INTERNATIONAL UNIVERSITY SCIENTIFIC WRITING

ENGLISH DEPARTMENT Dr. Vu Hoa Ngan

HOMEWORK 2: ANALYZING AN INTRODUCTION SECTION

Instructions: Analyze the following samples of published introductions according to the Introduction
framework on p. 24. Highlight the language signals of the categories.
1.1. Establish the importance of your field 2. Previous and/or current research and
1.2. Provide background facts/information (possibly contributions
from research) 3.1. Locate a gap in the research
1.3. Define the terminology in the title/ key words 3.2. Describe the problem you will address
1.4. Present the problem area/ current research focus 3.3. Present a prediction to be tested
4. Describe the present paper

Article 1: Productivity Enhancement in a Small Scale Manufacturing Unit through Proposed Line Balancing and
Cellular Layout (Nallusamy, 2016)
Sen Sentence Description
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1 Lean is defined as a policy to achieve significant continuous development in 1.3 Define the
performance by eliminating all wastes and time in the total manufacturing terminology in the key
process. words
2 Lean manufacturing applications are used to make the manufacturing 1.1
industries to become competitive by means of eliminating wastes while
producing products and offering services.
3 Different lean tools like 5S, Kaizen, Poka Yoke, Kanban, JIT, etc have been 1.2
used during implementation of lean manufacturing in different types of
manufacturing organizations.
4 Lean manufacturing is a set of tools and techniques used for productivity 1.2
improvement, reduction of cycle time and continuous elimination of all
wastes in the production process.
5 Lean philosophy helps the manufacturing sector to reduce the lead time, 1.2
waste and to increase the customer satisfaction.
6 Hence lean can be explained as a culture to be followed rather than set of 1.3
tools to be developed and trained.
7 The objective of this article is to use different lean tools such as time study, 4, 3.2
Kanban, line balancing and cellular layout for improving the productivity by
reducing the material movement time and in turn by reducing the overall
production time in a small scale gas stove burner manufacturing industry of
Sai products located in Chennai.
8 The industry has developed a new production line for gas stove burner 2
assembly but it is not meeting the production target as line is not balanced.
9 The aim is to reduce the lead time of gas stove burner assembly line by at 3.3
least 10 % and increase the productivity by about 20 % by using lean
techniques and also confirm the process using Arena.

Article 2: A Review of Quantitative Risk–Benefit Methodologies for Assessing Drug Safety and Efficacy—Report
of the ISPORRisk–Benefit Management Working Group (Guo et al., 2010)
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1 In the past decade, over a dozen high‐profile brand‐name drugs, including 1.2
rofecoxib, troglitazone, cisapride, and cerivastatin, were withdrawn from the
market.
2 The US Food and Drug Administration (FDA) established a Drug Safety and 2
Risk Management Division, which is charged with evaluating the safety,
efficacy, and abuse potential of drugs, as well as risk management and risk
communication.

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3 In March 2005, the FDA issued risk management guidance for the 2
pharmaceutical industry, which included three separate guidelines:
Premarketing Risk Assessment, Development and Use of Risk Minimization
Action Plans, and Good Pharmacovigilance Practices and
Pharmacoepidemiologic Assessment
4 In 2007, Title IX of the FDA Amendments Act gave the FDA the authority to 2
require companies to develop and implement a risk evaluation and mitigation
strategy for specified prescription drugs.
5 In this era of renewed focus on drug safety, the FDA has called for more 1.2
creative approaches to conceptualizing, measuring, and applying risk–benefit
assessment (RBA) techniques to develop and improve a systematic RBA
approach throughout the life cycle of a pharmaceutical product.
6 Appropriate RBA can provide useful information for proactive intervention in 1.2
health‐care settings, which could save lives, reduce litigation, and lead to
improved patient safety, better health outcomes, and lower overall health‐care
costs.

7 In Europe, part of the mandate of the Committee for Medicinal Products for 1.2
Human Use (CHMP) is to assess risks and benefits of authorized medicines on
behalf of the European Medicines Agency (EMEA).
8 In 2007, the CHMP revised its guidance and included quantitative RBA in the 2
regulatory agenda with the publication of a report examining the potential
value of existing benefit–risk models and methods.
9 Although no specific method was recommended, several RBA features were 2
noted as being of value, including 1) all important benefits and medically
serious risks are identified; and 2) the risks and benefits are weighted
according to their relative importance and the strength of the evidence
available.
10 It was also decided that a comprehensive review of available quantitative 2
methods for RBA relevant to the CHMP was required to explore further
development of tailored methodologies.
11 The EMEA recently created the European Network of Centres for 1.2
Pharmacoepidemiology and Pharmacovigilance, which is in the process of
developing an algorithm to articulate safety and benefit profiles for
pharmaceutical products.

12 Regulatory agencies use various methods to discover rare toxic events. 1.4

13 These include review of data from randomized controlled clinical trials, 1.4
observational epidemiological studies (case‐control, cohort, and cross‐
sectional analyses), drug‐use surveys, automated databases linking drugs and
disease, spontaneous reporting (passive surveillance, such as the FDA's
MedWatch program), and established patient registries.
14 When a regulatory authority such as the FDA or the EMEA obtains information 1.4
about potentially significant drug toxicity, it thoroughly reviews the original
new drug application data that were used for the initial approval.
15 Concurrently, a formal analysis is initiated by reviewing all the spontaneous 3.1
reports available from the FDA Adverse Events Reporting System, the United
Kingdom's Yellow Card Scheme, and the World Health Organization's Uppsala
Monitoring Centre.
16 Additionally, the sponsor of a pharmaceutical product is required to review its 3.1
safety database and report directly to the regulators.
17 In some circumstances, further postmarketing studies are designed to answer 1.4
specific questions about toxicity.
18 In the process of reviewing risks and benefits, a regulatory authority typically 3.2
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seeks input from advisory committees that review safety and efficacy data and
make recommendations.
19 There is a structured process for convening the appropriate advisory 3.2
committee.
20 The authority prepares a set of questions involving product safety, efficacy, 4
study design, results interpretation, and risk–benefit profiles for committee
discussion.
21 After review of the advisory committee's recommendations, the authority 3.3, 3.2
determines a course of action, which may include changes to labeling, direct
correspondence to health professionals, or removal of the drug from the
market.

22 This traditional process does not produce an explicit, consistent, transparent, 3.1
and aggregate quantification of the risks and benefits and lacks clarity
pertaining to the role of specific factors in the recommendations.
23 Although some quantitative measures, such as quality‐adjusted life‐years 3.1
(QALYs) and number needed to treat (NNT), discussed later in this article, are
used by regulators, there is lack of standardized and validated quantitative
methodology.
24 Challenges to developing such a methodology include heterogeneity and 3.3
multiplicity of risks and benefits, uncertainty regarding attribution of risks and
benefits to a particular treatment, and the temporality and paucity of drug‐
exposure and outcome data.
25 Furthermore, the traditional process does not allow for systematic 3.1
reassessment of risks and benefits over time.
26 Although an innovative drug may initially possess advantageous risk–benefit 3.3
ratios versus older drugs, these ratios often change over time, as occurred, for
example, with COX‐II inhibitors.

27 Although none of the major regulatory agencies has a clear benchmark for 3.3
what constitutes an acceptable level of risk, nevertheless, the pharmaceutical
industry is functioning in an era of increased risk assessment, which requires
proactive drug‐safety analysis and additional commitment to safety.
28 Several dozen risk‐management programs or registries have been established 4
by major pharmaceutical companies in the United States, including iPLEDGE®
to prevent exposure to isotretinoin during pregnancy, the clozapine patient
registry to prevent agranulocytosis, an alosetron prescribing program for
reducing the risk of severe gastrointestinal adverse events, and the STEPS®
program to prevent exposure to thalidomide during pregnancy.
29 Moreover, various RBA methods have been utilized for clinical decision‐ 1.1
making in the following drug categories: oral contraceptives, antipsychotics,
antihyperlipidemia medications, cancer chemotherapy, iron‐chelation, and
antihypertensives, among others.

30 Our study objectives are to review and compare published quantitative RBA 3.2
methodologies employed by regulatory agencies and/or the pharmaceutical
industry.

31 These comparisons may help disclose unique characteristics of the RBA 3.3
techniques that may be more applicable to a specific drug evaluation scenario
or a specific therapeutic indication.
32 This useful information can be used to inform public and private RBA 3.3
designers.

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Article 3: Applications of Process Industrial Engineering in Food Industry (Vibhute et al., 2019)

Sen Literature review Sentence Description

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1 In the Digitalization era, simulation covers a primary role in every field 1.1
(finance, management, and manufacturing) and at all levels (strategic, tactical,
and operational).
2 In particular, the industrial engineering field, to which manufacturing belongs 1.1
to, is a very flourished land for simulation development, taking advantage of
the recent deployment of Cyber-Physical Systems (CPS) (Negri, Fumagalli and
Macchi, 2017).
3 The importance of simulation in industrial engineering was already highlighted 1.1
by the first pioneers in simulation research studies, since the 80s: it was
considered among the first top three methodologies used by industrial
engineers, managers and operations researchers (Banks, 1998).
4 Moreover, simulation is ranked as the second most used methodologies for the 1.1
OM (Operations Management) field of studies (Shafer and Smunt, 2004), only
after optimisation.
5 This view of simulation as central in company and research is demonstrated by 1.2
many research papers and empirical studies, whose number has been
continuously increased since the first conceptualisation of possible uses of
simulation in IE, in the mid of 80s.
6 To figure out the amount of works done, some numbers are here provided: 1.2
from 2002 to 2013, the searching process with the keywords “simulation” plus
“manufacturing” finds out about 3000 published papers, whereas the overall
research process with other keywords, such as “industrial engineering” or
“operations”, results in around 12000 published papers in the same periods
(Negahban and Smith, 2014).
7 This results are impressive and are confirmed by another survey made in the 1.2
same year (Mourtzis, Doukas and Bernidaki, 2014), for which the final detailed
graph is reported.
8 Many definitions of simulation consider computer involvement as a consistent 1.3
part of the definition itself: “Simulation modelling and analysis is the process of
creating and experimenting with a computerised mathematical model of a
physical system” (Chung, 2004).
9 However, this definition is narrowed because it limits the application of 1.3
simulation with a computerised system: the success of simulation is strictly
related to computers advent (Smith, 2003), but the concept of simulation exists
independently.
10 A simple but meaningful definition is provided by (Maria, 1997): “Simulation is 1.3
a way of evaluating a proposed system for various parameters within a specific
period of time”.
11 A complete definition, and maybe the most notable, is: “Simulation is the 1.3
imitation of the operation of the real-world process or system over time”
(Banks, 1998).
12 The importance of these two statements is confirmed by the continuous 1.1
recalling of them into recently published papers, and so they are taken as a
reference to analyse simulation-related articles in this work.
13 The importance of simulation in IE is evident, but which are the main 1.4
applications within this field?
14 The next sections try to answer this question, making a preliminary review of 1.4 , 4
the most cited surveys in the field of IE: section 2 deals with the literature
analysis of published survey/reviews, which shows up two important trends in
the use of simulation; section 3 presents an elaboration of the literature
review, concerning a distinction between applications used in different
lifecycle phases of the industrial systems and a classification of the applications
according to a three dimensional framework called 3D-SAM (3 Dimensional –
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Simulation Applications Model); section 4 states some conclusions about
integrated simulation model for DSS (Decision Support System) in CPS; finally
future works and improvements are described in section 5.

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