NEED FOR RESEARCH Research is a systemic process of collecting and analyzing information to increase the understanding of the phenomenon under study. It strengthens pharmacist-provided services, builds the evidence base for developing and commissioning new services, improves patient care and contributes to health service knowledge. Phase I studies: Are done on healthy volunteers who agree to take the study drug to help the doctors determine how safe the drug is and if there are any side effects. Usually a small number of subjects (20-100) participate in Phase I studies. Approximately 70% of new drugs will pass this phase. Phase II studies: Measure the effect of the new drug in patients with the disease or disorder to be treated. The main purpose is to determine safety and effectiveness of the new drug. Usually several hundred patients participate. These studies are usually “Double-blinded, randomized and controlled”. Phase III studies: also use patients with the disorder to be treated by the new drug. These studies are done to gain a more thorough understanding of the effectiveness, benefits and side effects of the study drug.  NEED FOR DESIGN OF EXPERIMENTS Design of experiments (DOE) is defined as a branch of applied statistics that deals with planning, conducting, analyzing, and interpreting controlled tests to evaluate the factors that control the value of a parameter or group of parameters. DOE is a powerful data collection and analysis tool that can be used in a variety of experimental situations. 1. PRE-EXPERIMENTAL DESIGN In pre-experimental research design, either a group or various dependent groups are observed for the effect of the application of an independent variable which is presumed to cause change. It is the simplest form of experimental research design and is treated with no control group 2. TRUE EXPERIMENTAL DESIGN The true experimental research design relies on statistical analysis to approve or disprove a hypothesis. It is the most accurate type of experimental design and may be carried out with or without a pretest on at least 2 randomly assigned dependent subjects. The true experimental research design must contain a control group, a variable that can be manipulated by the researcher, and the distribution must be random. 3. QUASI EXPERIMENTAL DESIGN The word "quasi" means partial, half, or pseudo. Therefore, the quasi-experimental research bearing a resemblance to the true experimental research, but not the same.  In quasi-experiments, the participants are not randomly assigned, and as such, they are used in settings where randomization is difficult or impossible. This is very common in educational research, where administrators are unwilling to allow the random selection of students for experimental samples. PLAGIARISM The word Plagiarism is derived from the Latin word Plagiarius, which means abducting, kidnapping, seducing, or plundering.

1. BIOSTATISTICS AND RESEARCH METHODOLOGY
Unit-3: introduction to research
PRESENTED BY
Gokara Madhuri
B. Pharmacy IV Year
UNDER THE GUIDANCE OF
Gangu Sreelatha M.Pharm., (Ph.D)
Assistant Professor
CMR College of Pharmacy, Hyderabad.
email: sreelatha1801@gmail.com

2. NEED FOR RESEARCH
• Research is a systemic process of collecting and analyzing information to increase the understanding of
the phenomenon under study.
• It strengthens pharmacist-provided services, builds the evidence base for developing and commissioning
new services, improves patient care and contributes to health service knowledge.
• Research studies are designed to test the effect of a medication or treatment in a group of volunteers,
measure a drug’s ability to treat the medical condition, monitor the drug’s safety, and possible side
effects.
• Pharmaceutical companies may sponsor research studies by providing funding and designing the
protocol, which is a set of detailed guidelines. Trained doctors, nurses and researchers conduct research
studies.
• Research in pharmacy also includes formulation of dosage forms of medicaments and study of their
stability, methods of assay, and standardization.
• The Food and Drug Administration (FDA) is the government agency that is responsible for research
studies. It regulates the conduct of research studies, enforces the laws on the use of drugs, and must
approve all new drugs before they are available to the general public.
• The purpose of research is to discover answers to questions through the application of scientific
procedures. The main aim of research is to find out the truth which is unveiled and which has not been
discovered yet.

3. • There are three steps in doing research studies. All three of these steps must be successfully completed
and all results known before a new drug can be approved for public use.
• Phase I studies: Are done on healthy volunteers who agree to take the study drug to help the doctors
determine how safe the drug is and if there are any side effects. Usually a small number of subjects (20-
100) participate in Phase I studies. Approximately 70% of new drugs will pass this phase.
• Phase II studies: Measure the effect of the new drug in patients with the disease or disorder to be
treated. The main purpose is to determine safety and effectiveness of the new drug. Usually several
hundred patients participate. These studies are usually “Double-blinded, randomized and controlled”.
• In controlled studies, the effect of the active drug is compared to the effect of a placebo (inactive or
“sugar” pill). In double blinded studies neither the investigator nor the study subject knows who is
getting active drug and who is receiving placebo medication. One third of studied drugs complete both
Phase I and II.
• Phase III studies: also use patients with the disorder to be treated by the new drug. These studies are
done to gain a more thorough understanding of the effectiveness, benefits and side effects of the study
drug.
• Of the new drugs that enter Phase III studies, 70 to 90% of drugs successfully complete this phase. If the
results show a good effect and safety profile, the company will submit the data and request FDA
approval for marketing the drug.

4. • Participating in research is like a daily visit to a clinic or hospital, but even with more personal attention.
Preliminary screening for the study is done by phone. Basic criteria of age,symptoms and medical
history are reviewed and details of study are discussed. If the caller seems to qualify or interested they
asked to come for screening.
• After reviewing the information gathered over the phone, the informed consent form is signed by the
subject and the supervising physician. A copy is given to the subject. A physical exam, blood, and other
tests may be done. At the end of the screening period the patient returns to the clinic for the
randomization visit. If the patient’s baseline information shows that they qualify for the study, they are
then randomized (usually by computer) to receive placebo or active drug.
• During the treatment period the subjects are taking the study medication on a regular basis, and
recording their symptoms. At the end of the treatment period, medication use and symptoms are
reviewed and recorded. After completion of the treatment period, many studies have a follow up period
to assess how symptoms and possible side effects have changed.
• Risks vary from study to study. Researchers expect certain results but since the treatment is new and is
still being studied it is impossible to say exactly what the risks may be. If a side effect or adverse event
does occur, it is generally temporary and will go away as soon as the treatment is stopped.
• Participating in a research study helps yourself, as you might have a beneficial effect from the study drug
and to help others in gathering information during studies and making new treatments available.

5. • Design of experiments (DOE) is defined as a branch of applied statistics that deals with planning,
conducting, analyzing, and interpreting controlled tests to evaluate the factors that control the value of a
parameter or group of parameters.
• DOE is a powerful data collection and analysis tool that can be used in a variety of experimental
situations.
• It allows for multiple input factors to be manipulated, determining their effect on a desired output
(response). By manipulating multiple inputs at the same time, DOE can identify important interactions
that may be missed when experimenting with one factor at a time. All possible combinations can be
investigated (full factorial) or only a portion of the possible combinations (fractional factorial).
• Many of the current statistical responses to designed experiments originate from the work of R. A. Fisher
in the early part of the 20th century. Fisher demonstrated how taking the time to seriously consider the
design and execution of an experiment before trying it helped avoid frequently encountered problems in
analysis. Key concepts in creating a designed experiment include blocking, randomization, and
replication.
• Blocking: When randomizing a factor is impossible or too costly, blocking lets you restrict
randomization by carrying out all of the trials with one setting of the factor and then all the trials with the
other setting.
NEED FOR DESIGN OF EXPERIMENTS

6. • Randomization: Refers to the order in which the trials of an experiment are performed. A randomized
sequence helps eliminate effects of unknown or uncontrolled variables.
• Replication: Repetition of a complete experimental treatment, including the setup.
Experimental design process
Define problems
Determine
objectives
Determine
Responses and
factors
Design
experiments
Conduct
experiment and
collect data
Analyze data Interpret results
Verify predicted
results
Additional
Experiments as
required

7. EXPERIMENTAL DESIGN TECHNIQUES
• Experimental design describes an outline or framework of an experiment to make the study efficacious
by obtaining the true results in effective time period.
Types of
experimenta
l designs
Pre-
experimenta
l design
Before and
after without
control
design
After only
with control
design
Before and
after with
control
design
Quasi
experimenta
l design
Non-
equivalent
groups
design
Regression
discontinuity
Natural
experiments
True
experimenta
l design
The posttest
only control
group design
The pretest
and posttest
control
group design
Soloman
four group
design
Randomised
block design
Cross over
design
Factorial
design

8. 1. PRE-EXPERIMENTAL DESIGN
• In pre-experimental research design, either a group or various dependent groups are observed for the
effect of the application of an independent variable which is presumed to cause change.
• It is the simplest form of experimental research design and is treated with no control group.
• Although very practical, experimental research is lacking in several areas of the true-experimental
criteria. The pre-experimental research design is further divided into three types.
Before and after without control design:
• In this design a single group or area is selected and the dependent variable is measured before and after
the starting of the treatment. The complexity of the design is that the treatment can be effected in the
presence of extraneous variations.
• The effect of the treatment would be equal to the level of phenomenon(Y) after the treatment minus the
level of the phenomenon(X)before the treatment.
• Represented as treatment effect = Y-X.
After-only with control design:
• In this design are two groups or areas, test area and control area are chosen and the treatment starts with
the test area only.
• The dependent variable is then measured in both the areas at the same time. Treatment impact is assessed
by subtracting the value of the dependent variable in the control area from its value in the test area.

9. • In other words the basic assumption in such a design is that the two areas are identical with respect to
phenomenon considered.
• If this assumption is not true, there is the possibility of extraneous variation entering into the treatment
effect.
• In this respect the design is superior to before and after without control design.
Before and after with control design:
• This design involves the two areas with measured dependent variables in both the areas for same time
period before the treatment.
• The treatment is then introduced into the test area only, and the dependent variable is measured in both
for an identical time-period after the introduction of the treatment.
• The treatment effect is determined by subtracting the change in the dependent variable in the control
area from the change in the dependent variable in test area.
• This design is shown in this way treatment effect = Y-Z
• This design is superior to the above two designs for simple reason that it avoids extraneous variation
resulting both from the passage of time and from non-comaparatability of the test and control areas.
• But at times due to lack of historical data, time or a comparatable control area, we should prefer to
select one of the first two informal designs stated above

10. 2. TRUE EXPERIMENTAL DESIGN
• The true experimental research design relies on statistical analysis to approve or disprove a hypothesis.
It is the most accurate type of experimental design and may be carried out with or without a pretest on
at least 2 randomly assigned dependent subjects.
• The true experimental research design must contain a control group, a variable that can be manipulated
by the researcher, and the distribution must be random.
• Example: To run a true experiment, you randomly assign half the patients in a mental health clinic to
receive the new treatment. The other half—the control group—receives the standard course of
treatment for depression.
• Every few months, patients fill out a sheet describing their symptoms to see if the new treatment
produces significantly better (or worse) effects than the standard one. The classification of true
experimental design include:
The post test-only Control Group Design:
• In this design, subjects are randomly selected and assigned to the 2 groups (control and experimental),
and only the experimental group is treated. After close observation, both groups are post-tested, and a
conclusion is drawn from the difference between these groups.
The pre test-posttest Control Group Design:
• For this control group design, subjects are randomly assigned to the 2 groups, both are presented, but
only the experimental group is treated. After close observation, both groups are post-tested to measure
the degree of change in each group.

11. Solomon four-group Design: This is the combination of the pretest-only and the pretest-posttest control
groups. In this case, the randomly selected subjects are placed into 4 groups.
• The first two of these groups are tested using the posttest-only method, while the other two are tested
using the pretest-posttest method.
Randomized Block Design:
• The randomized block design is preferred in the case when the researcher is clear about the distinct
difference among the group of objects. In this design, the experimental units are classified into
subgroups of similar categories. Those groups are randomly assigned to the group of treatment. The
blocks are classified in such a way in which the variability within each block should be less than the
variability among the blocks. This block design is quite efficient as it reduces the variability and
produces a better estimation.
• Example:
• In a drug testing experiment, the researcher believes that age is the most significant factor. So he divides
the units according to the age groups such as
• Under 15 years old
• 15 – 35 years old
• 36 – 55 years old
• Over 55 years old

12. Cross over design:
• In this design subjects are exposed to more than one treatment, where subjects are randomly assigned
to different orders of treatment.
• It is also known as ‘’repeat measures design’’.
• This design is more efficient in establishing the highest possible similarity among subjects exposed to
different conditions, where groups compared obviously have equal distribution of characteristics.
Factorial design:
• Factorial designs are used to determine the variation effects where more than one factor vary in the
experiments. This design is generally used to deal with large number of factors.
• Factorial designs can be of two types
• Two factor factorial design
• Multifactor factorial design
• In case Two factor factorial design, the effects of varying two factors on the dependent variable are
involved. Simple factorial design may either be a 2x2 or it may be 3x5 or 5x4.
• Where as multifactorial design is applied when an experiment is done with more than two factors, we
use complex factorial designs

13. 3. QUASI EXPERIMENTAL DESIGN
• The word "quasi" means partial, half, or pseudo. Therefore, the quasi-experimental research bearing a
resemblance to the true experimental research, but not the same. In quasi-experiments, the participants
are not randomly assigned, and as such, they are used in settings where randomization is difficult or
impossible.
• This is very common in educational research, where administrators are unwilling to allow the random
selection of students for experimental samples.
• Some examples of quasi-experimental research design include; the time series, no equivalent control
group design, and the counterbalanced design.
Nonequivalent groups design
• In nonequivalent group design, the researcher chooses existing groups that appear similar, but where
only one of the groups experiences the treatment.
• In a true experiment with random assignment, the control and treatment groups are considered
equivalent in every way other than the treatment. But in a quasi-experiment where the groups are not
random, they may differ in other ways—they are nonequivalent groups.
• This is the most common type of quasi-experimental design.
• When using this kind of design, researchers try to account for any confounding variables by controlling
for them in their analysis or by choosing groups that are as similar as possible

14. • Example: Nonequivalent groups design.You hypothesize that a new after-school program will lead to
higher grades. You choose two similar groups of children who attend different schools, one of which
implements the new program while the other does not.
• By comparing the children who attend the program with those who do not, you can find out whether it
has an impact on grades.
Regression discontinuity
• Many potential treatments that researchers wish to study are designed around an essentially arbitrary
cutoff, where those above the threshold receive the treatment and those below it do not.
• Near this threshold, the differences between the two groups are often so minimal as to be nearly
nonexistent. Therefore, researchers can use individuals just below the threshold as a control group and
those just above as a treatment group.
• Example: Regression discontinuity some high schools in the United States are set aside for high-
achieving students, who must exceed a certain score on a test to be allowed to attend. Those who pass
this test most likely differ systematically from those who do not.
• However, since the exact cutoff score is arbitrary, the students near the threshold those who just barely
pass the exam and those who fail by a very small margin tend to be very similar, with the small
differences in their scores mostly due to random chance. You can therefore conclude that any outcome
differences must come from the school they attended.
• To test the impact of attending a selective school, you can study the long-term outcomes of these two
groups of students (those who barely passed and those who barely failed).

15. Natural experiments:
• In both laboratory and field experiments, researchers normally control which group the
subjects are assigned to. In a natural experiment, an external event or situation (“nature”)
results in the random or random-like assignment of subjects to the treatment group.
• Even though some use random assignments, natural experiments are not considered to be true
experiments because they are observational in nature.
• Although the researchers have no control over the independent variable, they can exploit this
event after the fact to study the effect of the treatment.
• Example: Natural experiment the Oregon health study is one of the most famous natural
experiments. In 2008, the state of Oregon decided to expand enrollment in Medicaid,
America’s low-income public health insurance program, to more low-income adults.
• However, as they could not afford to cover everyone who they deemed eligible for the
program, they instead allocated spots in the program based on a random lottery.
• Researchers were able to study the impact of the program by using the enrolled individuals as
a randomly assigned treatment group, and the others who were eligible but did not succeed in
the lottery as a control group.

16. PLAGIARISM
• The word Plagiarism is derived from the Latin word Plagiarius, which means abducting, kidnapping,
seducing, or plundering.
• In Merriam webster online dictionary- To plagiarize means to use the words or ideas of another person
as if they were your own words or ideas or to steal and pass off the ideas or words of another as one’s
own or use another’s production without crediting source.
• According to American association of university professors Plagiarism taking over the ideas methods
or written words of another without acknowledgement and with the intention that may be taken as the
work of the deceiver.
TYPES OF PLAGIARISM:
1. Complete plagiarism: Submit another authors in your name
2. Source based plagiarism(Misattribution, Misleading citation, Fabrication, Falsification):This type of
plagiarism refers to instances when misleading sources are involved.
3. Direct plagiarism(Verbatim, Hired Plagiarism): Copy text from another document source word to
word.
4. Self or Auto plagiarism(Duplication ,Reuse,Repititive Research):Reuse your major part of your own
work without attribution.

17. 5. Paraphrasing plagiarism(Intellectual theft):Rewrite the text or ideas in your own words but keep
its meaning. Substantially changes the structure of the text.
6. Mosaic plagiarism(Patch work Plagiarism):Copy from a source text and then deleting some words,
altering grammatical structures or plugging in one-for-one synonym substitutes.
7. Accidental plagiarism: When a writer attempts or intends to write in his/her own words but out of
ignorance, sloppiness or carelessness fails to distinguish quote from para phrase or fails to cite and
document properly.
8. Inaccurate authorship plagiarism(Unethical collaboration, Misleading attribution):Inaccurate
authorship plagiarism occurs
9. Duplicate Publication: Submitting the same data,idea to more than one journal without informing
editor. Unethical practice even if the order of authorship has changed.
10. Insufficient acknowledgement: Nothing the original source of only part of what is borrowed or
failing to cite the source material in such a way that a reader will know what is original and what
borrowed.
11. Global Plagiarism: Complete form of cheating you take someone else whole work and submit it to
your professor as your own.
12. Minimalistic plagiarism: Authoring someone else ideas in your own words/ in a different flow.

18. 13. Outline plagiarism: The offence takes place when you use the same outline as another author’s
content.
14. Replication (Another submission violation plagiarism): Submission of a paper to multiple
publications, resulting in the same manuscript being published more than once unethical
infraction.
15. Incremental plagiarism: It means inserting quotes, passages from other works into your work
without properly citing the original source.
16. Graphic plagiarism: It means the unauthorized use or close imitation of existing artwork and the
representation of it as one's own original work.