The document discusses various approaches to drug discovery, including pharmacological, toxicological, and preclinical trials. It describes the components of pharmacological evaluation including selectivity testing, pharmacological profiling in vitro and in vivo, and safety pharmacology testing of major organ systems like central nervous system, cardiovascular, and respiratory systems. The goal of preclinical trials is to determine if a new drug works and is safe to test in humans using animal models and evaluating its pharmacological effects, toxicity, and safety pharmacologically.
clinical and preclinical approaches to drug discovery.Here we mainly deals with preclinical approaches, ie. Pharmacological approach and toxicological approach
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
Pharmacovigilance AND ADVERSE DRUG REACTIONS.
MONITORING REPORTING ROLE OF PHARMACIST.
CLASSIFICATION OF ADR. MECHANISM OF ADR
ROLE OF PHARMACIST IN MANAGING ADR. AUGMENTED, BIZZARE, CONTINOUS, DELAYED, END OF TREATMENT, ABCD, ABCDE.
clinical and preclinical approaches to drug discovery.Here we mainly deals with preclinical approaches, ie. Pharmacological approach and toxicological approach
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
Pharmacovigilance AND ADVERSE DRUG REACTIONS.
MONITORING REPORTING ROLE OF PHARMACIST.
CLASSIFICATION OF ADR. MECHANISM OF ADR
ROLE OF PHARMACIST IN MANAGING ADR. AUGMENTED, BIZZARE, CONTINOUS, DELAYED, END OF TREATMENT, ABCD, ABCDE.
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
Spontenous adr reporting in india
PASSIVE survillence system, data assement
data aciqsition, data interpretation, what all information required in ADR form, WHEN TO REPORT
BLUE CARD,YELLOW CARD, WHO CODES
INSTITUTIONAL REVIEW BOARD (IRB/IEC).pptxRAHUL PAL
The International Council on Harmonisation (ICH) defines an institutional review board (IRB) as a group formally designated to protect the rights, safety and well-being of humans involved in a clinical trial by reviewing all aspects of the trial and approving its startup. IRBs can also be called independent ethics committees (IECs).
An IRB/IEC reviews the appropriateness of the clinical trial protocol as well as the risks and benefits to study participants. It ensures that clinical trial participants are exposed to minimal risk in relation to any benefits that might result from the research.
IRB/IEC members should be collectively qualified to review the scientific, medical and ethical aspects of the trial.
Per the FDA, an IRB/IEC should have:
At least five members.
Members with varying backgrounds.
At least one member who represents a non-scientific area (a lay member).
At least one member who is not affiliated with the institution or the trial site (an independent member).
Competent members who are able to review and evaluate the science, medical aspects and ethics of the proposed trial.
complete description of causality assessment with the definition of basic terminologies.& relation with an adverse event and adverse drug reaction, causality terms & assessment criteria.
Slides includes ADR monitoring process, Safety reporting, what is pharmacovigilance, types of ADR, basic terms in ADR monitoring, what is PvPI in India, role. stakeholders, ADR reporting form, Apps, Role of community Pharmacist in ADR monitoring, Importance of ADR monitoring, etc.
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
Spontenous adr reporting in india
PASSIVE survillence system, data assement
data aciqsition, data interpretation, what all information required in ADR form, WHEN TO REPORT
BLUE CARD,YELLOW CARD, WHO CODES
INSTITUTIONAL REVIEW BOARD (IRB/IEC).pptxRAHUL PAL
The International Council on Harmonisation (ICH) defines an institutional review board (IRB) as a group formally designated to protect the rights, safety and well-being of humans involved in a clinical trial by reviewing all aspects of the trial and approving its startup. IRBs can also be called independent ethics committees (IECs).
An IRB/IEC reviews the appropriateness of the clinical trial protocol as well as the risks and benefits to study participants. It ensures that clinical trial participants are exposed to minimal risk in relation to any benefits that might result from the research.
IRB/IEC members should be collectively qualified to review the scientific, medical and ethical aspects of the trial.
Per the FDA, an IRB/IEC should have:
At least five members.
Members with varying backgrounds.
At least one member who represents a non-scientific area (a lay member).
At least one member who is not affiliated with the institution or the trial site (an independent member).
Competent members who are able to review and evaluate the science, medical aspects and ethics of the proposed trial.
complete description of causality assessment with the definition of basic terminologies.& relation with an adverse event and adverse drug reaction, causality terms & assessment criteria.
Slides includes ADR monitoring process, Safety reporting, what is pharmacovigilance, types of ADR, basic terms in ADR monitoring, what is PvPI in India, role. stakeholders, ADR reporting form, Apps, Role of community Pharmacist in ADR monitoring, Importance of ADR monitoring, etc.
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
Extrapolation of in vitro data to preclinical and.pptxARSHIKHANAM4
Extrapolation of in vitro data to preclinical.
the topic is included in m.pharmacy 1st sem syllabus. which is essential for the study and that include the details about how you deal with the preclinical data that will help to decide the NOEAL and LOEAL, the humane dose of the drug can be calculated and further formation is also done.
To accomplish a desired systemic effect, drug molecules must reach the systemic circulation after extravascular administration. The percent of the taken dose that reaches intact to the systemic circulation is called “bioavailability, BA”. Absolute Bioavailability compares the BA of the active drug in systemic circulation following non-intravenous administration
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.
Assignment on Toxicokinetics- Toxicokinetic evaluation in preclinical studies, saturation kinetics Importance and applications of toxicokinetic studies. Alternative methods to animal toxicity testing.
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
Preclinical Toxicity Studies-Tool of Drug Discoverydynajolly
As per WHO “Drug is any substance or product that is used or is intended to be used to modify or explore physiological systems or pathological states for the benefit of the recipient”. Hence the prime objective of using any substance as a drug is that it must be beneficial for the humans. A large number of compounds are synthesized every year but they cannot be directly used in humans as drugs because no one knows or can predict the possible harmful effects of these compounds in humans. That is why to explore the complete pharmacological profile of these compounds and to ensure complete human safety they are first tested on animals before clinical use. Preclinical Studies thus can be defined as “Testing the newly discovered compound in animals with the objective of gaining information regarding the various aspects of the compound with respect to the biological systems so that the same can be extrapolated for the use of that compound in humans”. As the evaluation progresses undesirable compounds gets rejected at each step, so that only a few out of thousands reach the stage when administration to the humans is considered.
Pharmacovigilance and Pharmacoepidemiology journal accepts articles from different disciplines as below but not constrained to only these Pharmacovigilance signal, Pharmacovigilance data management, Design and development of drug, Principles of pharmacology, Quality system and pharmacovigilance, Pharmacovigilance softwares, Drug regulatory activities, Drug reactions and diagnosis, Reporting systems, Clinical trials and pharmacovigilance, Marketing surveillance, Pharmacovigilance ethics and regulations, Biomarkers and pharmacology , Concepts and trends in pharmacovigilance, Pharmaceutical medicines, Drug delivery systems, Statistics and data management.
Pharmacological Approach to Drug DiscoverySuhas Reddy C
For better understanding of students. This will give you a detailed explanation of Pharmacological approach. Contact me through comment section if you need any assistance in understating
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
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.
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
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!
We all have good and bad thoughts from time to time and situation to situation. We are bombarded daily with spiraling thoughts(both negative and positive) creating all-consuming feel , making us difficult to manage with associated suffering. Good thoughts are like our Mob Signal (Positive thought) amidst noise(negative thought) in the atmosphere. Negative thoughts like noise outweigh positive thoughts. These thoughts often create unwanted confusion, trouble, stress and frustration in our mind as well as chaos in our physical world. Negative thoughts are also known as “distorted thinking”.
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.
The Art Pastor's Guide to Sabbath | Steve ThomasonSteve Thomason
What is the purpose of the Sabbath Law in the Torah. It is interesting to compare how the context of the law shifts from Exodus to Deuteronomy. Who gets to rest, and why?
The Indian economy is classified into different sectors to simplify the analysis and understanding of economic activities. For Class 10, it's essential to grasp the sectors of the Indian economy, understand their characteristics, and recognize their importance. This guide will provide detailed notes on the Sectors of the Indian Economy Class 10, using specific long-tail keywords to enhance comprehension.
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How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
2. INTRODUCTION
• The various approaches to drug discovery include
1. Pharmacological
2. Toxicological
3. IND application
4. Drug characterization
5. Dosage form
• STEPS 1 and 2 constitute the PRECLINICAL STUDIES
3. PRECLINICAL TRIALS
• 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.
4. PHARMACOLOGICAL APPPROACHES
TO
DRUG DISCOVERY
• Pharmacology as an academic principle can be loosely defined
as the study of effects of chemical substances on living
systems.
• This definition is so broad that it encompasses all the aspects
of drug discovery, ranging from details of interaction between
drug molecule and its target to consequences of placing the
drug in the market
6. SELECTIVITY TESTING
• The selectivity testing mainly involves 2
main stages:
1. Screening for selectivity
2. Binding assays.
7. Screening for selectivity
The selectivity of a compound for a chosen
molecular target needs to be assessed because it
determines the potency of the drug.
A selected compound may bind to molecular targets
that are related or unrelated to the chosen molecular
target thereby causing unwanted side effects.
8. Binding assays
The aim of carrying out binding assays is to determine the
dissociation constant of the test compound as a measure of affinity
to the receptor.
These assays are generally done with membrane preparations made
from intact tissues or receptor expressing cell lines.
In most cases the assay measures the ability of the test compound to
inhibit the binding of a high affinity radio ligand which selectively
combines with the receptor in question.
9. PHARMACOLOGICAL PROFILING
• Pharmacological profiling refers to determining the
pharmacodynamic effects of a new compound. Either
on:
1. In vitro models: Cell lines or isolated tissues.
2. In vivo models: Normal animals, animal models of
disease*.
10. The aim of pharmacological profiling is to answer the
following questions:
Does the molecular and cellular effects measured in
screening assays actually give rise to the predicted
pharmacological effects in intact tissues and whole
animals?
Does the compound produce effects in intact tissues
or whole animals not associated with actions on its
principle molecular target?
11. • Is there a correspondence between potency of the drug at
molecular level, tissue level and the whole animal level.
• Do in vivo duration of action match up with the
pharmacokinetic properties of the drug.
• What happens if the drug is continuously or repeatedly
given to an animal over a course of days or weeks. Does
it loose its effectiveness or reveal effects not seen on
acute administration and whether there is any rebound
after effect when it is stopped.
12. In vitro profiling
In vitro profiling involves the studies on isolated tissues.
This technique is extremely versatile and applicable to studies
on smooth muscle* as well as cardiac and striated muscle,
secretory epithelia, endocrine glands, brain slices, liver slices.
In most cases tissue is obtained from a freshly killed or
anaesthetized animal and suspended in warmed oxygenated
physiological fluid solution.
13. Advantages
The concentration-effect relationship can be accurately
measured.
The design of the experiments are highly flexible allowing
measurement of:
• Onset and recovery of drug effects.
• Measurements of synergy and antagonism by other
compounds.
14. Disadvantages
• The tissues normally have to be obtained from small
laboratory animals, rather than humans or other
primates.
• The preparations rarely survive for more than a day,
so only short experiments are feasible.
15. In vivo profiling
In vivo profiling involves the testing on normal animal
models.
These methods are time consuming and very expensive.
They can be done on larger animals.
A particularly important role of in vivo experiments is to
evaluate the effects of long term drug administration on intact
organism.
16. SPECIES DIFFERENCES
• It is important to take species differences into account
at all stages of pharmacological profiling.
• The same target in different species will generally
differ in its pharmacological specificity.
• The growing use of transgenic animal models will
undoubtedly lead to an increase in animal
experimentation
17.
18. • Here there involves the use of animal models with the
human disease for which the drug has been prepared.
• There tests are done to answer a crucial question to
whether the physiological effects result in a
therapeutic benefit.
• Despite the range of diversity of animal models from
humans these tests will provide a valuable link to the
chain of evidence.
19. TYPES OF ANIMAL MODEL
Animal models of disease can be broadly classified into
1. Acute physiological and pharmacological models
2. Chronic physiological and pharmacological models
3. Genetic models
20. Acute physiological and pharmacological
model
• These models are intended to mimic certain aspects of the
clinical disorder. The examples are:
Seizures induced by electrical stimulation of brain as a
model of epilepsy
The hot plate for analgesic drugs as a model of pain.
Histamine induced broncho constriction as a model of
asthma.
21. Chronic physiological and pharmacological
model
• These models involve the use of drugs or physical
interventions to induce an ongoing abnormality similar to
clinical condition. The examples are:
The use of alloxane to inhibit insulin secretion as a model
of TYPE I diabetes mellitus.
Self administration of opiates, nicotine or other drugs as a
model of drug dependence.
22. Genetic animals
• These are transgenic animals produced by deletion or over
expression of specific genes to show abnormalities resembling
the human disease.
• The development of transgenic technology has allowed inbred
strains to be produced with the gene abnormality to be present
throughout the animals life.
• More recent developments allow more control over timing and
location of the transgenic effect.
23. VALIDITY CRITERIA IN CONTEXT TO
ANIMAL TESTING
An animal model produced in a lab can never exactly
replicate a spontaneous human disease state so certain
validity criteria have been set up, they are:
1. Face validity
2. Construct validity
3. Predictive validity
24. 1. FACE VALIDITY:
This validity refers to the accuracy with which the
model reproduces the phenomena( symptoms,
clinical signs and pathological changes)
characterizing the disease.
2. CONSTRUCT VALIDITY:
This refers to the theoretical rational with which the
model is based i.e. the extent to which the etiology
of the human disease is reflected in the model.
25. 3. PREDICTIVE VALIDITY:
• This validity refers to the extent to which the effect
of manipulations(e.g. drug treatment) in the model
is predictive of effects in the human disorder.
• This is the most important of the 3 as it is most
directly relevant to the issue of predicting
therapeutic efficacy.
26. SAFETY PHARMACOLOGY
• Safety pharmacology is the evaluation and study of
potentially life threatening pharmacological effects of
a potential drug which is unrelated to the desired
therapeutic effect and therefore may present a hazard.
• These tests are conducted at doses not too much in
excess of the intended clinical dose.
27. • Safety pharmacology seeks to identify unanticipated
effects of new drugs on major organ function(i.e.
secondary pharmacological effects).
• It is aimed at detecting possible undesirable or
dangerous effects of exposure of the drug in therapeutic
doses.
• The emphasis is on acute effects produced by single-
dose administration rather than effects on chronic
exposure as in toxicological studies.
28. TYPE PHYSIOLOGIAL SYSTEM TESTS
CORE BATTERY CENTRAL NERVOUS SYSTEM Observations on conscious animals
•Motor activity
•Behavioral changes
•Coordination
•Reflex responses
•Body temperatures
CARDIVASCULAR SYSTEM On anaesthetized animals
•Blood pressure
•Heart rate
•ECG CHANGES
Tests for delayed ventricular
repolarisation
RESPIRATORY SYSTEM Anaesthetized and conscious
•Respiratory rate
•Tidal volume
•Arterial oxygen saturation
29. TYPE PHYSIOLOGIC
SYSTEMS
TESTS
FOLLOW- UP
TESTS
CENTRAL NERVOUS
SYSTEM
•Tests on learning and speech
•More complex tests for changes in
behavior and motor function.
•Tests for visibility and auditory function
CARDIOVASCULAR
SYSTEM
•cardiac output
•Ventricular contractility
•Vascular resistance
•Regular blood flow
RESPIRATORY SYSTEM •Airway resistance and complince
•Pulmonary arterial pressure
•Blood gases
30. TYPE PHYSIOLOGIC
SYSTEM
TESTS
SUPPLEMENTARY
TESTS
RENAL FUNCTION •Urine volume, Osmolality, PH,
•Proteinuria
•Blood Urea/Creatinine
•Fluid/Electrolyte balance
AUTONOMIC NERVOUS
SYSTEM
•C.V.S, Gastrointestinal and respiratory
system responses to agonists and
stimulation of autonomic nerves.
GASTROINTESTINAL
SYSTEM
•Gastric secretion
•Gastric PH
•Intestinal motility
•Gastrointestinal transit time