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Prepared by:
Gpoup:
Accepted:Presentation
Drug discovery and drug development
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Introduction :
Drug discovery and development is a complex and
multifaceted process that involves identifying
promising drug candidates, testing them
thoroughly, and ultimately bringing them to market
as safe and effective treatments. This process is
critical for advancing medical science and
improving patient outcomes.
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Identifying Drug Targets
1 Target Identification
Researchers use
various techniques to
identify potential
drug targets, such as
analyzing disease
pathways, genetic
data, and protein
interactions. 2 Target Validation
The identified targets
must be thoroughly
validated to ensure
they are suitable for
drug development
and have the
potential to treat the
disease effectively. 3 Assay Development
Sensitive and specific
assays are developed
to measure the
activity of drug
candidates against
the target and guide
the lead optimization
process.
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Screening and Lead Optimization
Screening
Researchers use high-
throughput screening to
test thousands of
potential drug candidates
against the identified
target, searching for
promising lead
compounds. Lead Optimization
The most promising lead
compounds are then
further optimized through
iterative cycles of
chemical modification and
testing to improve their
potency, selectivity, and
druglike properties. In Silico Approaches
Computational methods,
such as molecular docking
and structure-based drug
design, can accelerate the
lead optimization process
by predicting the
interactions between drug
candidates and their
targets.
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Preclinical Testing and Animal Studies
1 Safety Evaluation
Potential drug candidates undergo extensive in vitro and in vivo
testing to assess their safety, including toxicology studies and
pharmacokinetic/pharmacodynamic analysis.
2 Efficacy Evaluation
Researchers use animal models to evaluate the efficacy of drug
candidates in treating the target disease, providing crucial data to
support clinical trials.
3 Formulation Development
The drug formulation, including the delivery route and dosage form,
is optimized to ensure optimal therapeutic effects and patient
adherence.
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Clinical Trials: Phases I, II, and III
Phase I
Small-scale studies to assess the safety,
tolerability, and pharmacokinetics of the
drug candidate in healthy volunteers. Phase II
Larger studies to evaluate the efficacy
and further refine the dosing regimen in
patients with the target disease.
Phase III
Large-scale, pivotal trials to
conclusively demonstrate the safety
and efficacy of the drug candidate in a
diverse patient population. Regulatory Approval
Upon successful completion of clinical
trials, the drug candidate is submitted
for regulatory review and approval to
ensure its safety and efficacy.
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Regulatory Approval and Post-
Marketing Surveillance
Regulatory Review
Drug regulatory agencies, such as the FDA or EMA, thoroughly review the
clinical trial data and other information to determine if the drug can be
approved for marketing.
Approval and Launch
If approved, the drug is then manufactured and distributed for use by
healthcare providers and patients.
Post-Marketing Surveillance
Ongoing monitoring of the drug's safety and efficacy in the real-world
patient population is critical to identify any unexpected adverse effects or
issues.
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Challenges in Drug Discovery and
Development
High Costs
The drug discovery
and development
process is
incredibly
expensive, with
estimates ranging
from $1-2 billion
per successful
drug. Long Timelines
It can take 10-15
years or more to
bring a new drug
from initial
discovery to
market approval. High Failure Rates
The majority of
drug candidates
fail during the
development
process due to
issues with safety,
efficacy, or
commercial
viability. Regulatory Hurdles
Navigating the
complex regulatory
environment and
meeting stringent
approval
requirements can
be a significant
challenge.
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The Future of Drug Discovery and
Development
Innovative Technologies
Emerging technologies,
such as artificial
intelligence, machine
learning, and high-
throughput screening, are
poised to transform and
accelerate the drug
discovery and
development process. Personalized Medicine
Advances in genomics
and biomarkers are
enabling the development
of targeted therapies
tailored to an individual's
genetic profile and
disease characteristics. Global Collaboration
Increased international
cooperation and data
sharing among
researchers,
pharmaceutical
companies, and
regulatory bodies can
help address the
challenges in drug
development and improve
patient outcomes
worldwide.
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Literature:
1. English for the pharmaceutical industry : textbook / M. Bucheler [and etc.]. - New
York : Oxford University Press, 2014. - 96 p. + эл. опт. диск ( CD-ROM). –
2)Murphy, R Essential Grammar in Use: A self-study reference and practice book for
elementary students of English [ Текст] : учебник R Murphy. - 3th ed. - [S. l.] :
Cambridge university press, 2013. – 319
3)Jakeman, V. New Insight into IELTS [ Текст] : workbook / V. Jakeman, C. McDowell.
- Cambridge : Cambridge university press, 2013. - 144 p
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