BIOSTATISTICS-DRUG
DEVELOPMENT
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2 STATISTICS
Statistics is a scientific study of numerical
data based on natural phenomena.
It is also the science of collecting,
organizing, interpreting and reporting data.
Pharmaceutical statistics is the application
of statistics to matters concerning the
pharmaceutical industry. This can be from
issues of design of experiments, to analysis
of drug trials, to issues of commercialization
www.DuloMix.com of a medicine. Statistics and its application
3 APPLICATIONS
Evaluate the activity of a drug; e.g.; effect of caffeine on
attention; compare the analgesic effect of a plant extract
and NSAID
To explore whether the changes produced by the drug are
due to the action of drug or by chance
To compare the action of two or more different drugs or
different dosages of the same drug are studied using statistical
methods.
To find an association between disease and risk factors such as
Coronary artery disease and smoking
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4
Public health, including epidemiology, health services research, nutrition,
environmental health and healthcare policy & management.
Design and analysis of clinical trials in medicine
Population genetics, and statistical genetics in order to link variation in
genotype with a variation in phenotype.
In biomedical research, this work can assist in finding candidates for gene
alleles that can cause or influence predisposition to disease in human
genetics
Analysis of genomics data. Example: from microarray or proteomics
experiments. Often concerning diseases or disease stages.
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5
Systems biology for gene network
inference or pathways analysis
Demographic studies: Age, gender,
height, weight, BMI
Epidemiology: deficiency of iron in
anemia, iodized salt and goiter, hygiene
and microbial disease
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6 EARLY CLINICAL STAGE
Pharmacokinetics
Dose finding
Metabolism and elimination
Drug interaction studies
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7 DEVELOPMENT OF MARKET LAUNCH
◼ Clinical Development Plan
◼ What needs to be done to support desired claims in
world markets (Regulatory requirements)
◼ What trials, which drug interaction studies
◼ What are the competitors and their profiles
◼ Is there something we can demonstrate value for the patient
(efficacy or safety)
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8 REGULATORY SUBMISSIONS
Synthesize the data
Provide thorough structure description
Provide standardized information in agreed format
Support the package
Agree the label
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9 LIFE CYCLE MANAGEMENT
Product is on the market
How to we maximize it’s value
Broaden the indications for use
Identify patients currently not treated
Look for ways to demonstrate the strength of the product compared to others
Look for economic or quality of life benefits