Introduction to

Pharmaceutical Statistics

Statistics
Statistics is the science of collection, organization, presentation,
analysis and interpretation of data.

Statistics is a set of concepts, rules, and procedures that help us to:

– organize numerical information in the form of tables, graphs, and
charts;
– understand statistical techniques underlying decisions that affect
our lives and well-being; and
– make informed decisions.
 Biostatistics
Application of statistical technique to scientific research in health-
related fields, including, medicine, pharmacy, biology, epidemiology
and public health and the development of new tools to study these area.

Application of Biostatistics

• In medical science
– Evaluate effectiveness of a new drug
– Compare the action of different types of drugs
– Find relation between disease and risk factor
– Analyze symptom and disease
– Define range or limit in biological parameters
– Set a range in different lab test
 Application of Biostatistics

• In Epidemiology and Public Health

– Role of risk factors are statistically tested
e.g. smocking causes cancer, deficiencies of Iodine cause goiter.
– Find out the emergence of infectious disease
e.g. severity of AIDS in human, evaluation of psychological health etc.
– For social welfare. e.g. family planning
– Find out the total social health condition.

Application of Biostatistics
• In pharmaceutical science
– In quality control of Pharmaceutical products
– In validation process
– To design experiment for study
– To evaluate the efficacy of the process
– To check the productivity of the equipments
– In planning area
 Population
• A population is a complete set
of individuals, objects or
measurements having some
common characteristics.
• It includes all the elements of
a set of data.

Sample
• A sample is a subset or part of the
population selected to represent the
population
• It consists of one or more
observations from the population.
• Example:
Population: paracetamol tablet
batch contains 100K tablets.
Sample: 20 tablets randomly taken
from each batch for test of
dissolution.
 Element

• Element (similar unit of analysis): This is the unit about which

information is collected and it provides the basis of analysis. In
survey research, elements are people or certain types of people.

Sample Surveys
The total count of all units of the population for a certain characteristic is
known as complete enumeration, also termed as census survey.

In statistics, survey sampling describes the process of selecting a sample

of elements from a target population to conduct a survey.

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Advantages of sample surveys over census surveys

▪ Get information about large populations

▪ Less costs
▪ Less field time
▪ More accuracy i.e. Can Do A Better Job of Data Collection
▪ When it’s impossible to study the whole population

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Classification of Sampling
The sampling procedures that are commonly used may be classified in to TWO
categories:
1. Probability Sampling
This is the method of selecting samples according to certain laws of probability in
which each unit in the population has some definite probability of being selected in
the sample.

2. Non-probability Sampling
This is the method of selecting samples, in which the choice of selection of
sampling units depends entirely on the judgment of the sampler.

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Types of Non-Probability Sampling

1. Convenient (or Convenience) Sampling

2. Quota Sampling
3. Judgment Sampling
4. Snowball Sampling

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 Convenient Sampling
Selecting easily accessible participants with no
randomization.

For example:
• One of the most common examples of convenience
sampling is using student volunteers as subjects for
the research.
• Subjects that are selected from a clinic, a class or an
institution that is easily accessible to the researcher.
• Five people from a class or choosing the first five
names from the list of patients.

Quota Sampling
Quota sampling refers to selection with controls, ensuring that specified numbers
(quotas) are obtained from each specified population subgroup.
• It may be households or persons classified by relevant characteristics, but with
essentially no randomization of unit selection within the subgroups.

For example,
• you include exactly 50 males and 50 females in a sample of 100.
Judgment/Purposive Sampling
A purposive sample refers to selection of units based on personal judgement
rather than randomization. Because, participants are selected based on certain
predetermined characteristics, no randomization.

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Snowball Sampling
Selecting participants by finding one or two participants and then asking them to
refer you to others.

For example, meeting a homeless person, interviewing that person, and then asking
him/her to introduce you to other homeless people you might interview.

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Types of Probability Sampling

▪ Simple random sampling

▪ Systematic sampling

▪ Stratified sampling

▪ Cluster sampling

▪ Multi-stage sampling

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 Simple Random Sampling

• Random Sampling
– Selected by using chance
or random numbers
– Each individual subject
(human or otherwise) has
an equal chance of being
selected
– Random samples are used
to avoid bias and other
unwanted effects.
– A sample that represents
the population.

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Systematic Sampling
• Systematic Sampling
– Select a random starting point and
then select every kth subject in the
population
– Simple to use so it is used often

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Stratified Sampling
Stratified Sampling
 Divide the population into at least two different groups with common
characteristic(s), then draw SOME subjects from each group (group
is called strata or stratum)
 Results in a more representative sample

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Cluster Sampling
 Cluster Sampling
 Divide the population into groups
(called clusters), randomly select
some of the groups, and then collect
data from ALL members of the
selected groups
 Used extensively by government
and private research organizations