CLINICAL RESEARCH IS ONE WHICH MADE POSSIBLE , ORAGAN TRANSPLANT, MANAGE OF DIBETIS, ADDED YEAR OF AIDS PATIENT.
HOW WELL NEW APPROCHES AND WORK IN PEOPLE.
THE APPROACHES CAN BE MEDICAL, BEHAVIORAL, OR MANAGEMENT.
EACH STUDY ANSWER SCIENTIFIC QUESTION.
GENERAL INTRODUCTION OF CLINICAL RESEARCH
KEY POINTS AND CONCEPTUAL DEFINATION
DRUG DISCOVERY PROCESS
SOURCES OF DRUG DISCOVERY
PRECLINICAL STUDY
FOR MORE RELATED QUERIES CONTACT US ON- 9028839789
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Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Dr B Naga Raju
Presentation on Roles and Responsibilities of sponsor in conducting clinical trials as per GCP-ICH for pursuing a subject in the course of PharmD programme under RGUHS
Investigator: A person responsible for the conduct of the study at the trial site.
Investigator is a person responsible for the rights, health and welfare of the study subjects.
SAE REPORTING TIMELINE AND COMPENSATION 2019Shweta Lal
This presentation is based on New Drug and Clinical Trial Rule 2019 which was published in 19 march 2019. I have described chapter VI ( compensation) and Seventh Schedule including SAE reporting timeline in India.
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Dr B Naga Raju
Presentation on Roles and Responsibilities of sponsor in conducting clinical trials as per GCP-ICH for pursuing a subject in the course of PharmD programme under RGUHS
Investigator: A person responsible for the conduct of the study at the trial site.
Investigator is a person responsible for the rights, health and welfare of the study subjects.
SAE REPORTING TIMELINE AND COMPENSATION 2019Shweta Lal
This presentation is based on New Drug and Clinical Trial Rule 2019 which was published in 19 march 2019. I have described chapter VI ( compensation) and Seventh Schedule including SAE reporting timeline in India.
Origin and principles of international conference on harmonization- Good clin...AbhishekJoshi312
The ppt gives a basic information about ICH-GCP, how it originated , what led to the formation of ICH-GCP guidelines and what are the principles of the guidelines.
Role & responsibilities of a clinical research coordinatorRadhika Nagare
Clinical Research Coordinator (CRC) is a specialized research person working with and under the direction of the Principal Investigator .While the Principal Investigator(PI) is primarily responsible for the overall designing, conducting, and management of the clinical trial, the CRC supports, and coordinates the regular clinical trial activities and plays a crucial role in the conduct of the study. By doing these duties, the CRC works with the PI, sponsor ,department, and institution to support and provide guidance on every related aspects of the study.
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.
A sponsor in literal terms is defined as an individual or a company or an institution that takes the responsibility for the initiation, management and/or financing of a clinical study.
In case an investigator independently initiates and takes full responsibility for a trial, he/she automatically assumes the role of a sponsor.
Roles and Responsibilities of sponsor, CRO, and investigator MOHAMMEDSALEEMJM
This slide mainly includes Roles and responsibilities of sponsor CRO and Investigator in Ethical conduct of Clinical Research as per ICH GCP Guidelines
Required mainly for Regulatory affairs students
Origin and principles of international conference on harmonization- Good clin...AbhishekJoshi312
The ppt gives a basic information about ICH-GCP, how it originated , what led to the formation of ICH-GCP guidelines and what are the principles of the guidelines.
Role & responsibilities of a clinical research coordinatorRadhika Nagare
Clinical Research Coordinator (CRC) is a specialized research person working with and under the direction of the Principal Investigator .While the Principal Investigator(PI) is primarily responsible for the overall designing, conducting, and management of the clinical trial, the CRC supports, and coordinates the regular clinical trial activities and plays a crucial role in the conduct of the study. By doing these duties, the CRC works with the PI, sponsor ,department, and institution to support and provide guidance on every related aspects of the study.
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.
A sponsor in literal terms is defined as an individual or a company or an institution that takes the responsibility for the initiation, management and/or financing of a clinical study.
In case an investigator independently initiates and takes full responsibility for a trial, he/she automatically assumes the role of a sponsor.
Roles and Responsibilities of sponsor, CRO, and investigator MOHAMMEDSALEEMJM
This slide mainly includes Roles and responsibilities of sponsor CRO and Investigator in Ethical conduct of Clinical Research as per ICH GCP Guidelines
Required mainly for Regulatory affairs students
By Vaishnavi Nikte ( B pharmacy )
slides includes all about Clinical Research Pharmacovigilance & Phyto Research. Useful for pharmacy student as well as Clinical research field people also includes pharmacognosy basics for herbal drug discovery.
In vivo is the Latin word which means with in the living body.
When effects of various biological entities are tested on whole, living organism or cells, usually animals including humans and plants.
Animal testing and clinical trials are major elements of in-vivo research.
In vivo testing is often employed over in vitro because it is better suited for observing the overall effects of an experiment on a living subject in drug discovery.
example, verification of efficacy in vivo is crucial, because in vitro assays can sometimes yield misleading results with drug.
Harry Smith found that sterile filtrates of serum from animals infected with Bacillus anthracis were lethal for other animals, whereas extracts of culture fluid from the same organism grown in vitro were not.
In microbiology Once cells are disrupted and individual parts are tested or analyzed, this is known as in vitro.
In vitro studies within the glass, i.e., in a laboratory environment using test tubes, petri dishes, etc. Examples of investigations in vivo include: the pathogenesis of disease.
In vitro toxicology:-
The bridge exists between new drug discovery and drug development.-
Provide information on mechanism of action of a drug
Provides an early indication of the potential for some kinds of toxic effects, allowing a decision to terminate or to proceed further.
In vitro methods are widely used for:-
Screening and ranking chemicals
Get a platform for animal studies for physiological actions
Studying cell, tissue, or target specific effects
Improve subsequent study design
Advantages and Disadvantages:-
Faster than in vivo studies
Less expensive to run
Less predictive of toxicity in intact organisms
In vitro to in vivo extrapolation (IVIVE) refers to the qualitative or quantitative transposition of experimental results or observations made in vitro to predict phenomena in vivo, biological organisms.
The problem of transposing in vitro results is particularly acute in areas such as toxicology where animal experiments are being phased out and are increasingly being replaced by alternative tests.
Results obtained from in vitro experiments cannot often be directly applied to predict biological responses of organisms to chemical exposure in vivo.
Therefore, it is extremely important to build a consistent and reliable in vitro to in vivo extrapolation method.
Two solutions are now commonly accepted:
Increasing the complexity of in vitro systems where multiple cells can interact with each other in order recapitulate cell-cell interactions present in tissues (as in "human on chip" systems).
Using mathematical modeling to numerically simulate the behavior of a complex system, whereby in vitro data provides the parameter values for developing a model.
The two approaches can be applied simultaneously allowing in vitro systems to provide adequate data for the development of mathematical models. To comply with push for the development of alternative testing methods.
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.
Introduction
History
How are new drug discovered?
Bioinformatics in drug discovery
Tools for drug discovery
Successful drug
Software for drug discovery
Conclusion
References
Pristyn Research Pvt Ltd is a contract research organization specialize in providing tailored clinical research and pharmaceutical development solutions to both the inventor and pharmaceutical industries. With a legacy of years of excellence, we have consistently empowered global enterprises to elevate their regulatory and clinical research endeavours, delivering impactful and high-quality data. Pristyn Research is a professional and reliable name in the pharmaceutical and research industry. We strive to produce validated medical data for research & dedicated professionals.
Our comprehensive suite of services extends beyond clinical trials and operational support. We are your one-stop destination, offering medical writing, regulatory guidance, and scientific research services. We provide a complete package, spanning the journey from drug discovery to regulatory approval, including crucial tech transfer processes. Our impressive track record boasts numerous successfully completed clinical studies and research projects, encompassing vital areas such as medical device testing. We've been instrumental in helping numerous sponsors navigate the complexities of regulatory approvals, ensuring their innovations reach the market.
Pristyn Research is a legally established corporation under the laws of India and proudly bears the registered trademark "Pristyn Research®." Notably, we have recently integrated the esteemed "Pristyn Research Solutions," a renowned leader in corporate training for research and development. Our international affiliations and regional government approvals for training programs underscore our commitment to excellence in education and development. Our vast network of representatives and affiliates spans across various sectors, including corporate, public, private organizations, and professional bodies. This expansive reach reflects our dedication to fostering collaboration and innovation within the clinical research and development domain. In summary, Pristyn is your trusted ally on the journey of scientific discovery and innovation. With a rich history of accomplishments and a forward-looking approach, we are poised to continue making significant contributions to the world of research and pharmaceuticals, consistently raising the bar for excellence.
COMMON REGULATORY AFFAIRS JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated in 2022!Pristyn Research Solutions
COMMON REGULATORY AFFAIRS
JOB INTERVIEW QUESTIONS WITH
ANSWERS By Pristyn Research-Updated 2022.
A quick Job interview short guide For Pharma and all
Life science jobseekers.
info.pristynresearch.com
www.pristynresearch.com
9028839789 | 8999717656
All Medical | Biotech |Micro |B.Sc., M.Sc.
PAN India DRA companies
list alphabetically
PHARMACOVIGILANCE COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated IN 202...Pristyn Research Solutions
Quick Job interview short guide For Pharma and all Life science jobseekers.All Medical | Biotech |Micro |B.Sc., M.Sc.
These are the commonly asked questions with their answers asked in job interviews. The file was updated in 2022.
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
FACEBOOK- https://www.facebook.com/pristynsolutions
INSTAGRAM- https://www.instagram.com/pristyn_res...
TWITTER- https://twitter.com/Pristynresearch
SLIDESHARE- https://www.slideshare.net/azherkhan5916
LINKEDIN- https://www.linkedin.com/in/pristyn-research-191072119/
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4, Opposite To Expert Global, Garware Stadium Road, Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 9028839789
Sample Questions are:
What is Pharmacovigilance (PV)?
What are the objectives of PV?
What is MedDRA?
WHAT ARE THE Role of Drug Safety
Associate?
What should narratives consist of?
What are Data assessments in PV?
Which products are covered by PV?
Methods of signal detection?
Why PV is required after clinical
trial?
What is an Adverse Drug Event (ADE)?
What
is the minimum criterion required
for a valid case according to WHO?
When
do you consider an event to be
serious?
What do you mean by causality?
Types of
Unsolicited reports
Sources of Solicited Reports
Name the core regulatory bodies
What is Volume 9A
What do you know
about E2a, E2b and E2c guidelines?
When do you consider a case to be medically confirmed?
What is CemFlow?
What is the yellow card in PV?
What are Comorbid conditions?
What is a medication error?
What is a signal?
Rechallenge
Dechallenge
What are WHO ART, WHO DD and MedDRA and the difference between them?
What is SUSAR?
Adverse Drug Reaction (ADR)
Effectiveness/risk
harm
Essential medicines
Frequency of ADRs
Individual Case Safety Report
ADR Reporting process in PV
VigiFlow
VigiMed
ABBOTTS
COGNIZANT
I 3 GLOBAL DRUG
SAFETY
LAURUS LABS
PARAXEL
SRISTEK
ACCENTURE
CREST.
I GATE PATNI
COMPUTERS
MAHINDRA
SATYAMBSG
PIRAMAL
SUN
PHARMA
ALEMBIC
DIAGNOSEAR
CH
ICON
MAKROCARE
PPD
SYMOGEN
APC PHARMA.
DR REDDY’S
iMEDGlobal,
MANKIND
QUANTUM
SOLUTIONS
SYNOGEN
APCER
ECRON
ACUNOVA
IMS HEALTH
MEDHIMALAYAS
QUINTILES
TAKE
SOLUTIONS
APCER
EMCURE
INC RESEARCH
MEDPACE.
SCIFORMIX
RATIOPHARM
TCS
ASTRAZENECA
FDC
Infocorp
Soft
Solutions
MICRO LABS
RX MD
THOMSON
REUTERS
AUROBINDO
FORTIS
HEALTH CARE
INVENTIVE
MSD (MERCK)
SANTHA
BIOTECH
USV
LIMITED
BESTOCHEM
G7 INFOTECH
IPCA
LABORATORIES
NEKTAR
THERAPEUTICS
SCIFORMIX.
VIMTA LABS
BIOCAD
GENPACT
IPLEX
NORWICH
CLINICAL SERVICES
SHANTHA
BIOTECHNICS
WIPRO
BIOCON
GRANULES
JUBILIANT
BIOSYS NOVARTIS
SIRO
CLINPHARM
WNS
BIOLOGICAL E.
LTD
GVK
KINAPSE
NOVO NORDISK
SP softtech
WOCKHARD
T
BLUEFISH
HCL
LAMBDA
OMNICARECLINICA
L RESEARCH
SRI KRISHNA
PHARMA
4C
Pharma
Solutions
These are the commonly asked questions with their answers asked in any job interviews. The file is updated in 2022.
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
FACEBOOK- https://www.facebook.com/pristynsolutions
INSTAGRAM- https://www.instagram.com/pristyn_res...
TWITTER- https://twitter.com/Pristynresearch
SLIDESHARE- https://www.slideshare.net/azherkhan5916
LINKEDIN- https://www.linkedin.com/in/pristyn-research-191072119/
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4, Opposite To Expert Global, Garware Stadium Road, Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
Sample Questions are:
Tell me about yourself?
What are your Career Goals?
Why have you been unemployed for such a long time?
Are you a team player?
Describe your management
style?
What irritates you about co
workers?
What position do you prefer
while in a team working for
project?
Do you consider yourself
successful?
what are your strengths?
what are your weaknesses?
why you left your previous job?
why we should hire you?
are you a complete fresher?
Tell me about your ability to work under pressure?
How long would you expect to work for us if hired?
What are your expectations from a job?
How do you see yourself 5 years from now?
What are your Salary Requirements?
What will you do if we reject you?
DO you have any questions for Us?
Answer it like: If selected: Yes I do, when can I join?
If rejected: Yes I do, rejection is an
opportunity to learn. I will request
you to kindly tell me the reason why I am being rejected today? I will work on my shortcomings and may one day be a part of your
organization.
What is scientific research writing?
Answer: It is the technical writing that scientists do to communicate their research to others [1].
What is a research manuscript?
Answer: A systematic inquiry document that entails collection of data; documentation of critical information; and analysis and interpretation of that data/information, in accordance with suitable methodologies set by specific professional fields and academic disciplines [2].
What is a review article?
Answer: A literature review article is a comprehensive summary of previous research on a topic. It is assumed that by mentioning a previous work in the field of study, that the author has read, evaluated, and assimiliated that work into the work at hand [3].
What is peer review paper?
The peer review paper is a validation of academic work, helps to improve the quality of published research, and increases networking possibilities within research communities [4].
What is meta-analysis?
Answer: A subset of systematic reviews; a method for systematically combining pertinent qualitative and quantitative study data from several selected studies to develop a single conclusion that has greater statistical power [5].
What dissertation?
Answer: A thesis is a hypothesis or conjecture. A PhD dissertation is a lengthy, formal document that argues in defense of a particular thesis. Two important adjectives used to describe a dissertation are ``original'' and ``substantial.'' The scientific method means starting with a hypothesis and then collecting evidence to support or deny it [6].
What are journals?
Answer: A research journal is a periodical that contains articles written by experts in a particular field of study who report the results of research in that field [7].
What does publisher mean?
Answer: Authors and publishers will generally have a publishing agreement (sometimes referred to as an author or licence agreement) in place when a work is published [8].
What is ISSN number?
Answer: An ISSN is an 8-digit code used to identify newspapers, journals, magazines and periodicals of all kinds and on all media–print and electronic [9].
What is volume of a journal?
jobs
INTERVIEW
SOFTSKILLS
BODY LANGUAGE
EYE CONTACT
POSITIVE ATTITUDE
SITTING POSTURE
SMILE
SELF CONFIDENCE
PUBLIC SPEAKING
GOOD DECISION
TIME MANAGEMENT
PUNCTUALITY
PROFESSIONALISM
RESPECT
RESPONSIBILITY
SKIN & BODY CARE
Make-up Hygiene
jobs
INTERVIEW
SOFTSKILLS
BODY LANGUAGE
EYE CONTACT
POSITIVE ATTITUDE
SITTING POSTURE
SMILE
SELF CONFIDENCE
PUBLIC SPEAKING
GOOD DECISION
TIME MANAGEMENT
PUNCTUALITY
PROFESSIONALISM
RESPECT
RESPONSIBILITY
SKIN & BODY CARE
Make-up Hygiene
SYNTHESIS, CHARACTERIZATION, AND STUDY OF ELECTRICAL
CONDUCTIVITY AND THERMOGRAVIMETRIC ANALYSIS OF
CONDUCTING POLYMER COMPOSITES WITH FLY ASH
- A Ph.D. PRE SUBMISSION SEMINAR-
Communication and Soft Skills in Pharma industry are most important to fill the vacuum created due to lack of facilities and guidance during the degree course. To prove the power of personality, Professionalism, Sovereignty, and Excellence in all walks of life for yourself and thus strengthen the shining future of your career and our Country.
NEW DRUG DEVELOPMENT
WHAT DOES DRUG MEAN?
TRADITIONAL SYSTEM OF MEDICINES
NEW DRUG DEVELOPMENT PROCESS
PHASES OF CLINICAL RESEARCH
OVERVIEW OF EACH PHASE
PHASE-0
PHASE-1
PHASE-2
PHASE-3
PHASE-4
CONSIDERATION BEFORE STARTING CLINICAL RESEARCH
AIMS AND OBJECTIVES OF EACH PHASES
.
.
.
FOR MORE RELATED QUERIES CONTACT US ON- 9028839789
FOR ENROLLMENT IN NEXT BATCH CONTACT ON ABOVE MENTIONED NUMBER
https://www.youtube.com/watch?time_continue=4&v=F4jiJD0O8T8
NEW DRUG DEVELOPMENT
Clinical Research - Phases
New Drug Development Process
CONTENT OF INDA
CONTENT OF NDA
.
.
.
FOR MORE RELATED QUERIES CONTACT US ON 09028839789
FOR ENROLLMENT IN NEXT BATCH KINDLY CONTACT US ON THE ABOVE MENTIONED CONTACT NUMBER
http://pristynresearch.com/
ETHICS COMMITTEE
MEMBERS OF ETHICS COMMITTEE
SOME ETHICS COMMITTEE AROUND THE WORLD
What authority does EC/IRB have?
.
.
.
FOR ENROLLMENT CALL US ON - 9028839789
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
FACEBOOK- https://www.facebook.com/pristynsolutions
INSTAGRAM- https://www.instagram.com/pristyn_res...
TWITTER- https://twitter.com/Pristynresearch
SLIDESHARE- https://www.slideshare.net/azherkhan5916
LINKEDIN- https://www.linkedin.com/in/pristyn-research-191072119/
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4 ,Opposite To Expert Global, Garware Stadium Road , Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS ...Pristyn Research Solutions
THESE ARE SOME COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS INTERVIEW
FOR ENROLLMENT CALL US ON - 9028839789
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
FACEBOOK- https://www.facebook.com/pristynsolutions
INSTAGRAM- https://www.instagram.com/pristyn_res...
TWITTER- https://twitter.com/Pristynresearch
SLIDESHARE- https://www.slideshare.net/azherkhan5916
LINKEDIN- https://www.linkedin.com/in/pristyn-research-191072119/
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4 ,Opposite To Expert Global, Garware Stadium Road , Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
These are some frequently asked questions in Pharmacovigilance Interview & its Preparation.
"HANDS IN HANDS LEARNING"
FOR ENROLLMENT-
CONTACT US ON-
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4 ,Opposite To Expert Global, Garware Stadium Road , Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
DRUG AND COSMETIC ACT -
For more information regarding PHARMACOVIGILANCE, CLINICAL RESEARCH, CLINICAL DATA MANAGEMENT & DRUG REGULATORY AFFAIRS kindly contact us on 9028839789
PHARMACOVIGILANCE TERMINOLOGIES ASKED IN INTERVIEWS-
For more information regarding PHARMACOVIGILANCE, CLINICAL RESEARCH, CLINICAL DATA MANAGEMENT & DRUG REGULATORY AFFAIRS kindly contact us on 9028839789
DRUG ACTION
For more information regarding PHARMACOVIGILANCE, CLINICAL RESEARCH, CLINICAL DATA MANAGEMENT & DRUG REGULATORY AFFAIRS kindly contact us on 9028839789
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
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Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
2. CONTENT
1. GENERAL INTRODUCTION OF CLINICAL RESEARCH
2. KEY POINTS AND CONCEPTUAL DEFINATION
3. DRUG DISCOVERY PROCESS
4. SOURCES OF DRUG DISCOVERY
5. PRECLINICAL STUDY
4. IN 1754, surgeon James Lane; he discovered
that health save life. Also studied investigation
on SMALL POX, POLIO and YELLOW FEVER.
IN 1946, British Epidemiologist SIR AUSTIN
BRAND HILL; he done trail for TB patient put
patient into experimental and control group
randomly.
First trial with proof which predicts
streptomycin as antituberculatic drug.
6. PEOPLE WHO TAKES PART IN
CLINICAL TRIAL
CAN CONTRIBUTE KNOWLEDGE HOW DISEASE
PROGRESS
PARICIPANTS HAVE ASSESS TO PROMISSING
APPROACHES OFTEN NOT AVAILABLE OUTSITE
THE TRIAL SETTING
7. PARTICIPANTS RECEIVE CAREFUL MEDICAL
ATTENTION FROM A RESEARCHER TEAM OF
DOCTOR AND OTHER HEALTH PROFESSIONAL.
PARTICIPANTS MAY BE THE FIRST TO BENEFIT
FROM THE STUDY.
RESULT FROM THE STUDY MAY HELP OTHERS
FROM STUDY.
8. DRUG, VACCINE OR OTHER INTERVENTION
BEIGN STUDIED MAY BE MORE EFFECTIVE AND/
OR EFFICIOUS THAN STANDARD APPROACH.
9. KEY POINTS AND CONCEPTUAL
DEFINATION
1. CONTROL GROUP
2. RANDOMIZATION
3. BLIND STUDY
4. INCLUSION AND EXCLUSION CRITERIA
5. END POINT
6. SAMPLE SIZE
10. 7. ERROR
8. MULTICETER TRIAL
9. SUBSEQUENTIAL STUDY
10. META ANALYSIS
11. COHORT STUDY
12. CASE CONTROL HISTORY
11. CONTROL GROUP
A GROUP OF SUNJECTS WHICH RECEIVE
NO TRATMENT, A STADARD TREATMENT
OR PLACEBO.
12. RANDOMIZATION
A PROCESS OF ASSIGNING TRIAL SUBJECT
TO TREATMENT OR CONTROL GROUPS USING
AN ELEMENT OF CHANCE TO DETERMINE THE
ASSIGMENT IN ORDER TO REDUCE BIAS.
13. BLIND STUDY
THE STUDY IN CLINICAL TRAIL IN WHICH
INVESTIGATOR, PARTICIPANTS OR ANYONE
ASSESSING THE OUTCOME IS UNWARE OF
TRATMENT ASSIGNMENT.
IT IS USED TO REDUCE POTENTIAL BIAS.
14. INCLUSION AND EXDLUSION CRITERIA
INCLUSION CRITERIA IS A PROTOCOL THAT PROSPECTIVE
SUBJECTS MUST TO BE PARTICIPATE IN THE STUDY.
EXCLUSION CRITERIA IS A PROTOCOL ANY ONE OF WHICH
IS NOT ELIGIBLE FOR THE PARTICIPATION IN STUDY.
15. END POINT
THE END POINT IS FINAL RESULT FROM THE STUDY.
END POINT OF STUDY ARE PRIMARY AND SECONDARY.
WHICH MAY INCLUDES CURE, DEGREE OF IMPROVEMENT,
SYMPTOMS RELEIF, SURROGATE MARKER, AVOIDANCE OF
COMPLICATION, QUALITY OF LIFE, SURVIVAL, ETC.
16. MULTICENTER TRIAL
A CLINICAL TRIAL CONDUCTED ACCORDING TO
SAME PROTOCOL BUT AT MORE THAN ONE SITE
AND THERE FORE CARRIED OUT BY MORE THAN
ONE INCESTIGATOR.
17. SEQUENTIAL TRIAL
THIS DESIGN ATTEMPT TO DETECT A SIGNIFICANT RESULT AS SOON AS IT IS ACHIVED, MINIMIZING THE
NUMBER OF SUBJECTS.
TRIAL CONDUCTED ON MATCHED PAIRE OF SUBJECT AND IS SCORED AS ‘A’ IS BETTER THAN ‘B’ OR ‘B’
IS BETTER THAN ‘A’.
APPLICABLE TO DRUGS OR DISESASE IN WHICH CLINICAL END POINT IS ACHIVED QUICKLY AND
COMPARISION ARE POSSIBLE.
18. META ANALYSIS
THIS IS AN EXERCISE IN WHICH DATA FROM SIMILARLY CONDUCTED RANDOMIZED
CONTROL CLINICAL TRIALS WITH SAME DRUG( OR CLASS OF DRUG(S) EXAMINING, THE
SAME CLINICAL END POINT(S) IS POOLED TO BRING OUT OVERALL BALANCE OF EVIDENCE BY
ENLARGING NUMBER OF TEST AND CONTROL SUBJECTS AND INCREASING THE
SIGNIFICANCE AND POWER OF CONCLUSION.
19. COHORT STUDY
STUDY OF GROUP OF INDIVIDUAL, SOME OF
WHOME ARE EXPOSED TO A VARIABLE OF INTEREST,
IN WHICH SUBJECT ARE FOLLOWED OVERTME.
COHORT STUDY MAY PROSPECTIVE /
RETROSPECTIVE.
20. CASE CONTROL HISTORY
THIS TYPE OF OBSERVATIONAL STUDY IS USED MAINLY TO
REVEAL ASSOCIAON OF SUSPECTED RARE ADVERSE EVENT
WITH THE USE OF PERTICULAR DRUG.
CASES OF SUSPECTED ADVERSE EVENT ARE COLLECTED
FROM HOSPITAL RECORD OR DISEASE REGESTRIES.
22. DRUG
ACCORDING TO USP; “AN ARTICLE INTENDED FOR USE IN DIGNOSI,
TREATMENT, MITIGATION, CURE OR PREVENTION OF DISEASE”.
ACCORDING TO WHO, IN 1996; “DRUG IS ANY SUBSTANCE OR
PRODUCT THAT IS USED OR INTENDED TOMODIFY OR EXPLORE
PHYSIOLOGICAL OR PATHOLOGICAL STATES FOR THE BENEFITS OF
RECIPIENT”.
25. PLANT SOUCES:
OLDEST SOURCES OF MEDICINE.
THIS FIRST NATURAL SOUCES USED AS MEDICINE.
OBTAINED FROM TRADITIONAL SYSTEM OF
MEDICINE.
AYURVEDIC SYSTEM OF MEDICINE BASED ON
PLANT SOURCES.
EXAMPLES;
PLANT SOURCE ACTIVE DRUG
OPIUM MORPHINE
EPHEDRA EPHEDRINE
CINCHONA QUININE
BELLADONA ATROPINE
26. MINERALS:
IRON, CALCIUM SALTS ETC ARE THE SOURCES
OBTAINED FROM THE MINERAL SORCES MEDICINE.
MICROORGANISM:
MARINE:
ANIMAL:
27. CHEMICAL SYNTHESIS
DEBUTE IN 19th CETURY & NOW LARGEST IS
SOURCE.
THIAZIDE DIRUTICS FROM ACETAZOLIMIDE, TRICYCLIC ANTIDEPRESENT
FROM PHENOTHOZINE.
SALBUTAMOL B2 AGONIST B BLOKER BY MODIFYING
STRUCTURE.
EXCEPTION ARE, BARBTURATE AND CPM; SERENDEPITIOUSLY.
SO NOW BEST APPROACH FORCLINICAL RESEARCH DEVELOPMENT
28. RATIONAL SOURCES
AIMED AT MITIGATION THE DEARRAGEMENT CAUSED BY
DISEASE.
THIS DEPENDS ON PHYSIOLOGICAL, BIOCHEMICAL,
PATHOLOGICAL AND IDENTIFICATION OF SPECIFIC RECEPTOR
TARGET FOR DRUG ACTION SUCH AS H+K+ATPase ENZYME OR
GLYCOPROTIEN IIa/ IIIb RECEPTOR.
DOPAMINE DERIVATIVE LEVODOPA IN PARKINSONISM
29. MOLECULAR MODELING
ADVANCE IN PROTEIN CHEMISTRY AND COMPUTER ADDED
ELUCIDATION OF THREE DIMENTIONAL STRUCTURE OF KEY
RECEPTOR, ENZYME, ETC. HAS PERMITTED DESIGNING OF
TARGETED COPMOUND.
EXAMPLE; SELECTIVE COX-2 INHIBITOR PROMOTED BY
COMPARATIVE CONFUGARATION OF COX-1 AND COX-2 ENZYME.
30. COMBINATORY CHEMISTRY
CHEMICAL GROUP ARE COMBINE IN RANDOM
MANNER TO YIELD INNUMERABLE COMPOUND
AND SUBJECTED TO HIGH-THROUGHPUT
SCREENING ON CELLS, GENETICALLY, ENGINEEERED
MICROBES, RECEPTOR, ENZYME, ETC.
ASK TO SIR?
31. BIOTECHNOLOGY
SEVERAL DRUG PRODUCED BY RECOMBINANT DNA
TECHNOLOGY.
EXAMPLE; HUMAN GROWTH HARMONE, HUMAN
INSULIN.
SOME MONOCLONAL ANTIBODIES HAVE INTRODUCED AS
DRUG.
34. SYNTHESIS OF COMPOUND
SERENDIPITY; SUDDENLY DISCOVERY OF MOLECULE
SYNTHESIS ALSO CARRIED ACCORDING TO SITUATION,
DEMAND.
SERENDIPITY; PENECILINE
SYNTHESIS; ZIDOVUDINE
35. TARGET IDENTIFICATION & VALIDATION
SELECTION OF TARGET SITE FOR WHICH DRUG/ DEVICE IS GOING TO
PREPARE.
EXAMPLE; HIV(STAGES), CANCER (ORAL---)
VALIDATION OF PERTICULATE IS CARRIED TO ENSURE.
36. HIGH THROUGHPUT SCREENING
DEVELOPMENT OF SUBDISCIPLINE OF DRUG DISCOVERY
DEDICATED TO RAPID EVALUATION OF LARGE NUMBER OF
PURE COMPOUND THAT NATURALL PRODUCT EXTRACT FOR
VERY SPECIFIC BIOLOGICAL ACTIVITIES, USUALLY BASED ON
INTERACTION WITH SELECTED ENZYME OR RECEPTOR;
REFERRED AS HTS.
37. LEAD IDENTIFICATION
ONCE TARGET HAS SELECTED, NEXT STEP IS TO INDETIFICATION
OF NOVEL COMPOUNDS THAT INTERACT WITH ITS HIGH POTENCY,
EFFICACY AND SECTIVITY.
AFFINITY; ABILTY TO BIND TIGHTLY TO IT’S TARGET.
EFFICACY; ABILTY OF LIGANDS TO OBTAIN EFFECT ON IT’S
TARGETE, & AND CAN MEASURE AS BIOCHEMICAL AND
PHYSIOLOGICAL RESPONSE.
38. LEAD OPTIMIZATION
POTENTIAL DRUG REQUIRE MANY ATTRIBUTS.
BIOAVILABLE, CHEMICALLY STABLE, METABOLICALLY
STABILE.
FOR INSTACE, ONE MAY ACCEPT COMPOUND WITH LESS
POTENCY THAN OTHER IF IT HAS OTHER
PHARMACOKINETICS PROPERTIES.
40. SCREENING TEST
TEST ON ISOLATED
ORGAN
TEST ON BACTERIAL
CULTURE
ANIMAL TESTING
GENERAL
OBSERVATION TEST
CONFIRMATORY TEST
& ANALOGOUS
ACTIVITIES
MECHANISM OF
ACTION
SYNTHETIC
PHARMACOLOGY
QUANTITATIVE TEST PHARMACOKINETIC TOXICITY DOCUMENTATION
JOURNEY OF PHASE I
41. SCREENING TEST
THESE ARE SIMPLE AND RAPIDLY PERFORM TEST TO
INDICATE PRESENCE OR ABSENCE OF PERTICULAR
PHARMACODYNAMIC ACTIVITY OF THAT IS SOUGHT FOR
EXAMPLE; ANLAGESIC, ANTITB, ANTIRETROVIRAL, ETC.
42. TEST ON ISOLATED ORGANS, BACTERIAL
CULTURE
THESE ARE ALSO PRILIMINARY TEST PERFORMED ON EITHER
ON ISOLATED ORGAN, BACTERIAL CULTURE OR BOTH TO
DETERMINE THE SPEFIC ACTIVITY OF COMPOUND.
SUCH AS ANTIHISTAMINIC, VASODILATOR,
ANTIBACTERIAL, ETC.
43. ANIMAL TESTING
THESE ARE THE TEST WHICH PERFORMED ON ANIMAL MODEL.
FOR PERFORMING SUCH TEST APPROVAL OF RELATED
AUTHORITY REQUIRED WHICH PROVIDES THE GOOD LABORATORY
PRACTICES FOR THE TEST.
ANIMAL MODEL USED IN THE TEST ARE; RATS, MOUSE, GENIA
PIG, ETC.
44. GENERAL OBSERVATIONAL TEST
PERFORMED EITHER IN BEGINNING(IN CASE OF TOTAL NOVEL
COMPOUNDS) OR AFTER DETECTION OF USEFUL ACTIVITY IN
SCREENING TEST, DRUG IS INJECTED TO TRIPLING DOSES TO SMALL
GROUP OF ANIMALS WHICH ARE OBSERVED FOR OVERT EFFECTS.
PRIMARY CLUES ARE DROWN AT THE PROFILE OF EFFECTS
OBSERVED.
45. CONFIRMATORY TEST AND
ANOLOUGE ACTIVITIES
COMPOUNDS FOUND ACTIVE ARE TAKEN UP
DETAILED CHARACTERIZE THE ACTIVITY.
OTHER RELATED ACTIVITIES, EXAMPLE
ANTIPYRETIC AND ANTI- INFLAMATORY
ACTIVITIES IN ANALGESIC.
46. MECHANISM OF ACTION
THE MECHANISM BY WHICH DRUG ACTS IN THE BODY.
THESE ATTEMPT ARE MADE TO FIND OUT MECHANISM
OF ACTION OF DRUG WHETHER IT IS AN ANTIHYPERTENSIVE
IS AN ALFA BLOBKER/ BETA BLOKER/ CALCIUM CHANEL
BLOKER/ ACE INHIBITOR/ CENTRALLY ACTING.
THOUGH EXACT MAO OF DRUG IS NOT UNDERSTOOD YET.
47. SYNTHETIC PHARMACOLOGY
SYNTHETIC PHARMACOLOGY IS BASED ON THE FINDING
OF THE ACTION OF DRUG IN THE SYSTEM OF BODY.
IRESPECTIVE ACTION OF DRUG, ITS EFFECT ON MAJOR
ORGAN SYSTEMS SUCH AS NERVOUS, CARDIOVASCULAR,
RESPIRATORY, RENAL, GI ARE WORKED OUT.
48. QUANTATIVE TEST
THE RESPONSE RELATIONSHIP, MAXIMAL
EFFECT AND COMPARATIVE EFFUCACY WITH
EXISTING DRUG IS DETERMINED.
49. PHARMACOKINETICS
THE STUDY OF ADME; THAT WHAT DRUG DO TO BODY.
THE ANSORPTION, TISSUE DISTRIBUTION, METABOLISM,
SITE OF EXCREATION, VOLUME OF THE DESTRIBUTION AND
HALF LIFE OF THE DRUG ARE QUANTIFIED.
50. TOXICITY
TOXICUTY REFERED AS, HARM TO BODY.
AIM IS TO DETERMINE SAFETY OF COMPOUND.
TOXICITY PRODUCED BY DRUG MAY BE, ACUTE TOXICITY,
CHRONIC TOXICITY, SUB ACUTE TOXICITY, SPECIAL LONG
TERM TOXICITY, REPRODUCTION AND TERATOGENECITY,
CARCINOGENECITY.
51. ACUTE TOXICITY:
SINGLE ESCALATING DOSE ARE GIVEN TO SMALL GROUPS OF ANIMALS
THAT ARE OBSERVED FOR OVERT EFFECTS AND MORTALITY FOR 1-3
DAYS.
LD50 IS CALCULATED
SUB ACUTE TOXICITY:
ORGAN TOXICITY IS EXAMINED BY HISTOPATHOLOGY ON ANIMAL.
REPETATED DOSE ARE GIVEN FOR 2-12 WEEKS DEPENDING ON
DURATION ON INTENDED TREATMENT IN MAN.
DOSE ARE SELECTED ACCORDING TO ED50 AND LD50.
ANIMAL ARE EXAMINED FOR OVERT EFFECTS, FOOD INTAKE, BODY
WEIGHT, HAEMATOLOGY, ETC AND ORGAN TOXICITY.
CHRONIC TOXICITY:
DRUG ARE GIVEN FOR 6-12 MONTHS AND EFFECTS ARE STUDIED AS
SUBACUTE TOXICITY.
THIS IS UNDERTAKEN CONCURRENTLY WITH EARLY CLINICAL TRIAL.
52. SPECIAL LONG TERM TOXICITY:
THIS TEST ARE DONE FOR THE DRUG WHICH CROSS PHASE I
CLINICAL TRIAL.
REPRODUCTION AND TERATOGENECITY:
EFFECTS ON SPERMATOGENESIS, OVULATION, FERTILITY, AND
DEVELOPING FOETUS.
MUTAGENICITY:
ABILITY OF DRUG TO REDUCE GENERIC DAMAGE IS ASSED IN
BACTERIA (AMES TEST), MAMMILIAN CELL CULTURE AND INTACT
RODENT.
CARCINOGENECITY:
DRUG IS GIVEN FOR LONG TERM, EVEN WHOLE LIFE OF ANIMAL
AND THEY ARE WATCHED FOR TUMOURS.
STADERDISE PROCEDURE UNDER “GOOD CLINICAL PRACTICE”
(GLP) HAVE BEEN LAID DOWN.
53. DOCUMENTATION
ALL DATA ARE COLLECTED FROM PRECLINICAL
STUDY AND SENT IT TO REGULATORY AUTHORITY FOR
THE PERMISSION FOR FURTHER STUDY.
DATA ARE RECORDED IN ELECTRONIC AND WRITTEN
FORMAT.