3. Points of Presentation Topic
Introduction of Bio-pharmaceutics
Application of bio-pharmaceutics
Conclusion
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4. What is Biopharmaceutics?
The word ‘Bio’ means life and
‘Pharmaceutics’
– general area of study concerned with the
formulation, manufacture, stability and
effectiveness of pharmaceutical dose and
dosage form of a drug.
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5. Definition
Study of the factors influencing the
bioavailability of a drug in man and animals
and the use of this information to optimize
pharmacological or therapeutic activity of drug
products in clinical application.
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6. Pharmacokinetics & Pharmacodynamics
Pharmacokinetics
The effects of body upon drug ie the change in drug
molecule by the body. It includes absorption,
distribution, metabolism and excretion (ADME) of drug
after administration.
Pharmacodynamics
The effects of drug upon body. ie the change in
biochemical system by the drug molecule .It include the
mechanism of drug action and the response of drugs.
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7. Scope of Biopharmaceutics
1. Encompasses all possible effects observed
following the administration of the drug in the
various dosage forms.
2. Encompasses all possible effects of various
dosage forms on biological response
3. Encompasses all possible physiological factors
which may affect the drug in various dosage forms.
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8. Some Pharmaceutic Properties
Some drugs are intended for topical or local
therapeutic action at the site of administration. For
these drugs, systemic absorption is undesirable.
Drugs intended for local activity generally have a
direct pharmacodynamic action without affecting
other body organs. These drugs may be applied
topically to the skin, nose, eyes, mucous
membranes, buccal cavity, throat and rectum.
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9. Application of biopharmaceutics in new drug
development
Modern discovery is the product of cooperation.
Both public & private organization play an unique roles in
translating basic research into medicine.
Major biopharmaceutical companies are the primary source
of R & D funding of new medicines.
Smaller companies conduct basic research , drug discovery
, preclinical experiments & in some cases clinical trials.
The national institute of health(INH) provides leadership &
funding stimulate basic research & early stage
development of technologies.
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10. Application of biopharmaceutics in designing of drug
delivery system
The term drug delivery covers a broad range of
techniques used to get therapeutic agents into the human
body.
The frequency of administration or the dosing interval of
any drug depends upon its half life or mean residence
time (MRT) & its therapeutic index .
When drug is delivered as a conventional dosage form
such as a tablets , the dosing interval is much shorter than
the half life of the drug resulting in a no. of limitations
associated with such a conventional dosage forms.
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11. Importance of Biopharmaceutics in the Overall
Development Process
Biopharmaceutics is an integral component of the overall
development cycle of a drug
Evaluation begins during the drug discovery process,
proceeds through compound selection, preclinical efficacy
and safety testing, formulation development, clinical efficacy
studies, and post approval stages.
At each stage, biopharmaceutical scientists interface with in
multiple disciplines including discovery chemistry and
biology, drug safety assessment, clinical development,
pharmaceutical development, regulatory affairs, marketing,
and manufacturing
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12. Conclusions
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The discovery & development of new medicines is
a long completed process.
Research based pharmaceutical companies are
committed to advancing science & bringing new
medicines to patients.
Increased support from govt. & organization may
helps in development safer & cost effective
medicines.