pharmaceutical

P
Biostatistics
 Contents
1. Statistics and Biostatistics:.......................................................................................................2
2. Applications of biostatistics:....................................................................................................3
2.1 In Anatomy and Physiology..............................................................................................3
2.2 In Pharmacology...............................................................................................................3
2.3 In Medicine.......................................................................................................................3
2.4 Clinical medicine..............................................................................................................3
2.5 In Health Planning and Evaluation...................................................................................3
2.6 In Biotechnology...............................................................................................................3
2.7 Statistical Expertise in Drug Discovery............................................................................4
2.8 Assay Data in Drug Discovery..........................................................................................4
2.9 Computers in Medicine.....................................................................................................4
2.10 Data analysis software......................................................................................................4
5. Sample and population:............................................................................................................4

2
 Introduction to Pharmaceutical Bio-statistics

1. Statistics and Biostatistics:

The word “statistics” has originated from Latin words status (meaning ‘state').

Statistics is a science which deals with the collection, presentation, analysis and interpretation of
numerical data.

Statistics applied in biological sciences is simply called Biostatistics or Biometry meaning

biological measurement.

Difference between Statistics and Bio-statistics

Statistics Bio-statistics
Application It encompasses methods of It is a specialized part of statistics
collecting, organizing, analyzing, that focuses on the collection,
presenting, and interpreting data to analysis, interpretation, and
help draw conclusions or make presentation of data specifically for
more informed decisions. biology, medicine, and health related
fields.

Expertise Statisticians may have focus on a Biostatisticians possess specialized

different field of expertise or are knowledge and expertise in handling
generalists with a broad biological and health-related data,
understanding of statistical considering factors specific to these
principles and methodologies that fields.
can be applied to various types of
data.

Data Characteristics Statistical analysis encompasses a Biostatistical methods are tailored to

wider range of statistical address these complexities within
techniques. medical research

Research Questions Statistics caters to a broader Biostatistics primarily supports

spectrum of research questions research questions related to
depending on the specific domain. healthcare outcomes, treatment
comparisons, disease prevalence and
genetic studies.
.

3
 2. Applications of biostatistics:
The followings are some important applications and uses of Biostatistics as veritable tool in
health and health-related areas. It has huge application in pharmaceutical science and in medical
technology.

Biological Applications

2.1In Anatomy and Physiology

 To define what is normal or healthy in a population.

 To find the limits of normality in variables such as weight and pulse rate etc. in a population.

 To find the correlation between two variables such as height and weight, whether weight
increases or decreases proportionately with height.

2.2In Pharmacology
 To find the action of drug – A drug is given to humans to see whether the changes produced
are due to the drug or by chance.

 To compare the action of two different drugs or two successive dosages of the same drug.

 To find the relative potency of a new drug with respect to a standard drug.

2.3In Medicine
 To compare the efficacy of a particular drug, operation or line of treatment

 To find an association between two attributes such as cancer and smoking or filariasis and
social class.

 To identify signs and symptoms of a disease or syndrome.

2.4Clinical medicine
 Documentation of medical history of diseases.

 Planning and conduct of clinical studies.

 Evaluating the merits of different procedures.

2.5In Health Planning and Evaluation

 The methods used in dealing with statistics in the fields of medicine, biology and public
health for planning, conducting and analyzing data.

4
 2.6In Biotechnology
 Study of genetic modification of plants and animals to gene therapy, medicine and drug
manufacturing, reproductive therapy, and even energy production.

Pharmaceutical Applications

2.7Statistical Expertise in Drug Discovery

 One class of proteins, antibodies, is of particular interest. Antibodies are an essential part of the
immune system, since they bind to antigens (proteins or sugars) on the surface of a bacteria
or virus and so mark it out as an invader. They are now being investigated for a range of uses
including cancer treatment.

2.8Assay Data in Drug Discovery

 As one might expect, there are usually a large number of assays used to optimize molecules
and these vary in complexity and type. The assay value is determined over a range of
concentrations and a statistical dose- response model is fit to the data.

2.9 Computers in Medicine

The computers can be used and are used now in solving various problems in biostatistics for;

3. Collection, compilation, tabulation and diagrammatic presentation in the manner required

for any size of data for completeness and accuracy.

4. Finding averages; coefficient of variation, standard deviation and standard error and
percentiles, etc. of any size of data simultaneously.

2.10 Data analysis software

 The MINITAB, SPSS, SAS and STATA are some of the well-known statistical software
packages for the personal computer, which are used for the tabulation and statistical
analysis of data.
 There are many software used in pharmaceutical industry and in medical technology.
 These software are further categorized on the basis of task performing by the software and
their working principle like software assessing pharmacokinetic parameters, ligand
interactions and molecular dynamic, molecular modeling and structural activity relationship,
image analysis and visualizes, data analyzer and behavior analysis software. Simply they
analyses data and further proceed.

5. Sample and population:

Two important terms that the reader should be fully acquainted with are samples and
populations.

5
Population: It is an entire group of people or study elements, persons, things or measurements
for which we have an interest at a particular time

Sample: is the process of selection of a subset of individuals from the population to estimate the
characteristics of the whole population. The number of entities in a subset of a population is
selected for analysis.

In statistics, the sample size is the measure of the number of observations used for determining
the estimations of a given population. The size of the sample has been drawn from the
population.

Pharmaceutical examples of populations and samples are given in Table.

As may be imagined, characterizing the properties of a particular population requires measuring

all the constituents of that population .Thus to fully characterize the weights of tablets in a
particular batch, every tablet in that batch should be weighed. For some products, this could
involve the weighing of a million tablets! It is impractical to do this routinely, so small samples
are randomly removed from the population and characterized in terms of a particular property.
Thus, to use an example from Table, by measuring the weights of a sample of tablets removed
from a batch, we can make assumptions about the weights of all tablets in the batch.

Example (task) Population parameter Sample

Characterization of the weights All tablets that 100 tablets removed for
of tablets in a particular batch. constitute the batch. weighing

Evaluation of the incidence of All employees of the 50 named workers at the

asthma in a certain chemical company. company.
company employing 500
workers.

Refrences :
 NILTON JS Statistical methods in Biological and health Sciences.

 Hoel PG ,Port SC, Stone CJ Introduction to Statistical Theory