The document provides an overview of the drug discovery process, including the need for new drugs, approaches to discovery, and changes over time. It discusses target identification, validation, lead identification, optimization, and preclinical pharmacology/toxicology. The phases of clinical trials are also summarized, including Phase I safety trials in healthy volunteers, Phase II therapeutic exploration trials, and large Phase III randomized controlled trials. The roles of various parties in clinical trials are also outlined.
Concept of Pharmacovigilance, history and development of pharmacovigilance, WHO International drug monitoring programme, Pharmacovigilance programme of India
Concept of Pharmacovigilance, history and development of pharmacovigilance, WHO International drug monitoring programme, Pharmacovigilance programme of India
Drug discovery is a time-consuming, high-investment, and high-risk process in traditional drug development. Drug repositioning has become a popular strategy in recent years.
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.
Pharmacovigilance is a scientific discipline concerned with the collection, detection, assessment, monitoring, and prevention of adverse effects of pharmaceutical products.
Pharmacovigilance is a branch of Pharmacoepidemiology and is restricted to the study of adverse effects of drugs.
IND (Investigational New Drug) industrial perspectiveAYESHA NAZEER
Describing the Industry's/sponsor's/drug manufacturers' perspective of the Investigational New Drug Application (IND) program based on the survey conducted by the Office Of Inspector General (OIG).
A presentation outlining the various processes a chemical compound undergoes (thorough & rigorous screening procedures) before it is finally introduced into the drug market
Drug discovery is an inventive process of identifying a compound or new medication based on knowledge of biological target, therapeutically useful in treating and curing a disease.
The process of drug discovery involves the identification of candidates,synthesis, characterization,screening,assays for therapeutic efficacy.
Once a compound has shown its value in these tests, it will begin the process of drug development prior to clinical trials.
Drug discovery is a time-consuming, high-investment, and high-risk process in traditional drug development. Drug repositioning has become a popular strategy in recent years.
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.
Pharmacovigilance is a scientific discipline concerned with the collection, detection, assessment, monitoring, and prevention of adverse effects of pharmaceutical products.
Pharmacovigilance is a branch of Pharmacoepidemiology and is restricted to the study of adverse effects of drugs.
IND (Investigational New Drug) industrial perspectiveAYESHA NAZEER
Describing the Industry's/sponsor's/drug manufacturers' perspective of the Investigational New Drug Application (IND) program based on the survey conducted by the Office Of Inspector General (OIG).
A presentation outlining the various processes a chemical compound undergoes (thorough & rigorous screening procedures) before it is finally introduced into the drug market
Drug discovery is an inventive process of identifying a compound or new medication based on knowledge of biological target, therapeutically useful in treating and curing a disease.
The process of drug discovery involves the identification of candidates,synthesis, characterization,screening,assays for therapeutic efficacy.
Once a compound has shown its value in these tests, it will begin the process of drug development prior to clinical trials.
Part of the MaRS Best Practices Series - Pre-Clinical development workshop
http://www.marsdd.com/bestpractices
Speaker: Jack Jiang, VP Medicinal and Analytical Chemistry, Ricerca BioSciences
Back Rapid lead compounds discovery through high-throughput screeningrita martin
High-throughput screening process are used by today most of the drug discovery industries, this process helps pharmaceutical researches to make drug discovery process faster and also increase the quality and quantity of drugs production. This process in combination with robotics, data processing and control software, liquid handling devices and sensitive detectors allows a researcher to quickly conduct millions of chemical, genetic or pharmacological tests
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iNovacia offers high quality high-throughput screening services supported by a compound collection and screening libraries of highest international standards. iNovacia has a broad experience with all major target families and assay types.
The slide provides a basic understanding about Clinical Research process and the various Phases of Drug Discovery and Development. It also explains about the various trial designs and techniques in research such as blinding and randomization. It may be useful for giving a basic class for Fourth Year B.Pharm Students.
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
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How the drugs has been brought into the market, what are the several steps involved in the discovery of drugs.
clinical trials are also involved.
COVID-19 new clinical trials have been incarporated
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.
For more information, visit-www.vavaclasses.com
Ethnobotany and Ethnopharmacology:
Ethnobotany in herbal drug evaluation,
Impact of Ethnobotany in traditional medicine,
New development in herbals,
Bio-prospecting tools for drug discovery,
Role of Ethnopharmacology in drug evaluation,
Reverse Pharmacology.
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Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
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The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
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Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
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2. DRUG DISCOVERY
• The processes of new drug discovery and
development are long, complicated and
dependent upon the expertise of a wide
variety of scientific, technical and
managerial groups.
3. Why are new drugs needed?
• unmet medical need; new diseases (AIDS, Alzheimer’s;
obesity); low efficacy (dementia, cancer); side effects
(antidepressants, antipsychotics)
• downstream health costs; (Alzheimer’s; spinal injury)
• cost of therapy; (Viagra, Interleukins)
• costs to individual/country; (depression)
• sustain industrial activity; pharmaceutical industry
employs thousands and makes a massive contribution to
overseas earnings); patent expiry
4. Approaches to drug discovery
• Historical; cinchona (quinine) & willow barks (aspirin);
chinese medicine currently.
• Study disease process; breast cancer (tamoxifen);
Parkinson’s disease (L-dopa)
• Study biochem/physiological pathway; renin/angiotensin
• Develop SAR to natural compound; beta-adrenoceptors
(propranolol), H2-receptors (cimetidine)
• Design to fit known structurally identified biological site;
angiotensin-converting enzyme inhibitors
• By chance (serendipity); random screening (HTS);
penicillin; dimenhydramate; pethidine
• Genomics; identification of receptors; gene therapy;
recombinant materials
5. The changed context of drug discovery
and development
The 1800s: natural sources; limited possibilities; prepared
by individuals; small scale; not purified, standardised or
tested; limited administration; no controls; no idea of
mechanisms.
The 1990s and 2000: synthetic source; unlimited
possibilities; prepared by companies; massive scale;
highly purified, standardised and tested; world-wide
administration; tight legislative control; mechanisms
partly understood, still understanding.
9. • About 2.6m animals/y used in procedures in UK (11.6m
in Europe)
• Likely to increase; more research, more targets, genetic
capability
• 3Rs -- 3Rs -- 3Rs
• REPLACEMENT: use non-animal tests if possible
(cheaper, less trouble, less variable but not possible for
everything at this time)
• REDUCTION: get the statistics right, don’t replicate work
unnecessarily, don’t overbreed
• REFINEMENT: reduce suffering and severity of
procedure, pay attention to housing, stress, husbandry
and rich environments, proper analgesia and pre- and
post- operative care
10. 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.
11. “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 Segment of DNA.
Many such
genes that cause diseases and disorders
segments act as
in humans genes
12. Process of Drug Discovery
• Target Identification
• Target Validation
• Lead Identification
• Lead Optimization
• Preclinical Pharmacology and Toxicology
13. Target Identification
• Identifying targets include
protein expression, protein
biochemistry.
• Sequence analysis,
positional cloning, functional
cloning.
• Important to determine
whether the novel targets are
actually relevant to the
physiology of the disease.
14. Target Validation
• Target identified will affect an appropriate biological
response
• CHEMOGENOMICS;defined as the discovery and
description of all possible drugs to all possible targets.
• Chemical Genetics; involves the use of chemical probes
to understand some specific features of biology and can
be viewed as subset of chemogenomics.
• LIMITATIONS;Compensatory mechanism of the
organism.
15. Lead Identification
• “lead compound”: structure that has some activity
against the chosen target, but not yet good enough to be
the drug itself.
Virtual Pharmacaphore
Screening Mapping Docking
Chemoinformatics QSAR Chemical Genetics
16. • The pharmacophore is the precise section of the
molecule that is responsible for biological activity.
• This may enable one to prepare a more active molecule
• This may allow the elimination of “excessive”
functionality, thus reducing the toxicity and cost of
production of the active material
• This can be done through synthetic modifications
17. Lead Optimization
• Once a lead has been discovered, it is
important to understand precisely which
structural features are responsible for its
biological activity.
18. Pre-Clinical Pharmacology and
Toxicology
• TOXICOLOGY
• Thalidomide was developed by German pharmaceutical company
Grünenthal. It was sold from 1957 to 1961 in almost 50 countries under at
least 40 names. Thalidomide was chiefly sold and prescribed during the
late 1950s and early 1960s to pregnant women, as an antiemetic to combat
morning sickness and as an aid to help them sleep. Before its release,
inadequate tests were performed to assess the drug's safety, with
catastrophic results for the children of women who had taken thalidomide
during their pregnancies
• Antiemetic = a medication that helps prevent and control nausea and
vomiting
20. • 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.
21. There are several steps involved with doing a Pre-
Clinical Trial
• File for approval as an Investigational New Drug (IND)
5
•
Establish Effective and Toxic Doses
4
3 Screen the Drug in the Assay
2 Develop a Bioassay
1
Indentify a Drug Target
22. Scientific Aspects of Clinical Trial
Phases of Clinical Trial
• Phase I (Human pharmacology and safety): First in
man safety
• Phase II (Therapeutic exploration and dose ranging):
First in patient dose, dosage form
• Phase III (Therapeutic confirmation/comparison) :
Efficacy, ADRs
• Phase IV (Post marketing surveillance) : Evaluation in
the real clinical setting
23. Phase I
• Objectives
1. To assess a safe & tolerated dose
2. To see if pharmacokinetics differ much from animal to man
3. To see if kinetics show proper absorption, bioavailability
4. To detect effects unrelated to the expected action
5. To detect any predictable toxicity
– Inclusion criteria
– Healthy volunteers : Uniformity of subjects: age, sex,
nutritional status [Informed consent a must]
– Exception: Patients only for toxic drugs Eg AntiHIV, Anticancer
– Exclusion criteria
– Women of child bearing age, children,
24. Phase II
• First in patient [ different from healthy volunteer]
• Early phase [20 – 200 patients with relevant disease]
– Therapeutic benefits & ADRs evaluated
– Establish a dose range to be used in late phase
– Single blind [Only patient knows] comparison with standard drug
• Late phase [ 50 – 500]
– Double blind
– Compared with a placebo or standard drug
• Outcomes
– Assesses efficacy against a defined therapeutic endpoint
– Detailed P.kinetic & P.dynamic data
– Establishes a dose & a dosage form for future trials
• Takes 6 months to 2 years [ 35% success rate
25. Phase III
• Large scale, Randomised, Controlled trials
• Target population: 250 – 1000 patients
• Performed by Clinicians in the hospital
• Minimises errors of phases I and II
• Methods
– Multicentric Ensures geographic & ethnic variations
– Diff patient subgroups Eg pediatric, geriatric, renal impaired
– Randomised allocation of test drug /placebo / standard drug
– Double blinded:
– Cross over design
– Vigilant recording of all adverse drug reactions
– Rigorous statistical evaluation of all clinical data
• Takes a long time: up to 5 years [25% success
26. Phase IV or Post marketing
Surveillance
• No fixed duration / patient population
• Starts immediately after marketing
• Report all ADRs
• Helps to detect
– rare ADRs
– Drug interactions
– Also new uses for drugs [Sometimes called Phase V]
27. Clinical Trial: Legal & Procedural
aspects
Elements of a Clinical Trial
• Aim or objective
• Protocol : study design
• Ethics committee clearance
• Regulatory approval whenever required
• Informed consent
• Implementation of protocol
• Collection of data
• Compilation of data, analysis and interpretation
• Report writing
28. Participating Parties in Clinical Trial
1. Patient / Healthy volunteer: Subject of the trial
2. Clinical Pharmacologist, Clinical Investigator & team: [Qualified and
competent] Conducts the clinical trial; reports all adverse events
3. Institution where trials are held : [Approval required] Provides all
facilities
4. Ethical Review Board or Institutional Ethical Committee:
-Supervises and monitors every step;
– Safeguard the welfare and the rights of the participants
– 5. Sponsor
– Pays for all expenses;
– Appoints competent investigators,
– Ships all drugs for the trial,
– Files all papers to legal / regulatory authorities,
6. Regulatory Authorities:
Legal authority on the outcomes of the trial