Making medicines safer - Express Pharma
The document discusses reasons how life saving medicines can turn dangerous or fatal. It lists lack of adequate quality control during manufacturing, improper transportation and storage conditions, inadequate prescription practices, and lack of post-marketing surveillance as key factors. Unless corrective measures are taken to address these issues by all agencies involved, there is a risk that medicines intended to treat or prevent diseases may instead cause serious health problems or death.
Drug Safety & Pharmacovigilance - Introduction - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
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 Safety & Pharmacovigilance - Introduction - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
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
Legal requirements for generics and abridged products and bioequivalenceinemet
PharmaCon2007 Congress, Dubrovnik, Croatia "New Technologies and Trends in Pharmacy, Pharmaceutical Industry and Education" http://www.pharmacon2007.com
Abstract is available at http://www.pharmaconnectme.com
Fixed dose combination products – rationality, status in india, development i...Dr Sukanta sen
The development of FDCs is becoming increasingly
important from a public health perspective.
•They are being used in the treatment of a wide range of
conditions and are particularly useful in the management of
human immunodeficiency virus/acquired immunodeficiency
syndrome (HIV/AIDS), malaria and tuberculosis, which are
considered to be the foremost infectious disease threats in the world today.
Following file comprises of information about interactions taking place between herbs-drug, herbs-herbs, it also highlights some of the cases of clinical laboratory test interactions taking place due to use of herbal medicines.
Bruno Flamion, Professor of Physiology and Pharmacology, Molecular Physiology Research Unit, University of Namur
Presentation at EIPG – VAPI-UPIP Symposium “Biotech and Advanced Therapies: Challenges and Opportunities” at the Faculty of Medicine and Pharmacy, Campus Jette, Vrije Universiteit van Brussel, Brussels 2013
pharmacovigilance, adverse effects, causality assessment,methods, who-umc method with case study, FOR DOWNLOAD PPT MAIL ME ON iamgauravchhabra@gmail.com
HERE I INCLUDED HISTORY, RESPONSIBILITIES, TERMINOLOGY AND METHODS INVOLVED .
HOPE IT WILL BE USEFUL FOR YOU TO UNDERSTAND THE BASICS OF PHARMACOVIGILANCE.
This ppt is about pharmacovigilance in India & spontaneous reporting of adverse drug effect and there regulation by WHO or uppsala. It also include drug interaction in herbal medicine.
Legal requirements for generics and abridged products and bioequivalenceinemet
PharmaCon2007 Congress, Dubrovnik, Croatia "New Technologies and Trends in Pharmacy, Pharmaceutical Industry and Education" http://www.pharmacon2007.com
Abstract is available at http://www.pharmaconnectme.com
Fixed dose combination products – rationality, status in india, development i...Dr Sukanta sen
The development of FDCs is becoming increasingly
important from a public health perspective.
•They are being used in the treatment of a wide range of
conditions and are particularly useful in the management of
human immunodeficiency virus/acquired immunodeficiency
syndrome (HIV/AIDS), malaria and tuberculosis, which are
considered to be the foremost infectious disease threats in the world today.
Following file comprises of information about interactions taking place between herbs-drug, herbs-herbs, it also highlights some of the cases of clinical laboratory test interactions taking place due to use of herbal medicines.
Bruno Flamion, Professor of Physiology and Pharmacology, Molecular Physiology Research Unit, University of Namur
Presentation at EIPG – VAPI-UPIP Symposium “Biotech and Advanced Therapies: Challenges and Opportunities” at the Faculty of Medicine and Pharmacy, Campus Jette, Vrije Universiteit van Brussel, Brussels 2013
pharmacovigilance, adverse effects, causality assessment,methods, who-umc method with case study, FOR DOWNLOAD PPT MAIL ME ON iamgauravchhabra@gmail.com
HERE I INCLUDED HISTORY, RESPONSIBILITIES, TERMINOLOGY AND METHODS INVOLVED .
HOPE IT WILL BE USEFUL FOR YOU TO UNDERSTAND THE BASICS OF PHARMACOVIGILANCE.
This ppt is about pharmacovigilance in India & spontaneous reporting of adverse drug effect and there regulation by WHO or uppsala. It also include drug interaction in herbal medicine.
Sai Pharma Solutions Inc. has has been instrumental in providing services on consultation and turnkey project basis in Regulatory Affairs, Quality Management and GMP compliance since 2008. We offer consultation and undertake turnkey projects in development and implementation of Quality Systems which incorporates Regulatory Affairs, Quality and cGMP documentation, DMF and Dossier Management, SOP Management, Technical and Scientific Advice management, Validation and Qualification Management, Gap Analysis, Review, Assessment, Audits and Training. Our clientele includes the upcoming and existing pharmaceutical industries. We are known for the best"QQS" worldwide. The quality of our work speaks volumes about our efforts and endeavours".
Gave a talk at StartCon about the future of Growth. I touch on viral marketing / referral marketing, fake news and social media, and marketplaces. Finally, the slides go through future technology platforms and how things might evolve there.
Each technological age has been marked by a shift in how the industrial platform enables companies to rethink their business processes and create wealth. In the talk I argue that we are limiting our view of what this next industrial/digital age can offer because of how we read, measure and through that perceive the world (how we cherry pick data). Companies are locked in metrics and quantitative measures, data that can fit into a spreadsheet. And by that they see the digital transformation merely as an efficiency tool to the fossil fuel age. But we need to stretch further…
The Six Highest Performing B2B Blog Post FormatsBarry Feldman
If your B2B blogging goals include earning social media shares and backlinks to boost your search rankings, this infographic lists the size best approaches.
The Value of Conducting Post-Marketing Clinical Research On Marketing Strategy Development
Nutraceutical Medical Research, LLC
By: Latesha Richards, Marketing Coordinator
Pharmacovigilance is a scientific discipline concerned with the collection, detection, assessment, monitoring, and prevention of adverse effects of pharmaceutical products.
Pharmacovigilance is a branch of Pharmacoepidemiology and is restricted to the study of adverse effects of drugs.
The safe use of medicines is perhaps the single most important criteria that any regulatory authority within a given country has to ensure in order both to protect the public health and the integrity of its health care system. For the same purpose pharmacovigilance was established. According to WHO, Pharmacovigilance is the science and activities related to the collection, detection, and assessment of ADR’s. It promotes the systematic, rational use and assures the confidence for the safety of drugs. It improves patient care and safety. Significance of pharmacovigilance is growing as the patients or consumers have become more responsive about the advantage and hazard of medicines. Pharmacovigilance is a complex process and a robust system is essential to undertake the activity. A good pharmacovigilance system will identify the hazard aspects in the short period of time. This review article tries to explain the some basic principles, history and developments, methods and some scope of this developing field i.e. Pharmacovigilance in India.
Role of Human Resource Department in the Management of Drug Safety in Pharmac...ImtiajChowdhuryEham
Role of Human Resource Department in the Management of Drug Safety in Pharmaceutical Industry..
Imtiaj Hossain Chowdhury
B’Pharm (Jahangirnagar University), M’Pharm (Jahangirnagar University)
Master’s in Public Health (American International University Bangladesh)
Post Marketing Surveillance and Pharmacoepidemiologyijtsrd
Post Marketing Surveillance PMS and pharmacoepidemiology are essential components of drug safety monitoring and effectiveness evaluation in real world clinical settings. PMS involves the continuous monitoring of pharmaceutical products after regulatory approval to detect and assess adverse events and safety issues that may not have surfaced during pre marketing clinical trials. Pharmacoepidemiology, on the other hand, employs epidemiological methods to study the effects of drugs in large populations, utilizing real world data from various sources. This article explores the significance of PMS and pharmacoepidemiology in ensuring patient safety, highlights their mutual contributions in research, and underscores the importance of collaborative efforts between regulatory agencies, academia, and pharmaceutical companies. The challenges related to data quality, privacy, and ethical considerations are discussed, along with potential advancements in methodologies and the integration of new technologies for future research and vigilance in drug safety and public health. Dr. Farheen Yousuf "Post-Marketing Surveillance and Pharmacoepidemiology" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-4, August 2023, URL: https://www.ijtsrd.com/papers/ijtsrd59690.pdf Paper Url:https://www.ijtsrd.com/pharmacy/other/59690/postmarketing-surveillance-and-pharmacoepidemiology/dr-farheen-yousuf
Vastu is the exact science but some people have connected it with the orthodox practices to misguide the people.Vastu is based on the following principles of science:
1. Principle of energy flow
2. Principle of open space
3. Principle of shapes
4. Principle of angles
5. Principle of directions
6. Principle of gravity(Mass)
7. Principle of height
8. Principle of slope
9. Principle of placement of rooms
10.Principle of elements
9.
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- 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
- 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
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the 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 lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
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. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Best Ayurvedic medicine for Gas and IndigestionSwastikAyurveda
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
CDSCO and Phamacovigilance {Regulatory body in India}NEHA GUPTA
The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. Operating under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, the CDSCO is responsible for approving new drugs, conducting clinical trials, setting standards for drugs, controlling the quality of imported drugs, and coordinating the activities of State Drug Control Organizations by providing expert advice.
Pharmacovigilance, on the other hand, is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. The primary aim of pharmacovigilance is to ensure the safety and efficacy of medicines, thereby protecting public health.
In India, pharmacovigilance activities are monitored by the Pharmacovigilance Programme of India (PvPI), which works closely with CDSCO to collect, analyze, and act upon data regarding adverse drug reactions (ADRs). Together, they play a critical role in ensuring that the benefits of drugs outweigh their risks, maintaining high standards of patient safety, and promoting the rational use of medicines.
1. Making medicines safer - Express Pharma
www.expresspharmaonline.com FORTNIGHTLY INSIGHT FOR PHARMA PROFESSIONALS 1 - 15 July 2011
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Making medicines safer
Pharma Life
Pharma Ally J Ramnivas, Chief Executive Officer, Sai Pharma Solutions, lists
the many reasons how life saving medicines can turn out to be
Specials
just the opposite
Express Biotech
Every day we read the news of tragic deaths after
Services receiving vaccines. These incidents are putting
question mark on the safety of medicines. Rational
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usage of medicines is the need of the hour. If the
Open Forum corrective and preventive measures are not taken in
Subscribe/Renew time, the people will refuse to vaccinate their
Archives children and which in turn can lead to breakouts of diseases that
Search would have been easily preventable. Instead of shifting blame,
Media Kit there is need for introspection otherwise there is a great risk
lurking right from manufacturing to prescription and ultimately
Contact Us
usage by patients.
Network Sites
The official reason for the deaths as per government records is
Express Computer
adverse events following immunisation. But it is difficult to
Express Channel Business
believe how they have arrived at these conclusions. Deaths after
Express Hospitality vaccination could be a reaction to the components of vaccine.
Express TravelWorld Either it could be due to preservatives or the content. The other
Express Healthcare reason may be standard procedures laid down for the usage of
Group Sites these vaccines are violated. If vaccine vials are not used within
stipulated time hours of opening, they can get contaminated and
ExpressIndia
vaccination of such contaminated medicines can lead to serious Pharma
Indian Express tragic incidents. Formulation
Financial Express
METTLER
Before launching the medicine in the market it has to pass
TOLEDO
through preclinical studies followed by clinical studies. The
formulation
manufacturer has to file IND prior to initiation of clinical trials
software
and toxicological studies of the medicine are undertaken. On mt.com/pharmaceutic…
being found safe with least toxicological concerns, clinical studies
can begin only when preclinical studies have been successfully
completed and an approval has been received from the drug Jobs in
regulating authority for the conduct of clinical trials. During Pharma
clinical trial studies where safety and efficacy of medicines is Vacancies in top
determined. The clinical trials for the medicine is started in companies.
different phases which cover treatment trials, prevention trials, Submit Your
diagnostic trials, screening trials and quality of life trials Resume Free.
(supportive care trials).The purpose of conducting clinical trials in Now!
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purity and quality of medicines to mitigate the risks. During
clinical trials if anything goes wrong and is not investigated, the Clinical
medicine which is supposed to be life saving can turn out to be Research
the medicine of death. Courses
Clinical Research
Lack of adequate post marketing surveillance is one of the root Courses from Top
http://www.expresspharmaonline.com/20110715/management02.shtml[7/8/2011 4:32:26 PM]
2. Making medicines safer - Express Pharma
causes of such eventualities. This is a matter of great concern. Universities. Apply
Once the medicine gets the nod of drug regulatory authorities Now & Get Info!
for marketing approval. This is very important phase because it StudyPlaces.com/Clini…
often garners additional data about the safety and efficacy of
medicines where it has been marketed for patient use. At this Drug
stage, if there is no co-ordination between medical practitioners Interaction
and drug regulatory authorities, there will be no reporting of Center
adverse drug reactions and no corrective and preventive action Learn about
will be taken. At this stage, the involved agencies and drug commonly
regulation enforcing authorities should understand their misunderstood
respective responsibilities. Efforts should be made to make the food-drug
system more effective and foolproof. But unfortunately post interactions.
marketing surveillance is lacking in our country and outcome www.druginteractionc…
thereof is observed when we come across the news of tragic
eventualities in the news papers, TV etc.
There are several reasons for the contamination of medicines
leading to deaths. If these following factors are ignored, life
saving medicine can become medicine of death:
1. Lack of adequate quality systems during manufacturing
of medicines: During the manufacturing, testing, packing
labeling and storage of medicines if there no adequate quality
systems in place and GMP regulations are violated, there are
possibilities for the medicine to get contaminated and can pose
health hazards.
2. Lack of adequate transportation: Shipping of medicines
plays very important role. If during transportation, the required
storage conditions are not maintained, this can lead to the
degradation of the medicines and impurity formation. The toxic
nature of impurities can also trigger health hazards to the
patients and can result in any eventuality.
3. Lack of proper storage conditions: The situation of
pharmacy stores is very pathetic. Hardly there is any pharmacy
store meeting pharmacopoeial storage conditions. Yet they have
approval from the drug regulating agencies. This is matter of
great concern. Within the pharmacy store medicines become
poison if their required storage conditions are not met. In
addition to the storage issues, there is lack of control for the
expired date medicines. The ignorance of drug regulating
authorities and lack of awareness in patients is causing a
threatening situation which needs to be addressed on priority
basis.
4. Lack of adequate prescription: In India, quacks prescribe
medicines which need to be prescribed by qualified medical
professionals. The reason is the redily available treatment at
cheaper cost from quacks. These quacks do not know the right
usage of medicines and ultimately prescription by such quacks
can become a bone of contention for health issues and instead of
remedy, this practice jeopardises the health of patients. In some
cases pharmacists play the role of doctors and deliver schedule
H medicines as the over the counter (OTC) medicines.
Irrational use of medicines is a global problem and particularly
more common in developing countries like India because of
under surveillance from the regulatory agencies and less
awareness among medical professionals and public in general. It
is widely assumed that use of drug by a qualified doctor is
http://www.expresspharmaonline.com/20110715/management02.shtml[7/8/2011 4:32:26 PM]