Subacute toxicity study
These slides will be helpful for M.Pharm 2nd semester Pharmacology students to prepare for the subject " Toxicological Screening Methods" as per PCI new syllabus regulations
Assignment on Toxicokinetics- Toxicokinetic evaluation in preclinical studies, saturation kinetics Importance and applications of toxicokinetic studies. Alternative methods to animal toxicity testing.
This presentation will help understanding the vast process of rat and mice handling and oral routes of drug administration through acute class method (OECD: 423).
OECD Test Guideline 420: Acute Oral Toxicity - Fixed Dosepp_shivgunde
OECD Test Guideline 420: Acute Oral Toxicity - Fixed Dose
Guideline 420 was adopted in July 1992 as the first alternative to the conventional acute toxicity test.
This presentation provides a knowledge about Toxicology, its types , definition, regulatory guidelines for conducting toxicological studies, OECD guidelines for GLP. This is an assignment in the subject, Pharmacological & Toxicological Screening Methods - II, 2nd Semester, M.Pharm (Pharmacology)
Dermal Irritation and Dermal Toxicity Studies Dinesh Gangoda
Dermal irritation and Corrosion test guidelines 204.
Dermal irritation is the production of reversible damage of the skin following the application of a test chemical for up to 4 hours.
Corrosive reactions are typified by ulcers, bleeding, bloody scabs, and, by the end of observation at 14 days, by discolouration due to blanching of the skin, complete areas of alopecia, and scars. Histopathology should be considered to evaluate questionable lesions. [1]
Dermal corrosion is the production of irreversible damage of the skin; namely, visible necrosis through the epidermis and into the dermis, following the application of a test chemical for up to four hours.[2]
REFERENCES
OECD/OCDE, Test No. 404: ‘‘Acute Dermal Irritation/Corrosion’’, 28 July 2015 OECD Publishing, peris, Page no, 1- 8.
Robert A., Turner., Screening Methods in Pharmacology; 1st edition; Academic press an imprint of Elsevier, pp, 279- 281.
OECD Guideline for testing of chemicals (1981). ‘‘Repeated Dose Dermal Toxicity’’, 21/28- day Study.
Regulatory guidelines for conducting toxicity studies by ichAnimatedWorld
ICH is the “International Conference on Harmonization of
Technical Requirements for Registration of Pharmaceuticals for
Human Use”
ICH is a joint initiative involving both regulators and research based industry representatives of the EU, Japan and the US in
scientific and technical discussions of the testing procedures required
to assess and ensure the safety, quality and efficacy of medicines
REPRODUCTIVE TOXICITY STUDIES, Definition
Introduction, OECD guidelines for reproductive toxicity studies
Principle of the test, Description of Method, Procedure, Experimental Schedule, Data and Reporting, Results, Male Fertility Toxicological Studies
Ms. I. Sai Reddemma.
Department of Pharmacology
Dear Friends,
This is my 3rd presentation, which will help you to understand the depth knowledge of acute eye irritation/corrosion (OECD-405) study in rabbit.
Assignment on Toxicokinetics- Toxicokinetic evaluation in preclinical studies, saturation kinetics Importance and applications of toxicokinetic studies. Alternative methods to animal toxicity testing.
This presentation will help understanding the vast process of rat and mice handling and oral routes of drug administration through acute class method (OECD: 423).
OECD Test Guideline 420: Acute Oral Toxicity - Fixed Dosepp_shivgunde
OECD Test Guideline 420: Acute Oral Toxicity - Fixed Dose
Guideline 420 was adopted in July 1992 as the first alternative to the conventional acute toxicity test.
This presentation provides a knowledge about Toxicology, its types , definition, regulatory guidelines for conducting toxicological studies, OECD guidelines for GLP. This is an assignment in the subject, Pharmacological & Toxicological Screening Methods - II, 2nd Semester, M.Pharm (Pharmacology)
Dermal Irritation and Dermal Toxicity Studies Dinesh Gangoda
Dermal irritation and Corrosion test guidelines 204.
Dermal irritation is the production of reversible damage of the skin following the application of a test chemical for up to 4 hours.
Corrosive reactions are typified by ulcers, bleeding, bloody scabs, and, by the end of observation at 14 days, by discolouration due to blanching of the skin, complete areas of alopecia, and scars. Histopathology should be considered to evaluate questionable lesions. [1]
Dermal corrosion is the production of irreversible damage of the skin; namely, visible necrosis through the epidermis and into the dermis, following the application of a test chemical for up to four hours.[2]
REFERENCES
OECD/OCDE, Test No. 404: ‘‘Acute Dermal Irritation/Corrosion’’, 28 July 2015 OECD Publishing, peris, Page no, 1- 8.
Robert A., Turner., Screening Methods in Pharmacology; 1st edition; Academic press an imprint of Elsevier, pp, 279- 281.
OECD Guideline for testing of chemicals (1981). ‘‘Repeated Dose Dermal Toxicity’’, 21/28- day Study.
Regulatory guidelines for conducting toxicity studies by ichAnimatedWorld
ICH is the “International Conference on Harmonization of
Technical Requirements for Registration of Pharmaceuticals for
Human Use”
ICH is a joint initiative involving both regulators and research based industry representatives of the EU, Japan and the US in
scientific and technical discussions of the testing procedures required
to assess and ensure the safety, quality and efficacy of medicines
REPRODUCTIVE TOXICITY STUDIES, Definition
Introduction, OECD guidelines for reproductive toxicity studies
Principle of the test, Description of Method, Procedure, Experimental Schedule, Data and Reporting, Results, Male Fertility Toxicological Studies
Ms. I. Sai Reddemma.
Department of Pharmacology
Dear Friends,
This is my 3rd presentation, which will help you to understand the depth knowledge of acute eye irritation/corrosion (OECD-405) study in rabbit.
The guidelines describe about the subacute toxicity studies in rodents with a comparison with the previous guideline.it also includes the comparison of all three subacute toxicity studies OECD 407, OECD 410, and OECD 412
Field of pharmacology
Pharmacology practice school report .
Final year b pharmcy
Domain-Pharmacology
It include
1) experimental pharmacology
2) Toxicity study
3)pharmacovigilance
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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
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
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
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
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
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.
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The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
1. Repeated Dose Toxicity studies
(Subacute/Sub-chronic toxicity study)
Oral, Dermal and Inhalation routes
Dr. K. Nandakumar
Professor, Department of Pharmacology
MCOPS, MAHE, Manipal
2. Objectives of this Presentation
• The presentation will help the students of Master of Pharmacy (Pharmacology
and related disciplines) to comprehend the topic– ”Sub-acute toxicity studies” ,
in their curriculum. [PCI syllabus: Toxicological Screening Methods (MPL202T)].
• To describe how subacute toxicity studies are performed in industries, to meet
regulatory requirements.
• Describe OECD 407, 410 and 412 guidelines pertaining to repeated dose toxicities
of test chemicals administered via oral, dermal and inhalation routes.
3. Generally we adopt OECD guidelines
(1) The initial guidelines were published in 1981
(2) Revised in 1995 to include neuro and immunotoxicities.
(3) Ammended in 1998, to obtain information related to endocrine
disruptors
Oral route – Guideline no. 407 [28 d], 408 [90 d] (Rodents), 409 (Non-rodents)
Dermal route – Guidelines no. 410 [28 d], 411 [90 d],
Inhalation route – Guidelines no. 412 [28 d], 413 [90 d].
4. Principle of the Test
OECD 407 OECD 410 OECD 412
Test substance administered once
daily, by oral route, for 28 d.
Animals observed closely, each
day for signs of toxicity
Test substance administered dermally
for 28 days. Observed closely, each
day for signs of toxicity
Test substance - inhalation administered
for a defined period. Observed closely,
each day for signs of toxicity
Establish dose dependent relation-ship for the toxic effect
Allows to determination of the No-Observed Adverse Effect Level (NOAEL) and provide information on selection
of doses for long term studies
5. Selection and Preparation of Animals
OECD 407 OECD 410 ECD 412
Rats are the preferred species.
Lower species - increase variability: dissecting smaller organs.
Other species are accepted under suitable justification.
Young healthy adult animals of commonly used laboratory strains should be employed.
Females should be nulliparous and non pregnant.
The strain which has be adopted shall be in accordance to the chronic study.
Dosing should be initiated as early after the weaning period. At any case dosing should not be
delayed more than 9 weeks old.
Body weight variation should not exceed greater than 20%
6. Housing and Selection of doses
Husbandry conditions similar to Acute toxicity studies:
Temperature – 19 to 25o C, RH – 55%- 65% ; Light : dark- 12:12, Free
access to standard pellet and potable drinking water
Selection of doses: (Minimum 3 doses)
First High dose is decided
-
- This dose should induce
toxic effect but not severe
toxicity or death
- Toxicokinetic data, SAR,
Previous experience,
Efficacy study, LD10 may
help in predicting this
High DoseLow Dose Medium Dose
- Usually 2 to 4 times
reduced as compared to
the highest dose levels.
- Preferentially falls on the
human exposure dose.
- Should not produce any
observed toxic effect
- May be 10 times lower
than the medium dose
levels or higher dose
levels
7. Grouping and number of animals
25 males + 25 Females
Control
(5 M+ 5F)
Low dose
(5 M+5F)
Medium dose
(5M+5F)
High dose
(5M + 5F)
Satellite receives
high dose
(5M+5F)
5 groups
Additional animals can be kept in each group if interim sacrifices are planned. Exposure to various routes
is as per acute toxicity exposure.
Satellite groups helps to identify delayed type of toxicity and withdrawal effects. Limit dose studies can be
done at 1000 mg/kg
8. Mode of exposure of Test substance
OECD 407
Oral route
OECD 410
Dermal route
OECD 412
Inhalation route
Test substance - orally
administered for a defined period.
Observed closely, each day for
signs of toxicity
Test substance - skin administered
for a defined period. Observed
closely, each day for signs of toxicity
Test substance - inhalation administered
for a defined period. Observed closely,
each day for signs of toxicity
9. Observations
Daily observations:
Clinical observations, General health record of animals,
Mortality and morbidity
– Preferably at the same time on each day and at anticipated peak
period
Weekly observations:
- Body weight changes, Food and water intake
- Behavioral, neurological and autonomical profiles
End observations:
- Functional observations like grip strength, auditory, visual stimuli
etc.
- Vaginal smears, Blood collection, Gross necropsy and organ
collection
- Additional Blood sampling can be done to establish Toxicokinetics
and pharmacokinetics as per ICH guidelines
10. Parameters assessed
- Hematological parameters
- Clinical biochemistry
- Targeting to assess liver, kidney and heart functions
- Metabolic profiles and electrolyte balance
- Hormones and Endocrine related endpoints
- Wet weight of organs
- All the major weighable organs shall be weighed
- Expressed in terms of organ indices
- Gross necropsy and Histology of all the Organs.
- Satellite group will undergo the same procedure after 14 days of post
treatment. [28 +14 d]