INTERNATIONAL UNIVERSITY SCIENTIFIC WRITING

ENGLISH DEPARTMENT Dr. Vu Hoa Ngan

Student name: Trầ n Tiến Đạ t

Student ID: IELSIU20282
Group: 03

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 contributions
1.2. Provide background facts/information (possibly from 3.1. Locate a gap in the research
research) 3.2. Describe the problem you will address
1.3. Define the terminology in the title/ key words 3.3. Present a prediction to be tested
1.4. Present the problem area/ current research focus 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 terminology
performance by eliminating all wastes and time in the total manufacturing process. in the key words
2 Lean manufacturing applications are used to make the manufacturing industries to 1.2. Provide background
become competitive by means of eliminating wastes while producing products and facts/information (possibly
offering services. from research)
3 Different lean tools like 5S, Kaizen, Poka Yoke, Kanban, JIT, etc have been used 1.2. Provide background
during implementation of lean manufacturing in different types of manufacturing facts/information (possibly
organizations. from research)
4 Lean manufacturing is a set of tools and techniques used for productivity 1.3 Define the terminology
improvement, reduction of cycle time and continuous elimination of all wastes in the in the key words
production process.
5 Lean philosophy helps the manufacturing sector to reduce the lead time, waste and 1.2. Provide background
to increase the customer satisfaction. facts/information (possibly
from research)
6 Hence lean can be explained as a culture to be followed rather than set of tools to be 1.3 Define the terminology
developed and trained. in the key words
1.2. Provide background
facts/information (possibly
from research)
7 The objective of this article is to use different lean tools such as time study, Kanban, 1.4. Present the problem
line balancing and cellular layout for improving the productivity by reducing the area/ current research focus
material movement time and in turn by reducing the overall production time in a 4. Describe the present
small scale gas stove burner manufacturing industry of Sai products located in paper
Chennai.
8 The industry has developed a new production line for gas stove burner assembly but 1.4. Present the problem
it is not meeting the production target as line is not balanced. area/ current research focus
3.1. Locate a gap in the
research
9 The aim is to reduce the lead time of gas stove burner assembly line by at least 10 % 1.4. Present the problem
and increase the productivity by about 20 % by using lean techniques and also area/ current research focus
confirm the process using Arena. 4. Describe the present
paper

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 rofecoxib, 1.2. Provide background
troglitazone, cisapride, and cerivastatin, were withdrawn from the market. facts/information
(possibly from research)
2 The US Food and Drug Administration (FDA) established a Drug Safety and Risk 1.2. Provide background
Management Division, which is charged with evaluating the safety, efficacy, and abuse facts/information
potential of drugs, as well as risk management and risk communication. (possibly from research)
3 In March 2005, the FDA issued risk management guidance for the pharmaceutical 1.2. Provide background
industry, which included three separate guidelines: Premarketing Risk Assessment, facts/information
Development and Use of Risk Minimization Action Plans, and Good Pharmacovigilance (possibly from research) &
Practices and Pharmacoepidemiologic Assessment 2. Previous and/or current
research and
contributions
4 In 2007, Title IX of the FDA Amendments Act gave the FDA the authority to require 1.2. Provide background
companies to develop and implement a risk evaluation and mitigation strategy for facts/information
specified prescription drugs. (possibly from research) &
2. Previous and/or current
research and
contributions

5 In this era of renewed focus on drug safety, the FDA has called for more creative 1.2. Provide background
approaches to conceptualizing, measuring, and applying risk–benefit assessment facts/information
(RBA) techniques to develop and improve a systematic RBA approach throughout the (possibly from research)
life cycle of a pharmaceutical product.
6 Appropriate RBA can provide useful information for proactive intervention in 1.2. Provide background
health‐care settings, which could save lives, reduce litigation, and lead to facts/information
improved patient safety, better health outcomes, and lower overall health‐care (possibly from research) &
costs. 1.1. Establish the
importance of your field

7 In Europe, part of the mandate of the Committee for Medicinal Products for Human Use 1.2. Provide background
(CHMP) is to assess risks and benefits of authorized medicines on behalf of the facts/information
European Medicines Agency (EMEA). (possibly from research)
8 In 2007, the CHMP revised its guidance and included quantitative RBA in the 1.2. Provide background
regulatory agenda with the publication of a report examining the potential value of facts/information
existing benefit–risk models and methods. (possibly from research)
9 Although no specific method was recommended, several RBA features were noted as 1.4. Present the problem
being of value, including 1) all important benefits and medically serious risks are area/ current research
identified; and 2) the risks and benefits are weighted according to their relative focus
importance and the strength of the evidence available.

10 It was also decided that a comprehensive review of available quantitative methods for 1.1. Establish the
RBA relevant to the CHMP was required to explore further development of tailored importance of your field
methodologies.
11 The EMEA recently created the European Network of Centres for 1.2. Provide background
Pharmacoepidemiology and Pharmacovigilance, which is in the process of facts/information
developing an algorithm to articulate safety and benefit profiles for (possibly from research)
pharmaceutical products.

12 Regulatory agencies use various methods to discover rare toxic events. 1.2. Provide background
facts/information
(possibly from research)
13 These include review of data from randomized controlled clinical trials, observational 1.2. Provide background
epidemiological studies (case‐control, cohort, and cross‐sectional analyses), drug‐use facts/information
surveys, automated databases linking drugs and disease, spontaneous reporting (possibly from research)
(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 about 1.2. Provide background
potentially significant drug toxicity, it thoroughly reviews the original new drug facts/information
application data that were used for the initial approval. (possibly from research)
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15 Concurrently, a formal analysis is initiated by reviewing all the spontaneous reports 1.2. Provide background
available from the FDA Adverse Events Reporting System, the United Kingdom's facts/information
Yellow Card Scheme, and the World Health Organization's Uppsala Monitoring Centre. (possibly from research) &
2. Previous and/or current
research and
contributions
16 Additionally, the sponsor of a pharmaceutical product is required to review its safety 1.4. Present the problem
database and report directly to the regulators. area/ current research
focus
17 In some circumstances, further postmarketing studies are designed to answer specific 1.2. Provide background
questions about toxicity. facts/information
(possibly from research)
18 In the process of reviewing risks and benefits, a regulatory authority typically seeks 2. Previous and/or current
input from advisory committees that review safety and efficacy data and make research and
recommendations. contributions
19 There is a structured process for convening the appropriate advisory committee. 1.2. Provide background
facts/information
(possibly from research)
20 The authority prepares a set of questions involving product safety, efficacy, study 1.2. Provide background
design, results interpretation, and risk–benefit profiles for committee discussion. facts/information
(possibly from research)
21 After review of the advisory committee's recommendations, the authority 1.2. Provide background
determines a course of action, which may include changes to labeling, direct facts/information
correspondence to health professionals, or removal of the drug from the (possibly from research)
market.

22 This traditional process does not produce an explicit, consistent, transparent, and 3.1. Locate a gap in the
aggregate quantification of the risks and benefits and lacks clarity pertaining to the research
role of specific factors in the recommendations.
23 Although some quantitative measures, such as quality‐adjusted life‐years (QALYs) and 3.1. Locate a gap in the
number needed to treat (NNT), discussed later in this article, are used by regulators, research
there is lack of standardized and validated quantitative methodology.
24 Challenges to developing such a methodology include heterogeneity and multiplicity of 3.2. Describe the problem
risks and benefits, uncertainty regarding attribution of risks and benefits to a you will address
particular treatment, and the temporality and paucity of drug‐exposure and outcome
data.
25 Furthermore, the traditional process does not allow for systematic reassessment of 3.1. Locate a gap in the
risks and benefits over time. research
26 Although an innovative drug may initially possess advantageous risk–benefit 3.1. Locate a gap in the
ratios versus older drugs, these ratios often change over time, as occurred, for research
example, with COX‐II inhibitors.

27 Although none of the major regulatory agencies has a clear benchmark for what 1.2. Provide background
constitutes an acceptable level of risk, nevertheless, the pharmaceutical industry is facts/information
functioning in an era of increased risk assessment, which requires proactive drug‐ (possibly from research)
safety analysis and additional commitment to safety.
28 Several dozen risk‐management programs or registries have been established by 1.2. Provide background
major pharmaceutical companies in the United States, including iPLEDGE® to prevent facts/information
exposure to isotretinoin during pregnancy, the clozapine patient registry to prevent (possibly from research)
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‐ 1.2. Provide background
making in the following drug categories: oral contraceptives, antipsychotics, facts/information
antihyperlipidemia medications, cancer chemotherapy, iron‐chelation, and (possibly from research)
antihypertensives, among others.

30 Our study objectives are to review and compare published quantitative RBA 3.2. Describe the problem

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methodologies employed by regulatory agencies and/or the pharmaceutical you will address
industry.

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

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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 (finance, 1.1. Establish the
management, and manufacturing) and at all levels (strategic, tactical, and operational). importance of your field
2 In particular, the industrial engineering field, to which manufacturing belongs to, is a 1.1. Establish the
very flourished land for simulation development, taking advantage of the recent importance of your field
deployment of Cyber-Physical Systems (CPS) (Negri, Fumagalli and Macchi, 2017). & 1.3. Define the
terminology in the title/
key words
3 The importance of simulation in industrial engineering was already highlighted by the 1.1. Establish the
first pioneers in simulation research studies, since the 80s: it was considered among importance of your field
the first top three methodologies used by industrial engineers, managers and & 2. Previous and/or
operations researchers (Banks, 1998). current research and
contributions
4 Moreover, simulation is ranked as the second most used methodologies for the OM 1.1. Establish the
(Operations Management) field of studies (Shafer and Smunt, 2004), only after importance of your field
optimisation.
5 This view of simulation as central in company and research is demonstrated by many 2. Previous and/or
research papers and empirical studies, whose number has been continuously increased current research and
since the first conceptualisation of possible uses of simulation in IE, in the mid of 80s. contributions
6 To figure out the amount of works done, some numbers are here provided: from 2002 2. Previous and/or
to 2013, the searching process with the keywords “simulation” plus “manufacturing” current research and
finds out about 3000 published papers, whereas the overall research process with contributions
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 same 2. Previous and/or
year (Mourtzis, Doukas and Bernidaki, 2014), for which the final detailed graph is current research and
reported. contributions
8 Many definitions of simulation consider computer involvement as a consistent part of 1.3. Define the
the definition itself: “Simulation modelling and analysis is the process of creating and terminology in the title/
experimenting with a computerised mathematical model of a physical system” (Chung, key words
2004).
9 However, this definition is narrowed because it limits the application of simulation 1.2. Provide background
with a computerised system: the success of simulation is strictly related to computers facts/information
advent (Smith, 2003), but the concept of simulation exists independently. (possibly from research)
10 A simple but meaningful definition is provided by (Maria, 1997): “Simulation is a way 1.3. Define the
of evaluating a proposed system for various parameters within a specific period of terminology in the title/
time”. key words
11 A complete definition, and maybe the most notable, is: “Simulation is the imitation of 1.3. Define the
the operation of the real-world process or system over time” (Banks, 1998). terminology in the title/
key words
12 The importance of these two statements is confirmed by the continuous recalling of 1.2. Provide background
them into recently published papers, and so they are taken as a reference to analyse facts/information
simulation-related articles in this work. (possibly from research)
13 The importance of simulation in IE is evident, but which are the main applications 1.4. Present the problem
within this field? area/ current research
focus

14 The next sections try to answer this question, making a preliminary review of the most 1.4. Present the problem
cited surveys in the field of IE: section 2 deals with the literature analysis of published area/ current research
survey/reviews, which shows up two important trends in the use of simulation; focus
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 – 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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