Preclinical trials involve testing potential new drugs on animals before human testing to determine if they are safe and effective. This process involves several key steps: 1) Researchers identify a biological target related to a disease through basic research. 2) They develop a bioassay using cells or animals to test drug effects. 3) Potential drug compounds are screened in the bioassay to see if they act on the target. 4) Effective and toxic doses are established to find a safe range. If successful, 5) approval is sought from the FDA to begin clinical trials in humans.
In the slideshare i have discussed about principal of preclinical studies
various approaches towards preclinical studies
a route map of preclinical trials and its various methods
In the slideshare i have discussed about principal of preclinical studies
various approaches towards preclinical studies
a route map of preclinical trials and its various methods
An overview of ICH-GCP guidelines of clinical trials.
Good clinical practice (GCP): a standard for the design , conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.
ICH-GCP is an International Conference on Harmonization Good Clinical Practice.
The guideline was developed with consideration of the current good clinical practices of the European union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the world health organization
Toxicological Approach to Drug DiscoverySuhas Reddy C
For better understanding of students. This will give you a detailed explanation of Toxicological approach. Contact me through comment section if you need any assistance in understating
Pre-discovery
Understand the disease
Target Identification
Choose a molecule to target with a drug
Target Validation
Test the target and confirm its role in the disease
Drug Discovery
Find a promising molecule (a “lead compound”)
that could become a drug
FOMAT Medical Research is a site research network specializes in developing clinical. We offer a wide range of solutions for Sponsors, Clinical Contract Organizations (CROs), and Sites throughout the Americas. Visit here- https://www.fomatmedical.com
Roles and Responsibilities in Clinical Trials of Investigator, Study Coordinator, Sponsor, Monitor, a Contract research organization.
The clinical trial, definition, description, Different types of clinical trials, phases of clinical trial.
The clinical trial study team.
Requirements of the clinical trial study team.
Clinical research team role.
GCP- Good clinical practices.
Historically, drugs were discovered by identifying the active ingredient from traditional remedies or by serendipitous discovery, as with penicillin. More recently, chemical libraries of synthetic small molecules, natural products or extracts were screened in intact cells or whole organisms to identify substances that had a desirable therapeutic effect in a process known as classical pharmacology. After sequencing of the human genome allowed rapid cloning and synthesis of large quantities of purified proteins, it has become common practice to use high throughput screening of large compounds libraries against isolated biological targets which are hypothesized to be disease-modifying in a process known as reverse pharmacology. Hits from these screens are then tested in cells and then in animals for efficacy
This powerpoint presentation will help to know the introduction of Pre Clinical Trials.Hope you understand well.If you need more notes refer some pharma and Biotechnology books.
An overview of ICH-GCP guidelines of clinical trials.
Good clinical practice (GCP): a standard for the design , conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.
ICH-GCP is an International Conference on Harmonization Good Clinical Practice.
The guideline was developed with consideration of the current good clinical practices of the European union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the world health organization
Toxicological Approach to Drug DiscoverySuhas Reddy C
For better understanding of students. This will give you a detailed explanation of Toxicological approach. Contact me through comment section if you need any assistance in understating
Pre-discovery
Understand the disease
Target Identification
Choose a molecule to target with a drug
Target Validation
Test the target and confirm its role in the disease
Drug Discovery
Find a promising molecule (a “lead compound”)
that could become a drug
FOMAT Medical Research is a site research network specializes in developing clinical. We offer a wide range of solutions for Sponsors, Clinical Contract Organizations (CROs), and Sites throughout the Americas. Visit here- https://www.fomatmedical.com
Roles and Responsibilities in Clinical Trials of Investigator, Study Coordinator, Sponsor, Monitor, a Contract research organization.
The clinical trial, definition, description, Different types of clinical trials, phases of clinical trial.
The clinical trial study team.
Requirements of the clinical trial study team.
Clinical research team role.
GCP- Good clinical practices.
Historically, drugs were discovered by identifying the active ingredient from traditional remedies or by serendipitous discovery, as with penicillin. More recently, chemical libraries of synthetic small molecules, natural products or extracts were screened in intact cells or whole organisms to identify substances that had a desirable therapeutic effect in a process known as classical pharmacology. After sequencing of the human genome allowed rapid cloning and synthesis of large quantities of purified proteins, it has become common practice to use high throughput screening of large compounds libraries against isolated biological targets which are hypothesized to be disease-modifying in a process known as reverse pharmacology. Hits from these screens are then tested in cells and then in animals for efficacy
This powerpoint presentation will help to know the introduction of Pre Clinical Trials.Hope you understand well.If you need more notes refer some pharma and Biotechnology books.
Introduction
History
How are new drug discovered?
Bioinformatics in drug discovery
Tools for drug discovery
Successful drug
Software for drug discovery
Conclusion
References
Target identification, target validation, lead identification and lead
Optimization.
• Economics of drug discovery.
• Target Discovery and validation-Role of Genomics, Proteomics and
Bioinformatics.
• Role of Nucleic acid microarrays, Protein microarrays, Antisense
technologies, siRNAs, antisense oligonucleotides, Zinc finger proteins.
• Role of transgenic animals in target validation.
DRUG DISCOVERY & DEVELOPMENT PROCESS, it's a detail description about how drug is made available in market it's development and discovery of drug The Hole Study is given in This Topic.
Introduction to pre clinical screening of drugsKanthlal SK
Various Techniques and Methods for screening of new chemical entities in preclinical aspects (both invitro & invivo) for effective and safe clinical usage.
n drug development, preclinical development, also named preclinical studies and nonclinical studies, is a stage of research that begins before clinical trials can begin, and during which important feasibility, iterative testing and drug safety data are collected, typically in laboratory animals.
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Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
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Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
Francesca Gottschalk - How can education support child empowerment.pptxEduSkills OECD
Francesca Gottschalk from the OECD’s Centre for Educational Research and Innovation presents at the Ask an Expert Webinar: How can education support child empowerment?
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2. What do you think?
• Have you ever had to take a medicine to treat an illness?
• Have you ever wondered how researchers determine if the
medicines you take are safe or not?
3. • Pre-Clinical Trials and Clinical Trials are the processes by which
scientists test drugs and devices to see if they are SAFE and EFFECTIVE.
4. What is a Preclinical Trial?
• Preclinical trial - a laboratory test of a new drug or a new medical
device, usually done on animal subjects, to see if the hoped-for
treatment really works and if it is safe to test on humans.
5. There are two types of Research: Basic and
Applied
Basic Research: discovering new facts about how
things work, how they are made, or what causes a
biological event to occur. Basic research can
explore a topic, explain a topic or describe a topic.
For Example: A researcher discovered that genes
can be turned off or on by small RNA molecules in
the body. This study was conducted on worms. It
led to the Nobel Prize in 2006.
6. “Basic” vs. “Applied”
Research
Applied Research: Taking the
information discovered in basic
research and investigating how to
use it to treat and prevent
sicknesses.
Example: A researcher uses the
information about turning genes
off and on to find a drug that is
used to turn off genes that cause
diseases and disorders in humans.
Segment of DNA.
Many such
segments act as
genes.
7. Where Do We Get New Ideas For Research?
Ideas come from all kinds of scientists and medical professionals who do
research in universities, government labs, and in corporations.
8. Take a Minute to Discuss:
• What is a Pre-Clinical Trial?
• What is the difference between basic research and applied
research?
• What sickness or disease would you like to see an effective
treatment for?
9. There are several steps involved with
doing a Pre-Clinical Trial:
File for approval as an Investigational New Drug
(IND)5
4
3
2
1
Establish Effective and Toxic Doses
Screen the Drug in the Assay
Develop a Bioassay
Indentify a Drug Target
10. Steps in Doing a
Pre-Clinical Trial:
• Drugs usually act on either cellular or genetic chemicals
in the body, known as targets,
which are believed to be associated with disease.
• Scientists use a variety of techniques to identify and
isolate individual targets to learn more about their
functions and how they influence disease.
• Compounds are then identified that have various
interactions with the drug targets that might be helpful
in treatment of a specific disease.
Step One: Get an idea for a
drug target.
11. Finding the Right Target Is Not Easy
Parkinson’sDiseaseExample:
Parkinson's disease:
a disease which causes
deterioration of the
central nervous system
over a period of time.
This disease often
impairs the patient’s
movement, speech, and
other functions.
12. • Tremors or shaking occurs when cells in one part of brain die. These cells
communicate using a chemical called dopamine.
• Drugs that replace dopamine work only for a few years.
• Other Parkinson’s symptoms (depression, sleep disorder, digestive problems,
loss of brain function) have other causes.
• Another sign of Parkinson’s disease: many cells have deposits of a protein,
synuclein.
• Four drug companies are developing drugs to counter synuclein, even
though nobody knows if it is a cause or a consequence of Parkinson’s.
• Synuclein could be like a tombstone—a marker, not a cause of cell death.
How is Parkinson’s treated? Where should the
focus be?
13. • Drugs target specific points in biochemical pathways
• Biochemical pathways are series of chemical reactions
occurring within a cell. In each pathway, a principal
chemical is modified by chemical reactions.
• Examples of different types of biochemical pathways:
A
E B
D C
A B C D E
Any step in the pathway, for
example from A to B, or B to C,
might be a target for the right
drug.
* See slide
note
14. Step Two: Developa Bioassay
A Bioassayis a “live”systemthat can be usedto
measuredrug effect.
• It may be a culture of cells or
organs or a whole animal.
For example:
• Zebra-fish embryos - you can
see effects of drugs on bone
density, blood vessel growth
and many other systems of the
zebra-fish.
Steps in Doing a
Pre-Clinical Trial:
15. • This is the actual test of the drug
on the chosen bioassay.
• This will determine if the drug is
SAFE and if it is EFFECTIVE in the
bioassay (BEFORE it is ever tested
on humans!)
Steps in Doing a
Pre-Clinical Trial:
Step Three: Screen the
drug in the Bioassay.
16. • Most drugs have a toxic level or an amount at which the
drug will become
harmful instead of helpful.
Steps in Doing a
Pre-Clinical Trial:
Step Four: Establish what dosage
amount of the drug is safe and what
dosage amount of the drug is toxic.
17. Toxicity study
• Acute toxicity- Acute toxicity studies are required
for all drugs these studies involve single
administration of the agent up to the lethal level
in at least two species. E.g. one rodent and one
nonrodent.
• Subacute & chronic toxicity- subacute and
chronic testing are required for most agents,
especially those intended for chronic use. Test s
are usually carried out for at least the amount of
time proposed for human application, i.e. 2-4
week (subacute) or 6-24 months (chronic),in at
least two species.
18. IND must show how the drug:
• Is manufactured.
• Appears (color, solubility, melting point,
particle size, moisture content).
• Formulated (pills, liquid, etc. + inactive ingredients).
• Will be analyzed for purity, concentration, stability.
• Will be tested for safety (this will be the basis for allowing
first use in humans).
Steps in Doing a
Pre-Clinical Trial:
Step Five: Application is made to the
Food and Drug Administration (FDA)
as an Investigational New Drug (IND).
19. Think Break:
• How are these steps like the steps of the Scientific Method?
• Why would research scientists use a Bioassay instead of a human
subject to test a new drug?
• What percentage of drugs do you think get this far in the process?
20. Review:StepstoNewDrug Discovery
Pre-ClinicalTrials
Get idea for drug target
Develop a bioassay
Screen chemical compounds in assay
Establish effective and toxic amounts
File for approval as an Investigational
New Drug (IND) (leads to clinical trials)
21. Can you summarize the process?
With a partner or your group, write a summary of
the Pre-Clinical Trial Process. Use the following
words to help you:
Drug
Safe
Effective
Basic Research
Applied Research
Target
Biochemical Pathway
Bioassay
Toxic
Investigational New Drug (IND)
