Introduction to Absorbed Tatanus Vaccine
Principle, Assay methods of ATV, Preparation, Symptoms,
Causes, Risk factor, Complications
Presnted by
SHAIK GOUSE UL AZAM
Department of Pharmaceuticals Analysis
Assay of adsorbed diptheria vaccine and adsorbed tetanusRAGHAV DOGRA
diphtheria and tetanus vaccine, assay method, lethal dose method, Method A. challenge toxins in the guinea pig, Method B. challenge toxins in mice, Determination of antibodies in the guinea pig, guidelines .
Impurity profiling and degradent characterization {presented by shameer m.pha...ShameerAbid
these slides discuss
Impurity profiling
Degradation characterization
Stability testing & Accelerated stability testing (ICH)
Evaluation of the test (shelf life)
analytical method development
ICH vs USP definition
methods for identification
method for the isolation of the impurity
factors affecting the degradation of formulation
What is degradation characterization
general protocol of degradation conditions used for drug substance and drug product
Degradation conditions
Stress testing
Container closure system
Introduction to Absorbed Tatanus Vaccine
Principle, Assay methods of ATV, Preparation, Symptoms,
Causes, Risk factor, Complications
Presnted by
SHAIK GOUSE UL AZAM
Department of Pharmaceuticals Analysis
Assay of adsorbed diptheria vaccine and adsorbed tetanusRAGHAV DOGRA
diphtheria and tetanus vaccine, assay method, lethal dose method, Method A. challenge toxins in the guinea pig, Method B. challenge toxins in mice, Determination of antibodies in the guinea pig, guidelines .
Impurity profiling and degradent characterization {presented by shameer m.pha...ShameerAbid
these slides discuss
Impurity profiling
Degradation characterization
Stability testing & Accelerated stability testing (ICH)
Evaluation of the test (shelf life)
analytical method development
ICH vs USP definition
methods for identification
method for the isolation of the impurity
factors affecting the degradation of formulation
What is degradation characterization
general protocol of degradation conditions used for drug substance and drug product
Degradation conditions
Stress testing
Container closure system
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with basics impurity profiling and degradent characterization.
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
This document is intended to provide guidance for registration applications on the content and qualification of impurities in new drug substances produced by chemical syntheses and not previously registered in a region or member state.
In this slide contains definition and biological assay of Adsorbed Diphtheria Vaccine.
Presented by: G.CHIRANJEEVI (Department of pharmaceutical analysis).
RIPER, anantapur
2.6.12. microbiological examination of non sterile products (total viable aer...Guide_Consulting
Salah Satu Referensi Yang Digunakan Dalam One Day Seminar "Preservative Effectiveness Validation"
04 Desember 2014. Bogor
Detail : info@traininglaboratorium.com
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with basics impurity profiling and degradent characterization.
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
This document is intended to provide guidance for registration applications on the content and qualification of impurities in new drug substances produced by chemical syntheses and not previously registered in a region or member state.
In this slide contains definition and biological assay of Adsorbed Diphtheria Vaccine.
Presented by: G.CHIRANJEEVI (Department of pharmaceutical analysis).
RIPER, anantapur
2.6.12. microbiological examination of non sterile products (total viable aer...Guide_Consulting
Salah Satu Referensi Yang Digunakan Dalam One Day Seminar "Preservative Effectiveness Validation"
04 Desember 2014. Bogor
Detail : info@traininglaboratorium.com
Background: It is often difficult to predict which newborn with HIE will develop neurological sequlae so there is an urgent need for predictors for adverse neurological outcomes in these infants. Aim of Study: To evaluate the serum levels of serum amyloid A (SAA) protein in newborns with HIE during the first week of life and after 3 and 6 months of follow up to assess its correlation with degree of HIE neurological sequlee. Patients and Methods; This case-control study was conducted on 72 infants; group (1) included 36 full term neonates diagnosed as HIE and group (2)included 36 age and sex matched, infants as a control group, Serum amyloid A by ELIZA technique was measured at post natal age of 1 and 7 days, CT scan was done in justified cases .with follow up at age of 3 and 6 months for neurological sequlee. Results: SAA protein level was elevated in the asphyxiated group in comparison to the control group at day 1 and day 7, SAA level was significantly correlated to the Sarnat scoring system of HIE. SAA level significantly differ on follow up of developmental milestone at age of 3 and 6 months. ROC curve for validity of SAA for severity of HIE at cut off point > 25μg/ml at day 1 and at cut off point > 20 μg/ml at day 7 of HIE diagnosis reported sensitivity 100% and specificity 100% .Conclusion: SAA correlates with the severity of HIE and higher SAA expression is a prognostic marker for morbidity in these infants.
NOVEL IPQCL AND FPQC TEST FOR OPTHALMIC PREPARATION AS PER IP, BP A...roshan telrandhe
Ophthalmic preparation are the sterile liquid or semisolid preparation meant to installation in to the eyes in the space between eye lids and eye ball .
These product must be sterile and are prepare under the same condition as that of parenteral preparation
Pharmaceutical Biotechnology Research Presentation : Recombinant Streptokinase
Dr. Godfrey Mazhandu
Professor Peivand Pirouzi Inc. -
Copyright 2015 - Professor Peivand Pirouzi Inc., International Corporate Training, Canada
All rights reserved
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
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
- 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
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
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!
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.
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
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
1. HUMAN ANTIHAEMOPHILIC
VACCINE
SUBMITTED TO:
DR. C. SREEDHAR
PROFESSOR AND HOD
DEPT. OF PHARMACEUTICAL
ANALYSIS
KARNATAKA COLLEGE OF
PHARMACY
BANGALORE
SUBMITTED BY:
S.GOKULRAJ
M PHARM 1ST SEMESTER
DEPT.OF PHARMACEUTICAL
ANALYSIS
KARNATAKA COLLEGE OF
PHARMACY
BANGALORE
1 KARNATAKA COLLEGE OF PHARMACY
SUBJECT:APA
2. HUMAN ANTIHAEMOPHILIC
VACCINE
Introduction:
It is also called as human coagulation factor VIII.
This vaccine is used for treatment of haemophila
A.
It is rich in clotting factor VIII
Human Antihaemophilic vaccine which is
obtained from human plasma. It is rich in clotting
factor.
Antihemophilic factor is a naturally occurring
protein in the blood that helps blood to clot.
A lack of antihemophilic factor VIII is the cause
of hemophilia A.
2 KARNATAKA COLLEGE OF PHARMACY
3. Human antihemophilic factor works by temporarily
raising levels of factor VIII in the blood to aid in clotting.
Human antihemophilic factor is used to treat or prevent
bleeding episodes in people with hemophilia A. It is also
used to control bleeding related to surgery.
Category
Antihaemophilic to correct deficiencies of coagulation
factor Vlll
Description
White or pale yellow powder or friable solid.
Storage
Stored in atmosphere of nitrogen in light-resistant
containers at a temperature below 8°c. The containers
are sterile and sealed so as to exclude micro-organisms.
3 KARNATAKA COLLEGE OF PHARMACY
4. SELECTION OF HUMAN
DONORS
The plasma to be used for preparing Dried Human
Antihaemophilic vaccine
It is obtained from blood of healthy human donors
who are, as far as can be ascertained after clinical
examination, laboratory tests on their blood and
consideration of their medical history, free from
detectable agents of infection transmissible by
blood transfusion.
The examinations and tests to be carried out are
decided by the National Regulatory Authority.
4 KARNATAKA COLLEGE OF PHARMACY
5. In particular, the blood must be tested with negative
results for
(a) evidence of syphilis infection;
(b) hepatitis B surface antigen and
(c) HIV antibodies by suitably sensitive methods.
The haemoglobin value of the donor's blood is not less
than 12.5 per cent w/v.
5 KARNATAKA COLLEGE OF PHARMACY
6. PREPARATION OF HUMAN
ANTIHAEMOPHILIC VACCINE
The blood is withdrawn aseptically through a closed
system of sterile tubing into a sterile container in
which a suitable anticoagulant solution has been
placed before sterilization.
During the withdrawal there is no interruption in the
flow from the donor, and the container is gently
agitated.
Immediately after the withdrawal is completed, the
blood is cooled at 4°c
If the plasma is to be stored frozen it is separated
from the cellular components by centrifugation and
frozen to -300 or below, preferably within 12 hours
of collection.
If the plasma is not to be frozen it is separated from
the cellular components by centrifugation as soon
as possible and not later than 18 hours after
6 KARNATAKA COLLEGE OF PHARMACY
7. Dried Human Antihaemophilic Fraction may be
prepared :Ii-om human plasma so obtained by
precipitation under controlled conditions of pH, ionic
strength and temperature with organic solvents, or by
freezing and thawing.
The precipitate may be washed by extraction with
suitable solvents, dissolved in a solution of sodium
citrate adjusted to a pH of 6.8 to 7.2, which may also
contain sodium chloride.
The solution is sterilized by filtration through a
membrane filter, distributed in sterile containers and
dried from the frozen state.
The air is removed or replaced by oxygen-free
nitrogen and the containers are sealed so as to
7 KARNATAKA COLLEGE OF PHARMACY
8. IDENTIFICATION TESTS
PH
Loss on drying
Haemagglutinins, anti-A and anti-B.
Hepatitis B surface antigen
Abnormal toxicity
Pyrogens
Sterility
8 KARNATAKA COLLEGE OF PHARMACY
9. BIOLOGICAL ASSAY
Principle
The potency of antihaemophilic vaccine is determined
by comparing the amount necessary to reduce the
clotting time of a test mixture containing substances
that cause clotting of blood with the amount of the
Standard preparation necessary to produce the same
effect under the conditions of the following method of
assay.
9 KARNATAKA COLLEGE OF PHARMACY
10. Standard preparation
The Standard preparation is the 4th International
Standard for Blood coagulation factor
VIII:C,concentrate, human, established in 1989,
consisting of an intermediate purity concentrate of
human blood clotting factor VIII (supplied in ampoules
containing 6.3 Units of clotting factor VIII), or another
suitable preparation the potency of which has been
determined in relation to the International Standard
The Unit is the specific antihaemophilic factor
contained in such an amount of the Standard
preparation as the Ministry of Health & Family Welfare,
Govt. of India may from time to time indicate as the
quantity exactly equivalent to the Unit accepted for
international use
10 KARNATAKA COLLEGE OF PHARMACY
11. SPECIAL REAGENTS
Normal serum reagent
Phospholipid reagent
Clotting factor V solution
Substrate plasma
Substrate plasma deficient in clotting factor V
11 KARNATAKA COLLEGE OF PHARMACY
12. Preparation of the test and standard solution.
Add sufficient imidazole buffer pH 7.4 to produce solutions containing
betweens 0.5 and 2 units per ml (stable for 15 mins at 20c).
Three sucessive 2-fold dilutions in the range 1 in 16 to 1 in 256 using a
mixture of 1 volume of a 3.8%w/v solution of sodium citrate and 5 volumes
of saline solution as diluent.
(clotting times between 17 and 35 sec )
Introduce 0.1 ml each of clotting factor V solution, phospholipid reagent
and normal serum reagent into each of six glass incubation
tubes(75mm100mm).
To the first tube add 0.1 ml of the highest dilution of the standard
preparation place the tube in a water-bath at 37c, add 0.1 ml of 0.05M
calcium chloride and start stop-watch.
12 KARNATAKA COLLEGE OF PHARMACY
13. During the next minute add 0.1ml of the second highest dilution of the standard to a
second tube, place it in the water, and add 0.1 ml of 0.05M calcium chloride at
exactly 1 minute by the stopwatch.
Repeat the procedure with lowest dilution of the standard and highest to lowest
dilutions of the preparation being examined so that the calcium chloride solution is
added at 2, 3, 4 and 5 minutes by the stop-watch ,respectively
Place in a water bath at 37c twelve glass tubes each containing 0.2 ml of 0.025M
calcium chloride and a further tube containing about 3 ml of substrate plasma.
At 14 minutes, 40 seconds by the stop watch, transfer 0.1 ml of the mixture from the
first incubation tube to one of the tubes containing 0.2ml of 0.025M calcium
chloride solution and mix
13 KARNATAKA COLLEGE OF PHARMACY
14. At 15 minutes add 0.2 ml of the warmed substrate plasma and, using a second stop-
watch, record as the clotting time the time interval between the addition of the substrate
plasma and the first indication of fibrin formation which may be observed visually or by
mechanical means.
Repeat the procedure with the other incubation tubes at 1 minute interval and carry out a
second series of determinations at 21 to 26 minutes.
The period of incubation should, if necessary, be adjusted so that the clotting times
recorded in the corresponding tests in the two series of determinations do not differ by
more than 5%, showing that a stable plateau of prothrombin activator formation has been
reached.
Carry out a blank determination using in place of the preparation being examined.
An equal quantity of a mixture of 1 volume of a 3.8% w/v solution of sodium citrate and
5 volumes of saline solution.
The result of the Assay is not valid unless the clotting time in the blank determination is
more than 40 seconds .Calculate the result of the assay by standard statistical methods.
14 KARNATAKA COLLEGE OF PHARMACY
15. Side effect
Tingly feeling in your face, ears, or arms
Headache
blurred vision
Fever
Drowsiness
Runny nose
Skin rash
Joint pain 2 weeks later
Nausea
vomiting
Upper stomach pain, loss of appetite, dark
urine, clay-colored stools, jaundice (yellowing
of the skin or eyes).
15 KARNATAKA COLLEGE OF PHARMACY
16. uses
Used for treatment of haemophilia A.
It is used for deficiency of clotting factor.
Antihemophilic factor injection is used to treat
and control serious bleeding problem.
It is used for surgery time.
16 KARNATAKA COLLEGE OF PHARMACY