydroergotoxine

produced

by

the

three

preparations

measured

using

a

specific

and

sensitive

radioimmuno

assay

method

over

h

exceeded

pg

ml

for

approximately

h

and

decayed

in

a

biphasic

manner

with

a

slowest

measured

half

life

of

h


Pycnogenol constituents and metabolites in plasma after a single dose of 300 mg

Maximum plasma concentrations of ferulic acid were seen already after 0.5 to 1 h. Concentrations decreased thereafter and remained almost constant before revealing another increase towards the end of experimental period.

Answer: accept

Maximum

plasma

concentrations

of

ferulic

acid

were

seen

already

after

to

h

Concentrations

decreased

thereafter

and

remained

almost

constant

before

revealing

another

increase

towards

the

end

of

experimental

period


Ataluren Plasma Concentration‐Time Profile

Following administration of single escalating doses of ataluren, observation of the plasma concentration‐time profiles revealed rapid absorption of ataluren, with Tmax occurring between 0.875 and 2.5 hours (median values) (Figure 1).

Answer: accept

Following

administration

of

single

escalating

doses

of

ataluren

observation

of

the

plasma

concentration

time

profiles

revealed

rapid

absorption

of

ataluren

with

Tmax

occurring

between

and

hours

median

values

Figure


Therapeutic drug monitoring and application of method

Pharmacokinetic applications, such as bioavailability and bioequivalence, are reliable with an LLOQ of 0.100 μg/mL, and because of this limit, this method may be sufficient to quantify imatinib within 3–5 half-lives or approximately 5% of the expected peak levels when administered at a dose of 400 mg.26,27

Answer: accept

Pharmacokinetic

applications

such

as

bioavailability

and

bioequivalence

are

reliable

with

an

LLOQ

of

μ

g

mL

and

because

of

this

limit

this

method

may

be

sufficient

to

quantify

imatinib

within

half

lives

or

approximately

of

the

expected

peak

levels

when

administered

at

a

dose

of

mg


Results and Discussion
In vivo biodistribution studies

Considering a steady state distribution volume of metformin in mice of 1840 mL/kg43, the mean percentage release at 1 and 6 h is shown in Table S3.

Answer: accept

Considering

a

steady

state

distribution

volume

of

metformin

in

mice

of

mL

kg

the

mean

percentage

release

at

and

h

is

shown

in

Table

S


In 5/34 patients who received a prolonged leucovorin rescue due to a delayed MTX elimination t1/2 alpha was greater than 3.1 h.

Answer: accept

In

patients

who

received

a

prolonged

leucovorin

rescue

due

to

a

delayed

MTX

elimination

t

alpha

was

greater

than

h


PK profile of Br-NBP after multiple dose of BZP in rats

As shown in Figure 3, Table 2, the Cmin values of Br-NBP were under the LLOQ (5 ng/mL) at 5–7 day.

Answer: accept

As

shown

in

Figure

Table

the

Cmin

values

of

Br

NBP

were

under

the

LLOQ

ng

mL

at

day


In an animal study, we found that multiple doses of RFP significantly decreased the area under the concentration-time curve, the maximum concentration and the bioavailability of orally administered LZD by 48%, 54% and 48%, respectively.

In

an

animal

study

we

found

that

multiple

doses

of

RFP

significantly

decreased

the

area

under

the

concentration

time

curve

the

maximum

concentration

and

the

bioavailability

of

orally

administered

LZD

by

and

respectively

Answer: accept


This study assessed relative bioavailability of a new subcutaneous formulation, test (T) (dalteparin sodium 95000 IU/3.8 mL) with the branded product (R) in healthy subjects to meet the regulatory requirements of bioequivalence in the US.

This

study

assessed

relative

bioavailability

of

a

new

subcutaneous

formulation

test

T

dalteparin

sodium

IU

mL

with

the

branded

product

R

in

healthy

subjects

to

meet

the

regulatory

requirements

of

bioequivalence

in

the

US

Answer: accept