Biostatistics in Pharmaceutical Product Development | Industrial Pharmacy

Biostatistics in Pharmaceutical Product Development | Industrial Pharmacy

What is Biostatistics?

Statistics is the discipline that concerns the collection, organization, analysis, interpretation and presentation of data. In applying statistics to a scientific, industrial, or social problem.

Biostatistics

Biostatistics is the application of statistics in the development and use of therapeutic drugs and devices in humans and animals.

Biostatistics involve the use of scientific and quantitative procedures in descriptive and inferential statistics to evaluate the quality of evidence in biological sciences. It also involves the statistical processes and methods used for analysing the biological phenomena. Biostatistics is a science that includes designing of biological and experimental study designs as well as synthesis, analysis, and interpretation of data obtained from such studies.

Biostatistics is a wide branch of biological sciences in which the theories in statistics are applied to the living-world problems in health and diseases. It involves various statistical operations, such as designing and conducting biomedical experiments, clinical trials, and development of related computational algorithms. Biostatistics  forms an important part in epidemiological research, development of health policies, health economics, public health administration, evidence-based practice in clinical medicine, genomics, proteomics, and development of various pharmaceutical products.

Statisticians often use the method of comparison.

We want to know the effect of a treatment (like the Salk vaccine) on a response (like getting polio).

Compare the responses of a treatment group with a control group.

Biostatistics covers applications and contributions not only from health, medicines and, nutrition but also from fields such as genetics, biology, epidemiology, and many others.

It is mainly consists of various steps like generation of hypothesis, collection of data, and application of statistical analysis.

Any science needs precision for its development. O Precision is all the more important when it comes to health sciences. For precision; facts, observations or measurements have to be expressed in figures.

Pharmaceutical Industry

Standard pharmaceutical development practices in experimental design, trial conduct, and statistical analysis are in need of review and revision if the goals of assuring the development and approval of safe, effective pharmaceuticals are to be maintained.

The last four decades have confirmed the value of prospective, controlled, blinded, randomized clinical trials in pharmaceutical development.

Refinements statistical of experimental designs analyses, along with and global harmonization of regulatory dossiers, have led to our present status where the basic tenets of phase I to III clinical trials are ubiquitous.

Applications

• Medicine is essentially an empirical science. It depends on observations and not on theories or theorems.
• As a part of clinical practice or research we deal with many observations, which when systematically arranged, are called Data.
• The process of converting data into information requires a special approach called statistics.
• 'Statistic' means a measured or counted fact or piece of the information, stated as a figure such as height of one person, birth weight of a baby etc.

History

Sir Francis Galton is considered as the Father of Biostatistics.

He was the first to apply statistical methods to the study of human differences and inheritance of intelligence, and introduced the use of Questionnaires and Surveys for collecting data on human communities, which he needed for genealogical and biographical works and for his anthropometric studies.

Statistics will assume a more inter disciplinary form. Use of software other than SAS likely to grow further. In India, innovative statistical methods will help propel the development of biosimilars.

The future is exciting with statistics being used for real world evidence, development of biosimilars, mining of adverse event data and becoming a core function in medicinal product development and lifecycle maintenance.

ROLE OF BIOSTATISTICIANS

• Identify and develop treatments for disease and estimate their effects.
• Identify risk factors for diseases.
• Design, monitor, analyze, interpret, and report results of clinical studies.
• Develop statistical methodologies to address questions arising from medical/public health data.
• Locate, define & measure extent of disease
• Ultimate objective
• Improve the health of individual & community

Application and uses of Biostatistics as a science in Physiology

Application and uses of Biostatistics as a science.. in Physiology, 

a. to define what is normal/healthy in a population

b. to find limits of normality c. to find difference between means and proportions of normal at two places or in different periods.

d. to find the correlation between two variables X and Y such as in height or weight. For eg. Weight increases or decreases proportionately with height and if so by how much has to be found.

Pharmacology

To find the action of drug - a drug is given to animals or 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

To find action of drug.

To compare action of two different drugs.

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

In Medicine, a. To compare efficacy of particular drug, operation or line of treatment. b. To find association between two attributes eg. Oral cancer and smoking c. To identify signs and symptoms of disease/ syndrome.

Biostatistics in clinical trials

• Clinical Trials
• Visit Clinical Trials.gov.
• Statistics in Drug Development
• Study design
• Clinical data
• Statistical modeling
• Other topics
• Statistics in Drug Development

Biostatistics: Responsibilities

• Design the study and develop the protocol.
• Design the randomization algorithm if needed.
• Draft the statistical analysis plan (SAP) Programming the study data based on the SAP: tables/ figures/ listings (TFLs). 
• Present the results and write the interpretation of study results in clinical study report (CSR). Statistics in Drug Development

According to Lord Kelvin,

when you can measure what you are speaking about and express it in numbers, you know something about it but when you can not measure, when you can not express it in numbers, your knowledge is of meagre and unsatisfactory kind.