Special Issue on Biological Engineering & Natural Science, June 2014

ISSN: 2347-6818 2014 | Published by The Standard International Journals (The SIJ) 15



AbstractBased on the robust design (RD) principle proposed by Taguchi, the primary objective of this paper
is to develop a strategy in order to obtain a safe and effective medication in the drug development program by
using three sequential steps, i.e. the design of experiments, estimation, and optimization. Firstly, the extreme
vertices mixture design is experimentally conducted for the formulation of microemulsion-based hydrogel.
Secondly, the response surface methodology-based quartic models are proposed to estimate the multiple output
responses as functions of the input factors. Finally, a new RD optimization model consisting of weighted-sum
model and epsilon-constrained method is proposed to consider the trade-off between multiple responses based
on the mean squared error criterion and the boundary specification on the process bias. The final results
showed that a number of efficient solutions can be achieved in order to find the optimal formulation of
microemulsion-based hydrogel.
KeywordsEpsilon-Constrained Method; Microemulsion-based Hydrogel; Multiple Responses Optimization;
Robust Design; Weighted Sum Model.
AbbreviationsDesign of Experiments (DoE); Food and Drug Administration (FDA); Least Squares Method
(LSM); Mean Squared Error (MSE); Response Surface Methodology (RSM); Robust Design (RD).

I. INTRODUCTION
OBUST design is often identified as one of the most
powerful methodologies for quality improvement
purposes among the design methods currently studied
in the engineering community. Since introduced by Taguchi
in 1986, RD consists of two basic steps based on
experimental design and two steps model for analysis of the
resulting data. Unfortunately, the technique proposed by
Taguchi to solve the RD problem was criticized about the
assumptions, experiment design and statistical analysis by
Leon et al., (1987), Box et al., (1988), and Nair (1992). Based
on RSM, Vining & Myers (1990) proposed the dual
responses approach where the process mean and process
variance are estimated as two separate functions of input
factors by using Least Squares Method (LSM). In addition,
the dual responses approach can be seen as an alternative way
to achieve the optimal solutions. From this proposal, the
principal procedure of RD is generated and used up to now
with three sequential stages, such as experimental design,
estimation, and optimization to obtain the optimal factor
settings. In terms of optimization, the variance is minimized
as the process mean is kept at the desired target value in the
dual responses approach. However, the process bias (i.e. the
absolute value of the process mean and the target value) and
process variance are not minimized simultaneously in the
dual responses approach. Therefore, Lin & Tu (1995)
proposed the MSE model where the process bias and process
variance are simultaneously minimized. Cho et al., (1996),
R
*Department of Industrial &Management Systems Engineering, Dong-A University, Busan, 604-714, REPUBLIC OF KOREA.
E-Mail: letuanhoqnu{at}gmail{dot}com
**Corresponding Author, Department of Industrial &Management Systems Engineering, Dong-A University, Busan, 604-714,
REPUBLIC OF KOREA. E-Mail: sshin{at}dau{dot}ac{dot}kr
***Co-won Nuclear Engineering Center, Co-Won Co. Ltd, Busan 604-714, REPUBLIC OF KOREA.
E-Mail: yonghee212{at}gmail{dot}com
****College of Pharmacy, Dongguk University-Seoul, Goyang, Gyeonggi 410-820, REPUBLIC OF KOREA.
E-Mail: shjeong{at}dongguk{dot}ac{dot}kr
*****Department of Production Technology Education, King Mongkut's University of Technology Thonburi, Bangkok 10140, THAILAND.
E-Mail: sittichai.kae{at}kmutt{dot}ac{dot}th
Tuan-Ho Le*, Sangmun Shin**, Yonghee Lee***, Seong Hoon Jeong**** & Sittichai Kaewkuekool*****
Robust Design Multiple Responses
Modeling and Optimization for
Microemulsion-based Hydrogel
Formulation
Special Issue on Biological Engineering & Natural Science, June 2014
ISSN: 2347-6818 2014 | Published by The Standard International Journals (The SIJ) 16
Koksoy & Doganaksoy (2003), and Ding et al., (2004)
introduced the weighted sum model to consider the trade-off
between the process bias and process variance. The
customers preference in terms of tolerance and specification
of an upper boundary on bias is integrated in the bias
specified model based on the -constraint method proposed
by Shin & Cho (2005, 2006). In addition, Shin et al., (2011)
attempted to customize current RD methods for a
pharmaceutical experimental design problem in order to
obtain optimal drug formulations. The trade-off problem as
well as the specification of the boundary of the responses
problem is considered in Le et al., (2014) in the
pharmaceutical environment.
The pharmaceutical industry is facing numerous of
challenges such as the demands of competition, the strict
regulation of new drugs development process as well as the
careful control of the Food and Drug Administration (FDA)
over the quality of these products [Peterson et al., 2009]. The
development of a new drug is conducted and examined
closely in the laboratory experiments environment before it
can be applied to animal or human subjects. However,
determining the better approaches in obtaining the optimal
drug formulations is still the considerable challenge to the
researchers. By definition, the drug formulations are the
mixture of many components. In the early stage of the drug
development, the mixture design techniques determine
largely the quality of the pharmaceutical products. In
addition, a scientific approach is required to illustrate the
output quality characteristics of the drug formulations as the
functional relationships of the input proportions. Moreover,
the trade-off between multiple output quality characteristics
of drug formulations and the boundary specifications of
responses are also the noticeable problems in order to identify
the optimal formulations.
Therefore, the primary objective of this paper is to
develop a systematic procedure to identify the optimal
solution of drug formulations based on three sequential
stages, i.e., the experimental designs, model parameter
estimation, and optimization. Firstly, a mixture design based
on extreme vertices design is implemented to investigate the
information between the control factors and the output
responses. Secondly, the multiple output responses are
estimated as the full quartic functions of the input variables,
instead of normal quadratic form in most researches in the
literature. Thirdly, the MSE is utilized as a comparative
criterion between multiple responses. An alternative RD
optimization model based on the combination of the weighted
sum model and the epsilon-constrained method is proposed to
identify the optimal drug formulations. A pharmaceutical
case study with microemulsion-based hydrogel formulation is
provided and solved using MINITAB and MATLAB
software packages to illustrate the purpose of the proposed
optimization model. An overview of the proposed RD
method is illustrated in figure 1.

Figure 1: An Overview of the Proposed RD Method
II. MODEL DEVELOPMENT
2.1. Design of Experiments
Design of Experiments (DoE) is an efficient, structured, and
planned statistical method to conduct experiments so that the
input and output variables can be analyzed to yield the
necessary information. The choosing the DoE methods
requires careful consideration of several consideration before
actually doing the experiment such as the number of factors,
the levels of factors, and the relevance of interactions
between factors. The proportions within the mixture, not the
amount of their components, are often considered in the
mixture designs. Therefore, the proportions of all ingredients
in the mixture must sum to 100%, as illustrated by the
equation

=1
=
1
++

= 1, where

0 for all
= 1, , . There are three standard design techniques in the
mixture designs, i.e., simplex-lattice, simplex-centroid, and
extreme vertices designs. As there are both upper and lower
bound constraints on the components, the extreme vertices
designs are often used to conduct the experimental designs
for the mixture problems. The extreme vertices for two three-
component designs with both upper and lower constraints are
displayed in figure 2. The associated experimental format is
shown in table 1 in which x, , and s represent the vector of
control variables, mean and standard deviation of replicated
responses, respectively.

Figure 2: The Extreme Vertices Design for Two Different Three-
Component Designs with Both Upper and Lower Constraints
Table 1: Experimental Format
Runs
Control factors x Response

Replications

1
Design Matrix

11

1

1
s
1

2
21

2

2
s
2


n
1

Input
Variables

Optimal
Solutions
DoE Estimation
Optimization
Response
1
Response
n
Special Issue on Biological Engineering & Natural Science, June 2014
ISSN: 2347-6818 2014 | Published by The Standard International Journals (The SIJ) 17
2.2. Estimation
Normally, the functional relationship between the output
response and the input variables is often not known, but can
be modeled by some methodologies with a suitable degree of
accuracy. RSM is used as the most popular approach to
model the functional between the input and output factors.
The main idea of RSM is to use a sequence of designed
experiments to obtain optimal responses by estimating input-
response functional forms when the exact functional
relationships are not known or very complicated [Box &
Draper, 1987; Khuri & Cornell, 1987; Myers & Montgomery,
2002]. Based on the RSM, the functional relationship
between the response and the control factors can be
represented as
= + (1)
where x is a vector of control factors, is a column vector of
model parameters, and is the random errors. The model
parameters are often estimated by LSM as

. (2)
The model parameters of mean and standard deviation
functions are estimated as follows:

(3)

. (4)
Normally, the quadratic response surface functions are
used in most RD problems. However, the full quartic
polynomial functions are proposed to conduct the functional
relationships between the input and output factors due to the
coefficient of determination
2
of the data in the case study.
2.3. Optimization
In pharmaceutical industry, quality characteristics of drug
products such as pH, viscosity, and particle size are often
considered simultaneously. The MSE is used as a
comparative criterion in this study and the MSE of each
quality characteristics can be calculated as follows:

2
+

2
.
(5)
However, these output responses are often conflicted in
the real situations. Therefore, the trade-off between these
responses needs to be considered through the preference
information from a human decision makers opinions. The
weighted sum model is suitable to perform that problem. The
weight of each response can be chosen based on their relative
importance in the problems. Another issue in the
pharmaceutical case study is that the environment of the
reaction of the compounds in the drug (pH), viscosity, and the
particle size must be in a specific limitation on the bias. Both
these issues can be solved in the hybrid model to find the
robust optimal solutions (i.e., the optimal factor settings, x
*
).
Generally, the RD hybrid optimization model can be
performed as follows:
Minimize

MSE

(x)

=1

Subject to

for all = 1, ,

=1
= 1
(6)
where

denotes the q
th
weight,

is the q
th
upper level of the q
th
constraint on the bias
function,

is the q
th
upper level of the q
th
constraint on the
standard deviation function,
MSE

(x) is the mean squared error for the q

th
response.
III. CASE STUDY
Evaluations of the formulations are conducted whiling
considering three input control factors (i.e., benzyl alcohol,
polyoxyl 35, and DGM) and eight fixed factors (i.e.,
itraconazole, povidone K17, isoprophyl alcohol, D-
Limonene, colloidal silicone, methyl paraben, propylparaben,
and water). In Le et al., (21014), two output responses the pH
and particle size are considered. However, three output
responses, i.e., the pH, viscosity, and particle size are
considered and assumed to depend only on the relative
proportions of the three ingredients in the mixture design of
this study. The proportions of these ingredients must be
summed to 100%.
In the attempt to analyze the formulations of
microemulsion-based hydrogel, the environment to break up
the compounds in the drug must be examined and be tested
closely. Therefore, the pH values (
1
) must be repeated many
times (replication) and the bias as well as the standard
deviation must be lie in the tight specification. In addition,
the viscosity (
2
) as well as the particle size of drug (
3
) is a
significantly important factor which is also in a stringent
bound. The required specifications are:
The target value, the maximum allowable bias, and the
maximum allowable response standard deviation of
the pH are 6.19, 0.15, and 0.1, respectively.
The target value, the maximum allowable bias, and the
maximum allowable response standard deviation of
the viscosityare1140, 70, and 2.236, respectively.
The target value and the maximum allowable bias of
the particle size are 75.00 and 1.5, respectively.
The total amount of three control factors always equals
80, and the bound values for
1
are in the range [15, 25],
while the bound values for both
2
and
3
are in the same
range [25, 35]. Based on these conditions, the extreme
vertices mixture design is used to conduct the experimental
design. By using MINITAB software package, the extreme
vertices mixture design with 19 experimental runs, the
replications of the each response as well as the corresponding
mean and standard deviation of each response are
demonstrated in table 2.


Special Issue on Biological Engineering & Natural Science, June 2014
ISSN: 2347-6818 2014 | Published by The Standard International Journals (The SIJ) 18
Table 2: The Extreme Vertices Design for the Control Factors
Runs
Control Factors Responses

(10
3
, cp)

(nm)

1 25 25 30 6.44 6.48 6.45 6.4567 0.0208 471 557 698 575.33 114.61 28.37
2 15 35 30 6.50 6.52 6.54 6.5200 0.0200 646 775 743 721.33 67.17 128.47
3 20 25 35 6.68 6.69 6.70 6.6900 0.0100 356 450 432 412.67 49.89 253.41
4 15 30 35 6.50 6.51 6.52 6.5100 0.0100 451 574 521 515.33 61.70 98.22
5 20 35 25 6.49 6.44 6.45 6.4600 0.0265 370 335 361 355.33 18.18 490.93
6 25 30 25 6.64 6.64 6.63 6.6367 0.0058 367 480 400 415.67 58.11 502.00
7 15 32.5 32.5 6.42 6.41 6.43 6.4200 0.0100 382 435 403 406.67 26.69 212.41
8 22.5 25 32.5 6.52 6.51 6.52 6.5167 0.0058 692 884 890 822.00 112.62 128.60
9 22.5 32.5 25 6.43 6.44 6.47 6.4467 0.0208 453 432 401 428.67 26.16 261.73
10 25 27.5 27.5 6.63 6.63 6.65 6.6367 0.0116 403 495 525 474.33 63.57 292.69
11 17.5 35 27.5 6.57 6.59 6.58 6.5800 0.0100 854 984 1060 966.00 104.17 262.59
12 17.5 27.5 35 6.46 6.46 6.46 6.4600 0.0000 540 654 591 595.00 57.11 49.29
13 20 30 30 6.57 6.58 6.57 6.5733 0.0058 520 601 589 570.00 43.71 5.46
14 22.5 27.5 30 6.46 6.48 6.47 6.4700 0.0100 820 957 970 915.67 83.10 190.31
15 17.5 32.5 30 6.49 6.50 6.49 6.4933 0.0058 518 531 523 524.00 6.56 126.45
16 20 27.5 35.5 6.50 6.51 6.52 6.5100 0.0100 503 634 659 598.67 83.79 140.09
17 17.5 30 32.5 6.52 6.51 6.51 6.5133 0.0058 382 493 459 444.67 56.87 308.40
18 20 32.5 27.5 6.46 6.50 6.48 6.4800 0.0200 731 889 946 855.33 111.38 57.71
19 22.5 30 27.5 6.47 6.48 6.47 6.4733 0.0058 358 334 362 351.33 15.14 62.76

Based on the data in table 2, the model parameters of the
mean and standard deviation functions of responses
1
and
2

and the model parameters of the function of response
3
can
be estimated by using Equations (2), (3), and (4). The
estimated mean and standard deviations functions of
responses
1
and
2
and the estimated function of response

3
can be represented respectively as follows:

x = 46.8822
1
+25.0460
2
+10.2013
3
1.7261
1

2
1.2891
1

3
0.8542
2

3
0.0026
1

1

2

0.0121
1

1

3

0.0051
2

3
+ 0.0005
1
2

3
+ 0.0006
1

2
2

3
+0.0000
1

3
2
0.0001
1

2
(
1

2
)
2
0.0001
1

3
(
1

3
)
2
0.0001
2

3
(
2

3
)
2

2
= 86.96%

1
x = 7.5846
1
1.1715
2
0.1005
3
0.1577
1

2
0.1876
1

3
+0.0366
2

3
0.0024
1

0.0017
1

+0.0004
2

3
+0.0001
1
2

3
0.0000
1

2
2

3
+0.0000
1

3
2
0.0000
1

2
(
1

2
)
2
0.0000
1

3
(
1

3
)
2
+0.0000
2

3
(
2

3
)
2

2
= 89.59%

x = 3219.3
1
110650
2
18042
3
+2837.4
1

2
285.7
1

3
+ 3225.1
2

3
19.463
1

1

2

5.6002
1

1

3

+ 25.002
2

2

3
0.11481
1
2

3
1.6457
1

2
2

3
+ 0.25407
1

3
2
+ 0.34162
1

1

2

2
0.24745
1

1

3

2
+ 0.49789
2

3
(
2

3
)
2

2
= 85.22%

2
x = 29443
1
12422
2
17567
3
479.31
1

2
325.31
1

3
+ 766.61
2

3
8.9221
1

1

2

11.543
1

1

3

1.7438
2

2

3
+0.33437
1
2

3
0.03873
1

2
2

3
0.21295
1

3
2
0.028766
1

2
(
1

2
)
2

0.031062
1

3
(
1

3
)
2
+ 0.1141
2

3
(
2

3
)
2

2
= 83.17%

3
x = 59210
1
+17742
2
1735.7
3
+1008.8
1

2
+ 1464.7
1

3
440.88
2

3
+ 19.705
1

1

2

+ 7.5786
1

1

3

6.6539
2

2

3
0.42878
1
2

3
+ 0.21437
1

2
2

3
0.36503
1

3
2
+ 0.16503
1

2
(
1

2
)
2
+ 0.10482
1

3
(
1

3
)
2
0.11853
2

3
(
2

3
)
2

2
= 93.36%.
All coefficients of determination
2
of the estimated
functions over 80 % show the reliable and efficient
estimation results. The proposed RD optimization model for
this study can be specified as follows:
Minimize =
1
MSE
1
+
2
MSE
2
+
3
MSE
3

Subject to
1

x
1

1mean

1
x
1


2

x
2

2mean

2
x
2


3
x
3

3mean

where
1
= 6.19,
1mean
= 0.15,
1
= 0.1,
2
= 1140,
2mean
=
70,
2
= 2.236,
3
= 75,
3mean
= 1.5, MSE
1
=
1
x

2
+
1
2
x, MSE
2
=
2
x
2

2
+
2
2
x, and MSE
3
=

3
x
3

2
+
3
2
x.
Using MATLAB software, the proposed RD
optimization model can automatically generate a number of
Special Issue on Biological Engineering & Natural Science, June 2014
ISSN: 2347-6818 2014 | Published by The Standard International Journals (The SIJ) 19
optimal factor settings
1
,
2
,
3
based on the given weights

1
,
2
, and
3
. The efficient solutions for the pH value
MSE
1
, viscosity MSE
2
, and particle size MSE
3
with different
weights obtained from the RD hybrid model are shown in
table 3. The efficient Pareto solutions are drawn in the
objective space with each pairs MSE values of each response,
as shown in figure 3.
Table 3: The Optimal Solutions with Different Weights

0.97 0.01 0.02 17.039 32.996 29.972 0.047006 32585 8492.2 495.74
0.85 0.05 0.1 17.056 32.661 30.291 0.044539 56257 10635 3876.4
0.73 0.09 0.18 17.039 32.996 29.972 0.047002 32613 8491.4 4463.6
0.61 0.13 0.26 17.053 32.807 30.147 0.045932 45565 9549.9 8406.5
0.49 0.17 0.34 17.039 32.995 29.972 0.047001 32622 8491.2 8432.7
0.37 0.21 0.42 17.056 32.66 30.291 0.044538 56287 10635 16287
0.25 0.25 0.5 17.056 32.66 30.291 0.044538 56287 10635 19389
0.13 0.29 0.58 17.04 33.027 29.941 0.047469 31156 8315.1 13858
0.01 0.33 0.66 17.073 32.325 30.61 0.042512 87231 13462 37671




Figure 3: Pareto Frontier using the Proposed Hybrid Optimization
Model
The MATLAB program codes for solving the proposed
RD hybrid optimization model can automatically generate a
number of Pareto solutions and Pareto frontier based on the
given weights
1
,
2
, and
3
. By considering the trade-off
between three responses while changing the weights from 0.0
to 1.0, the proposed method can generate all the efficient
solutions in the entire region.
IV. CONCLUSION
Determining the optimal settings of control factors in order to
improve a product/process quality is often the challenge to
the manufacturing engineering, especially the pharmaceutical
industry. The problem can be solved efficiently by using the
robust design principle. In this study, the extreme vertices
designs are conducted because of the upper and lower
constraints on the control factors. Then, the statistical tool
RSM is used to perform the functional relationship between
the multiple quality characteristics of the microemulsion-
based hydrogel formulation and its input factors. By using
MATLAB software package, the full quartic response
functions are used with significant reliability. In addition, the
trade-off problem between the multiple conflicted responses
and the boundary specifications on the bias as well as the
standard deviation can be solved efficiently by using the
proposed RD hybrid model. For further extension, the
correlations between multiple quality characteristics of the
microemulsion-based hydrogel formulation can be
investigated. Moreover, the multiple responses can be
transformed into the same scale to consider the trade-off
between them.
ACKNOWLEDGEMENT
This research was supported by Basic Science Research
Program through the National Research Foundation of Korea
(NRF) funded by the Ministry of Education, Science and
Technology (20120683).
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Development of a Robust Design Hybrid Optimization Model
for Formulations of Microemulsion-based Hydrogel, 2014
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& Natural Science (BBENS), BBENS1006.
Le Tuan-Ho. Le Tuan-Ho is a PhD student at
the Department of Industrial & Management
Systems Engineering at Dong-A University,
Korea. He holds a Master of Electrical
Engineering from Hanoi University of
Science and Technology, Vietnam and
Bachelor of Electrical Engineering from
Danang University of Technology, Vietnam.
Before joining PhD program, he was a Lecturer at QuyNhon
University, Vietnam. His research interests are robust design,
tolerance design, pharmaceutical quality by design, neural network,
estimation, multi-objective optimization, and applied statistics.
Sangmun Shin. Sangmun Shin is an
Associate Professor at the Department of
Industrial &Management
SystemsEngineering,the head of Artificial-
intelligent Plant Integrated Design (APID)
Institute, and the Director of the Quality
EngineeringLaboratory at Dong-a University,
South Korea. He received his MS and PhDin
Industrial Engineering from the Clemson University, USA. His
researchinterests include quality engineering, robust and tolerance
designs,multi-objective optimization and pharmaceutical process
design. Hereceived his Career Development Research Award from
the Korea ResearchFoundation. He currently serves on the editorial
board of both InternationalJournal of Quality Engineering and
Technology and International Journal ofExperimental Design and
Process Optimization. He is a member of IIE andAlpha Pi Mu. He
has been registered by a biographical dictionary (Marquis Who's
Who in the World)from 2010.
Yonghee Lee. Yonghee Lee is the president
of Co-won LTD. He received his MS and
PhDin Industrial & Systems Engineering from
Dong-a University, Republic of Korea. He had
been worked in Instrument & Control
Division at Korea Atomic Energy Research
(KAERI) Institute for five years. His
researchinterests include quality and safety
engineering, nuclear safety review, human error, safety culture,
human factors suitability, workstation design, green logistics,
universal design and instrument & control human factors.
Seong Hoon Jeong. SeongHoonJeong is an
Assistant Professor at the College of
Pharmacy, Dongguk University, South
Korea. He received his PhD in Industrial
&Physical Pharmacy from Purdue University,
USA. After he worked forPfizer Global R&D
Center (previously Wyeth Research) as a
Senior Research Scientist, he joined the
College of Pharmacy, Pusan NationalUniversity as an Assistant
Professor. His research interests include design ofexperiment
regarding the pharmaceutical development, preformulation
andformulation development, and analytical method development.
He currentlyserves on the editorial board of the Journal of
Pharmaceutical Investigation.He is the member of Rho Chi Societh.
Sittichai Kaewkuekool. Sittichai
Kaewkuekool is Dean of Faculty of Industrial
Education and Technology and Associate
Professor at Department of Production
Technology, King Mongkuts University of
Technology Thonburi, Bangkok Thailand. He
received his MS in University of Miami,
Miami, FL. MS degree in Industrial
Engineering and PhDin Industrial Engineering from the Clemson
University, USA. His researchinterests include human factors
engineering, man-machine interface, and Logistics.