This document discusses various topics related to drugs including drug discovery, development and testing, controversial and banned drugs, drug abuse and its effects, and drug trafficking. It provides details on the drug development process and lists some controversial and banned drugs in India such as nimesulide, phenylpropanolamine, and ayurvedic medicines containing heavy metals. The document also outlines illegal drugs and their effects as well as issues related to drug trafficking.
This slide contains what is generic drug, what is advantages & disadvantages,reason behind unpopularity of generic drug in India, why generic drugs are important in India, why there is a need of generic drug policy, who are the regulatory authority, what are the act & laws, what policy existing in India for generic drug then Conclusion.
This slide contains what is generic drug, what is advantages & disadvantages,reason behind unpopularity of generic drug in India, why generic drugs are important in India, why there is a need of generic drug policy, who are the regulatory authority, what are the act & laws, what policy existing in India for generic drug then Conclusion.
Requirements And Guidelines For Permission To Import / or Manufacture of New Drugs For Sale or To Undertake Clinical Trials
Schedule Y was introduced under the Drugs and Cosmetics Act 1940, to
introduce requirements for countries to get permission for:
Importing
Manufacturing new drugs
Conducting Clinical Trials.
Application for permission
Clinical Trial
Studies in specific population
Post marketing surveillance
Special studies: BA/BE studies
Preclinical Development, Introduction
Definition, Stages of development of a new drug, Objectives of Preclinical studies, Several steps in preclinical trials, Types of studies in Preclinical trials, Importance of preclinical trials
By
Ms. I. Sai Reddemma.
Department of Pharmacology
Vaccine safety monitoring is a critical aspect of pharmacovigilance, particularly given the widespread use of vaccines to prevent infectious diseases. Robust surveillance systems are essential to detect and assess any potential adverse events following vaccination. Here are some key pharmacovigilance strategies employed for vaccine safety monitoring:
Passive Surveillance Systems:
Passive surveillance systems rely on healthcare providers, patients, and other stakeholders to voluntarily report adverse events following vaccination. These reports are collected in databases such as the Vaccine Adverse Event Reporting System (VAERS) in the United States or the Vaccine Adverse Event Surveillance System (VAESS) in other countries. While these systems are valuable for signal detection, they may suffer from underreporting and reporting bias.
Active Surveillance Systems:
Active surveillance involves proactively monitoring a defined population for adverse events following vaccination. This can be done through electronic health records (EHRs), claims databases, and other health data sources. The Vaccine Safety Datalink (VSD) in the United States is an example of an active surveillance system that uses large databases to continuously monitor vaccine safety.
Enhanced Surveillance and Cohort Studies:
Enhanced surveillance involves more intensive monitoring of a specific population or group of interest. Cohort studies are prospective studies that follow a group of vaccinated individuals over time to assess vaccine safety. These studies provide more detailed and controlled data compared to passive or active surveillance.
Comparative Effectiveness Research:
Comparative effectiveness research compares the safety of different vaccines or vaccination schedules. By analyzing large datasets, researchers can evaluate the relative risks and benefits of vaccines and identify any safety concerns.
Signal Detection and Analysis:
Data mining and statistical techniques are used to identify potential safety signals from adverse event reports. Signals are further investigated through in-depth analysis to determine if there is a causal relationship between the vaccine and the adverse event.
Causality Assessment:
Similar to general pharmacovigilance, causality assessment methods (such as the Naranjo Algorithm, WHO-UMC System, and Bayesian methods) are used to evaluate the likelihood of a causal relationship between a vaccine and an adverse event.
Risk Communication and Public Awareness:
Effective communication strategies are crucial to ensure that healthcare providers and the public are informed about vaccine safety. This involves providing clear and accurate information about potential risks and benefits.
Pharmacovigilance is science of detection,
assessment, reporting and prevention of adverse
reactions to drug(s).
Major aims of pharmacovigilance are:
1. Early detection of hitherto unknown adverse
reactions and interactions
2. Detection of increases in frequency of (known)
adverse reactions
3. Identification of risk factors and possible
mechanisms underlying adverse reactions
4. Estimation of quantitative aspects of benefit/risk
analysis and dissemination of information needed to
improve drug prescribing and regulation.
If you are marketing your product in India you should comply these area of regulation.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
Requirements And Guidelines For Permission To Import / or Manufacture of New Drugs For Sale or To Undertake Clinical Trials
Schedule Y was introduced under the Drugs and Cosmetics Act 1940, to
introduce requirements for countries to get permission for:
Importing
Manufacturing new drugs
Conducting Clinical Trials.
Application for permission
Clinical Trial
Studies in specific population
Post marketing surveillance
Special studies: BA/BE studies
Preclinical Development, Introduction
Definition, Stages of development of a new drug, Objectives of Preclinical studies, Several steps in preclinical trials, Types of studies in Preclinical trials, Importance of preclinical trials
By
Ms. I. Sai Reddemma.
Department of Pharmacology
Vaccine safety monitoring is a critical aspect of pharmacovigilance, particularly given the widespread use of vaccines to prevent infectious diseases. Robust surveillance systems are essential to detect and assess any potential adverse events following vaccination. Here are some key pharmacovigilance strategies employed for vaccine safety monitoring:
Passive Surveillance Systems:
Passive surveillance systems rely on healthcare providers, patients, and other stakeholders to voluntarily report adverse events following vaccination. These reports are collected in databases such as the Vaccine Adverse Event Reporting System (VAERS) in the United States or the Vaccine Adverse Event Surveillance System (VAESS) in other countries. While these systems are valuable for signal detection, they may suffer from underreporting and reporting bias.
Active Surveillance Systems:
Active surveillance involves proactively monitoring a defined population for adverse events following vaccination. This can be done through electronic health records (EHRs), claims databases, and other health data sources. The Vaccine Safety Datalink (VSD) in the United States is an example of an active surveillance system that uses large databases to continuously monitor vaccine safety.
Enhanced Surveillance and Cohort Studies:
Enhanced surveillance involves more intensive monitoring of a specific population or group of interest. Cohort studies are prospective studies that follow a group of vaccinated individuals over time to assess vaccine safety. These studies provide more detailed and controlled data compared to passive or active surveillance.
Comparative Effectiveness Research:
Comparative effectiveness research compares the safety of different vaccines or vaccination schedules. By analyzing large datasets, researchers can evaluate the relative risks and benefits of vaccines and identify any safety concerns.
Signal Detection and Analysis:
Data mining and statistical techniques are used to identify potential safety signals from adverse event reports. Signals are further investigated through in-depth analysis to determine if there is a causal relationship between the vaccine and the adverse event.
Causality Assessment:
Similar to general pharmacovigilance, causality assessment methods (such as the Naranjo Algorithm, WHO-UMC System, and Bayesian methods) are used to evaluate the likelihood of a causal relationship between a vaccine and an adverse event.
Risk Communication and Public Awareness:
Effective communication strategies are crucial to ensure that healthcare providers and the public are informed about vaccine safety. This involves providing clear and accurate information about potential risks and benefits.
Pharmacovigilance is science of detection,
assessment, reporting and prevention of adverse
reactions to drug(s).
Major aims of pharmacovigilance are:
1. Early detection of hitherto unknown adverse
reactions and interactions
2. Detection of increases in frequency of (known)
adverse reactions
3. Identification of risk factors and possible
mechanisms underlying adverse reactions
4. Estimation of quantitative aspects of benefit/risk
analysis and dissemination of information needed to
improve drug prescribing and regulation.
If you are marketing your product in India you should comply these area of regulation.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
The ban, which comes into effect immediately, follows recommendations of an expert committee formed to examine the efficacy of these drug combinations. The industry, though, may question the basis of the ban and seek judicial intervention.
Fixed drug combinations have mushroomed in the market as companies in their quest for newer products — and often to beat price control — mix and match ingredients into a single molecule to market them as newer remedies.
This training course on Drug Safety and Pharmacovigilance designed to give pharmaceutical and biologic companies operating in the U.S. and EU an understanding of product safety and regulatory compliance.
Importance of epidemics in mono and poly cyclic diseases caused by various plant pathogens and the mathematical models for studying the strategy of those epidemics
this ppt deals with different types of drug interactions with examples and highlights important principles in monitoring drug therapy....for better understanding of complexity of multiple drug usage (polypharmacy)
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.
A presentation describing pain, analgesia, formation of prostaglandins along with a detailed description of NSAIDS, the mechanism of action, classification and an in depth discussion of each class along with key points to be kept in mind for dentists
Introduction to Pharmacology of Anti-depressants
Classification, Ideal characteristics, Mechanism of action, Pharmacokinetic profile, Indications, Adverse effects, Drug interactions, Contra indications, Current trends, Conclusion
Presented by
G. Sai Swetha
Department of Pharmacology
This presentation consisits about antimanic agents, its mode of action, indication, contraindication, side-effects and nursing management. It also has details of Carbamazepine and Valporate.
Indian Dental Academy: will be one of the most relevant and exciting training center with best faculty and flexible training programs for dental professionals who wish to advance in their dental practice,Offers certified courses in Dental implants,Orthodontics,Endodontics,Cosmetic Dentistry, Prosthetic Dentistry, Periodontics and General Dentistry.
Oral mucosa reflects the health of the whole human body at a first glance.If any disorder is present in the system it will first appear in oral cavity. Here is an overview of certain pigmented lesions.
This presentation will give you a detailed knowledge about the various techniques that can be performed for imaging various aspects and diseases of TM Joint.
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
Honest Reviews of Tim Han LMA Course Program.pptxtimhan337
Personal development courses are widely available today, with each one promising life-changing outcomes. Tim Han’s Life Mastery Achievers (LMA) Course has drawn a lot of interest. In addition to offering my frank assessment of Success Insider’s LMA Course, this piece examines the course’s effects via a variety of Tim Han LMA course reviews and Success Insider comments.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
10. NIMESULIDE
• Non steroidal anti inflammatory drug
• Analgesic & antipyretic properties
• Not used in US, Finland, Spain, Bangladesh,
Portugal, Singapore and Israel –
STILL USED IN INDIA
• Trade names: Nise, Nodard plus, Nimulid, nimed
etc