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
Genetic polymorphism in drug transport and drug targets.pavithra vinayak
Genetic polymorphism in drug transport and targets.--pharmacogenetics
DRUG TRANSPORTER
Two types of transporter :
•ATP binding Cassette (ABC) – Found in ABCB, ABCD and ABCG family. Associated with multidrug resistance (MDR) of tumor cells causing treatment failure in cancer.
•Solute Carrier (SLC) – Transport varieties of solute include both charged or uncharged
P-glycoprotein
• ATP binding cassette subfamily B member- 1 (ABCB 1)
• Multidrug resistance protein 1 (MDR1)
• Transport various molecules, including xenobiotic, across cell membrane
• Extensively distributed and expressed throughout the body
Mechanism of Pglycoprotein
Substrate bind to P-gp form the inner leaflet of the membrane
ATP binds at the inner side of the protein
ATP is hydrolyzed to produce ADP and energy
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
breif notes on what is pharmacoepidemiology, why do we need pharmacoepidemiology, whats is its aim and its main applications, advantages and disadvantages
Challenges in implementation of GCP guidelines: By RxVichuZ!RxVichuZ
This work deals with Challenges in the Implementation of GCP guidelines. Its based on Clinical Research subject.
Do go through it.
Regards,
@ RxVichu! :)
Genetic polymorphism in drug transport and drug targets.pavithra vinayak
Genetic polymorphism in drug transport and targets.--pharmacogenetics
DRUG TRANSPORTER
Two types of transporter :
•ATP binding Cassette (ABC) – Found in ABCB, ABCD and ABCG family. Associated with multidrug resistance (MDR) of tumor cells causing treatment failure in cancer.
•Solute Carrier (SLC) – Transport varieties of solute include both charged or uncharged
P-glycoprotein
• ATP binding cassette subfamily B member- 1 (ABCB 1)
• Multidrug resistance protein 1 (MDR1)
• Transport various molecules, including xenobiotic, across cell membrane
• Extensively distributed and expressed throughout the body
Mechanism of Pglycoprotein
Substrate bind to P-gp form the inner leaflet of the membrane
ATP binds at the inner side of the protein
ATP is hydrolyzed to produce ADP and energy
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
breif notes on what is pharmacoepidemiology, why do we need pharmacoepidemiology, whats is its aim and its main applications, advantages and disadvantages
Challenges in implementation of GCP guidelines: By RxVichuZ!RxVichuZ
This work deals with Challenges in the Implementation of GCP guidelines. Its based on Clinical Research subject.
Do go through it.
Regards,
@ RxVichu! :)
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
Ethical guidelines in clinical research @ RxVichuZ!!! ;)RxVichuZ
This is my 85th document...deals with ethical guidelines in clinical research. They resemble GCP guidelines, in the aspect that they formulate special headings, that ought to be considered, when conducting clinical trials on human volunteers.
Statistical softwares used in pharmacoeconomics @ RxVichuZ!! :)RxVichuZ
This summarized outline deals with SOFTWARES USED IN PHARMACOECONOMIC STUDIES, their precise details, merits & summarized relevant applications.
With respect to PHARMACOEPIDEMIOLOGY & PHARMACOECONOMICS subject.
clinical and preclinical approaches to drug discovery.Here we mainly deals with preclinical approaches, ie. Pharmacological approach and toxicological approach
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.
Population pharmacokinetics is the study of the sources and correlates of variability in drug concentrations among individuals who are the target patient population receiving clinically relevant doses of a drug of interest
conversion from INTRAVENOUS TO ORAL DOSING----- design of dosage regimenpavithra vinayak
conversion from INTRAVENOUS TO ORAL DOSING----- TYPES OF IV TO PO THERAPY CONVERSIONS: MEDICATIONS INCLUDED IN AN IV TO PO CONVERSION PROGRAM: SELECTION OF PATIENTS FOR IV TO PO THERAPY CONVERSION: design of dosage regimen--clinical pharmacokinetics and therapeutic drug monitoring-- fifth pharm D notes
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
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
Safety pharmacology studies in drug developmentAnkita
In the given ppt we get idea about safety pharmacology studies. learn why safety pharmacology is important. concept of safety pharmacology, also get the knowledge from where safety pharmacology is originated
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
Ethical guidelines in clinical research @ RxVichuZ!!! ;)RxVichuZ
This is my 85th document...deals with ethical guidelines in clinical research. They resemble GCP guidelines, in the aspect that they formulate special headings, that ought to be considered, when conducting clinical trials on human volunteers.
Statistical softwares used in pharmacoeconomics @ RxVichuZ!! :)RxVichuZ
This summarized outline deals with SOFTWARES USED IN PHARMACOECONOMIC STUDIES, their precise details, merits & summarized relevant applications.
With respect to PHARMACOEPIDEMIOLOGY & PHARMACOECONOMICS subject.
clinical and preclinical approaches to drug discovery.Here we mainly deals with preclinical approaches, ie. Pharmacological approach and toxicological approach
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.
Population pharmacokinetics is the study of the sources and correlates of variability in drug concentrations among individuals who are the target patient population receiving clinically relevant doses of a drug of interest
conversion from INTRAVENOUS TO ORAL DOSING----- design of dosage regimenpavithra vinayak
conversion from INTRAVENOUS TO ORAL DOSING----- TYPES OF IV TO PO THERAPY CONVERSIONS: MEDICATIONS INCLUDED IN AN IV TO PO CONVERSION PROGRAM: SELECTION OF PATIENTS FOR IV TO PO THERAPY CONVERSION: design of dosage regimen--clinical pharmacokinetics and therapeutic drug monitoring-- fifth pharm D notes
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
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
Safety pharmacology studies in drug developmentAnkita
In the given ppt we get idea about safety pharmacology studies. learn why safety pharmacology is important. concept of safety pharmacology, also get the knowledge from where safety pharmacology is originated
safety pharmacology is the branch of pharmacology specializing in detecting and investigating potential undesirable pharmacodynamic effects of a new chemical on physiological functions .
the content of this presentation is as follows
- introduction
- definition
- history
- ICH - guidelines
- refrences
This guideline was developed to help protect clinical trial participants and patients receiving marketed products from potential adverse effects of pharmaceuticals, while avoiding unnecessary use of animals and other resources. This guideline provides a definition, general principles and recommendations for safety pharmacology studies
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.
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.
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
Similar to Pharmacological Approach to Drug Discovery (20)
For better understanding of students. This will give you a detailed explanation of IND APPLICATION. Contact me through comment section if you need any assistance in understating this topic.
Biological screening of herbal drugs: Introduction and Need for
Phyto-Pharmacological Screening, New Strategies for evaluating
Natural Products, In vitro evaluation techniques for Antioxidants, Antimicrobial and Anticancer drugs. In vivo evaluation techniques
for Anti-inflammatory, Antiulcer, Anticancer, Wound healing, Antidiabetic, Hepatoprotective, Cardio protective, Diuretics and
Antifertility, Toxicity studies as per OECD guidelines
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
Honest Reviews of Tim Han LMA Course Program.pptxtimhan337
Personal development courses are widely available today, with each one promising life-changing outcomes. Tim Han’s Life Mastery Achievers (LMA) Course has drawn a lot of interest. In addition to offering my frank assessment of Success Insider’s LMA Course, this piece examines the course’s effects via a variety of Tim Han LMA course reviews and Success Insider comments.
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?
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
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.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
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.
Model Attribute Check Company Auto PropertyCeline George
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Acetabularia Information For Class 9 .docxvaibhavrinwa19
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Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
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2. Introduction
Pharmacology is a scientific discipline that specialises in the mechanism of
action, uses and undesired effects of drugs.
Pharmacological studies should be conducted to support use of therapeutics in
humans.
In the early stages of drug development enough information may not be
available to rationally select study design for safety assessment. In such a
situation, a general approach to safety pharmacology studies can be applied.
3. Animal pharmacology testing provides the initial conformation that the
molecular targets is involved in a metabolic pathway or integrated physiological
process that is abnormal in the disease state.
Animal pharmacology studies allow the effects of the lead compound on the
disease process (Pharmacodynamics) to be correlated with the concentration of
compound need to achieve these effects (Pharmacokinetics).
4. If the results of the tests suggest potential beneficial activity, related compounds
are tested to see which version of the molecule produces the highest level of
pharmacological activity and demonstrates the most therapeutic promise, with the
smallest number of potentially harmful biological properties.
6. Unlike primary and secondary pharmacology studies that explore the mode of
action of the candidate drug and its effects related or unrelated to the therapeutic
target, respectively, Safety Pharmacology identifies the “potential undesirable
pharmacodynamic effects of a substance on physiological functions in relation to
exposure in the therapeutic range and above”
which are not identified by standard non-clinical toxicological studies.
SP studies are, therefore, performed to ensure the safety of clinical participants
in first in human (FiH) trials through improved decision-making in the selection
of lead candidate drugs.
7. 1. Research pharmacological studies:
Research pharmacological studies are conducted at the starting of a drug
development program. They need to be performed to GLP standards.
There are two types:
a) Primary research pharmacology studies
b) Secondary research pharmacology studies
8. a) Primary research pharmacology
studies
Primary actions are related to proposed therapeutic use.
These studies focus on the mechanism of action of drug and can be conducted in vitro
and in vivo.
Studies conducted in vitro include radioligand binding studies and focus on drugs
action on specific receptor sites
Studies conducted in vivo investigate the pharmacological action of the drug in animal
models.
9. b) Secondary research pharmacology
studies
Secondary actions focus on the overall pharmacological activity of the drug compound.
And also relates to the actions that occur which is not directly related to the proposed
therapeutic use.
This can be conducted in vitro and in vivo. In vitro studies investigate the binding of the
drug molecule with the non-target receptors.
In vivo studies investigate the general pharmacological actions in animal models.
10. 2. Safety pharmacology studies:
Safety pharmacology studies are studies that investigate potential undesirable
pharmacodynamic effects of a substance on physiological functions in relation to
exposure within the therapeutic range or above.
Safety pharmacology studies investigate potentially undesirable effects of the
drug compound.
They are conducted in animal models, that are single dose studies using
intended therapeutic dose.
11. In vitro studies should be designed to establish a concentration-effect
relationship. The range of concentrations used should be selected to increase the
likelihood of detecting an effect on the test system. The upper limit of this range
may be influenced by physicochemical properties of the test substance and other
assay specific factors.
In vivo safety pharmacology studies should be designed to define the dose-
response relationship of the adverse effect observed. When feasible, the time
course (e.g. onset and duration of response) of the adverse effect should be
investigated.
12. The essential safety pharmacology is to study the effects of the test drug on vital
functions. Vital organ systems such as cardiovascular, respiratory and central
nervous systems should be studied.
13. Examples
CVS blood pressure, heart rate, and the electrocardiogram.
CNS motor activity, behavioural changes, coordination, sensory and
motor reflex responses and body temperature
RS tidal volume and haemoglobin oxygen saturation should be
studied.
14. Supplemental Safety Pharmacology
Studies
required to investigate the possible adverse pharmacological effects that are not
assessed in the essential safety pharmacological studies and are a cause for
concern.
15. CVS ventricular contractility, vascular resistance and the effects of chemical mediators, their
agonists and antagonists on CVS
CNS learning and memory, electrophysiology studies , neurochemistry and ligand binding studies.
RS airway resistance, compliance, pulmonary arterial pressure, blood gases and blood pH.
Urinary
system
urine volume, specific gravity, osmolality, pH, proteins, cytology and BUN, creatinine and
plasma proteins estimation.
ANS binding to receptors relevant for the autonomic nervous system, and functional response to
agonist or antagonist responses in vivo or in vitro, and effects of direct stimulation of
autonomic nerves and their effects on cardiovascular responses
GIS gastric secretion, gastric pH measurement, gastric mucosal examination, bile secretion, gastric
emptying time in vivo and ileocaecal contraction in vitro.
Others Effects of the investigational drug on organ systems not investigated elsewhere should be
assessed when there is a cause for concern. For example dependency potential, skeletal
muscle, immune and endocrine functions may be investigated.
16. Safety pharmacology studies are
usually not required when;
Product is to be used for local application, e.g. dermal or ocular
The pharmacology of the investigational drug is well known
Systemic absorption from the site of application is low
Safety pharmacology testing is also not necessary, in case of a new derivative
having similar pharmacokinetics and pharmacodynamics.
For biotechnology-derived products that achieve highly specific receptor
targeting.
17. Timing Of Safety Pharmacology Studies In
Relation To Clinical Development
1. Prior To First Administration In Humans
The effects of an investigational drug on the vital functions listed in the essential
safety pharmacology should be studied prior to first administration in humans
2. During Clinical Development
Additional investigations may be warranted to clarify observed or suspected
adverse effects in animals and humans during clinical development
18. 3. Before applying for marketing Approval
Follow-up and supplemental safety pharmacology studies should be assessed prior
to approval unless not required, in which case this should be justified. Available
information from toxicology studies addressing safety pharmacology endpoints or
information from clinical studies can replace such studies.
19. 4. Application Of Good Laboratory Practices (GLP)
The animal studies be conducted in an accredited laboratory. Where the safety
pharmacology studies are part of toxicology studies, these studies should also be
conducted in an accredited laboratory.
20.
21. References
DRUG DISCOVERY AND CLINICAL RESEARCH - SK Guptha
https://www.fda.gov/ForPatients/Approvals/Drugs/ucm405382.htm
https://www.researchgate.net/profile/Dominic_Williams2/publication/23701632
5_Safety_pharmacology_-
_Current_and_emerging_concepts/links/59e07a4d45851537161225d5/Safety-
pharmacology-Current-and-emerging-concepts.pdf
https://prezi.com/g95fbzxyu6fi/various-approaches-to-drug-discovery/
New drug development –design methodology & analysis by J. RICK TURNER.