PMS are the studies done after the drug is marketed to ensure the safety and efficacy of drugs. Here detailed about the need for PMS, sources of informations and methods of PMS
Abbreviated New Drug Application (ANDA).pptxdipakkendre2
An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Format of ANDA, Contents of ANDA, generic drug approval process, generic Drugs, ANDA certification clauses
PMS are the studies done after the drug is marketed to ensure the safety and efficacy of drugs. Here detailed about the need for PMS, sources of informations and methods of PMS
Abbreviated New Drug Application (ANDA).pptxdipakkendre2
An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Format of ANDA, Contents of ANDA, generic drug approval process, generic Drugs, ANDA certification clauses
For better understanding of students. This will give you a detailed explanation of IND APPLICATION. Contact me through comment section if you need any assistance in understating this topic.
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
Regulatory Affairs is a profession which has developed from the desire of governments to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
Approval and Application Process involved in Investigational New Drug (IND)Nipun Gupta
1. Introduction
During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies.
2. Drug development team
3. Investigational new drug application (INDA)
4. Format and content of IND
5. Preclinical testing
6. The development process IND
application and safety
7. Clinical research
8. New drug application
9. Abbreviated new drug application
10. Changes to an approved NDA or ANDA
11. Difference between NDA and ANDA
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
Post Marketing Surveillance (Regulatory affairs).pptxYuvaraj KG
Postmarketing drug surveillance refers to the monitoring of drugs once they reach the market after clinical trials. It evaluates drugs taken by individuals under a wide range of circumstances over an extended period of time.
For better understanding of students. This will give you a detailed explanation of IND APPLICATION. Contact me through comment section if you need any assistance in understating this topic.
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
Regulatory Affairs is a profession which has developed from the desire of governments to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
Approval and Application Process involved in Investigational New Drug (IND)Nipun Gupta
1. Introduction
During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies.
2. Drug development team
3. Investigational new drug application (INDA)
4. Format and content of IND
5. Preclinical testing
6. The development process IND
application and safety
7. Clinical research
8. New drug application
9. Abbreviated new drug application
10. Changes to an approved NDA or ANDA
11. Difference between NDA and ANDA
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
Post Marketing Surveillance (Regulatory affairs).pptxYuvaraj KG
Postmarketing drug surveillance refers to the monitoring of drugs once they reach the market after clinical trials. It evaluates drugs taken by individuals under a wide range of circumstances over an extended period of time.
Pharmacovigilance is defined as, The pharmacological science and activities concerned with the detection, assessment, understanding and prevention of adverse reactions to medicines or Pharmacovigilance is the name given to the mechanisms and controls that together map and ensure the safety of a medicine throughout its life span – from test tube to patient.
The pharma aspirants can read the important information provided in this presentation about Pharmacovigilance which is necessary to qualify the interviews of the same field
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Growing Prevalence of Lifestyle Diseases
The rising incidence of lifestyle diseases such as diabetes, cardiovascular diseases, and cancer is a major trend driving the clinical trials market in India. These conditions necessitate the development and testing of new treatment methods, creating a robust demand for clinical trials. The increasing burden of these diseases highlights the need for innovative therapies and underscores the importance of India as a key player in global clinical research.
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Health Education on prevention of hypertensionRadhika kulvi
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NDIS and Community 24/7 Nursing Care is a specific type of support that may be provided under the NDIS for individuals with complex medical needs who require ongoing nursing care in a community setting, such as their home or a supported accommodation facility.
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CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
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Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
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Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
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Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
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One of the most developed cities of India, the city of Chennai is the capital of Tamilnadu and many people from different parts of India come here to earn their bread and butter. Being a metropolitan, the city is filled with towering building and beaches but the sad part as with almost every Indian city
3. INTRODUCTION
Phases of clinical trial
• Microdosing study ( Phase 0) :Done in very small number of people. Investigators use a very
small dose of medication to make sure that it isn’t harmful to humans before they start
using higher doses for lateral phase.
1.PHASE 1: Healthy volunteers (20-100) Safety & dosage.
2.PHASE2 : People with disease condition (100-300) Efficacy
&side effects.
3.PHASE 3: People with disease condition (300-3000) Confirm
effectiveness and monitoring of adverse drug reaction .
4.PHASE 4(POST MARKETING
SURVEILLANCE ):Track adverse events and monitors
effects in real world.
4. • Postmarketing drug surveillance refers to the monitoring of drugs once they
reach the market after clinical trials.
• It evaluates drugs taken by individuals under a wide range of circumstances
over an extended period of time. Such surveillance is much more likely to
detect previously unrecognized positive or negative effects that may be
associated with a drug.
• The majority of postmarketing surveillance concern adverse drug reactions
(ADRs) monitoring and evaluation.
• Other important postmarketing surveillance components include
unapproved or off-label drug use, problems with orphan drugs, and lack of
paediatric formulations, as well as issues concerning international clinical
trials in paediatric population.
5. • The process of evaluating and improving the
safety of medicines used in paediatric
practice is referred to as paediatric
pharmacovigilance.
It requires special attention. Childhood
diseases and disorders may be qualitatively
and quantitatively different from their adult
equivalents.
6. HISTORY
• Thalidomide was a widely used drug in the late 1950s and early 1960s for
the treatment of nausea in pregnant women.
• In 1961 in Germany ,an astute pediatrition (Lenz) expressed concern about
the sudden large increase in the number of children referred to his clinic
with limb deformitis (Phocomelia) and thalidomide tragedy has been
identified .
• The prevention of unwanted drug effects became matter of worldwide public
concern.
7. • Edward Kennedy (senator) suggested that a better system was needed for
monitoring the use and effects of prescription drugs after they were
marketed.
• As a result, the Joint Commission on Prescription Drug Use was established
in 1976, funded largely by the drug industry, with the mandate to design a
postmarketing surveillance
8. Importance of PMS
• Post market surveillance not only meets regulatory requirements while
monitoring the safety of consumers, but also ensures continuous
consumer acceptance of the products and financial viability.
• Post-market surveillance is a passive, multifactorial, performance-
process for health professionals, manufacturers, regulators and the
monitor the performance during the lifecycle of a product in the open
market.
• It is important for manufacturers and regulators to share common
safety surveillance keeping consumers in mind.
9. Goal of PMS
• The goal of surveillance system is to identify the product use patterns or
conditions responsible for adverse effects and characterize relative incidence
rates compared to market penetration, units sold or other denominator-
generating benchmarking data.
• To determine the frequency of adverse reactions or safety attributable to a
product, spontaneous reports, information on utilization and extent of
consumption is essential.
• Compare a new products or treatments with existing options and the standard of
care .
• Update clinical guidelines as certain populations or groups find more benefit than
others .
10. Benefits of PMS
• Real world evidence delivered through PMS .
• Post-market surveillance can provide additional information on the natural
history of disease and the relative performance of their product to the
disease, as well as other marketed products.
• Post-market surveillance can provide information on how products perform
others in the context of real-world patient populations, which are often
from clinical trial populations. This can then inform treatment decisions,
use of products
• Post-market surveillance can shed light on which products and drugs are
most cost-effective.
11. Types & source of real world data
A.Clinical data : 1)Electronic health records.2)Case report forms.
B. Patient generated data :1) Health & treatment history. 2)Patient reported
outcomes .
C. Cost & utilization data :Claims datasets .
D.Public health data: Government data source
12. Post Market Surveillance System
Evaluate
Report
Collect
Proative data Reactive data
PLAN
PMS PMCF
13. ACTION
• CAPA
Corrective Action :The action was taken to
rectify ,fix or correct a specific deviation ,defect or
undesirable situation .
Preventive Action :The action was taken to
eliminate the cause of deviation ,defect in order
to prevent the future occurrence of such an event
.
• UPDATE:The dosage strength or composition
of dosage form.
14. Process of PMS
Data Collection
• Collect real-
world
data efficiently,
securely, and
accurately for
post-market
surveillance
activities.
Data Analysis
• Use advanced
data science to
transform RWD
to RWE
Data Interpretation
• Once collection
& analysis is
finished,then
interpret the
data easily &
readily.
• To ensure timely
and accurate
interpretation of
data, you need
statistically-
adjusted reports
that are
available in real-
time.
15. Methods of PMS
• The essence of the various methods of postmarketing surveillance of drugs
is the ability to make observations about drug effects in an environment
where the drugs are being used in a customary therapeutic or diagnostic
situation.
• In order to accomplish this, the investigation of marketed drugs requires the
application of observational rather than experimental methods.
• The ability of a particular surveillance method to detect a drug’s effect
depends on two factors.
1) )The time that transpires between use of that drug and the occurrence of
the drug’s effect (the latency period).
2) How often the effect occurs (its frequency).
17. Voluntary Reporting
• Voluntary reporting by physicians and other health care providers, hospitals,
and consumers may act to alert FDA and pharmaceutical firms to possible
adverse effects of drugs.
• These surveillance systems enable physicians and pharmacists to report suspected
ADRs and thus act as a tool to identify new ADRs and risk factors predisposing to
recognized ADRs.
• It is acknowledged that only a small proportion of ADRs are actually reported to
national reporting centres and pharmaceutical companies. Insight into reasons for
underreporting should enable national reporting centres to take appropriate
measures to increase reporting rates.
18. Control clinical trials
• Controlled clinical trials are used primarily for evaluating drug efficacy, not
safety, because they are carried out on hundreds, or, at the most, a few thousand
drug users.
• Their use for evaluating drugs already on the market is also limited by their high
cost and logistical problems.
• These limitations of controlled clinical trials in evaluating the safety of marketed
drugs have led to relying on cohort and case-control methods for postmarketing
studies.
19. Cohort study
• Cohort design is a type of nonexperimental or observational study design.
Cohort studies are important in research design.
• The term “cohort” is derived from the Latin word “Cohors” – “a group of
soldiers.”
• In a cohort study, the participants do not have the outcome of interest to begin
with. They are selected based on the exposure status of the individual. Thus,
some of the participants may have the exposure and others do not have the
exposure at the time of initiation of the study.
• They are then followed over time to evaluate for the occurrence of the
outcome of interest.
20. Prospective
Prospective means looking forward
(into the future)
It is a type of cohort study where the
researchers enrol participants into the study
before they develop the disease.
Involves a group of people who don’t have
the disease under study.
Retrospective
Retrospective means looking
backwards (into the past)
It is a cohort study that analyzes two group of
people those with disease under study as well as a
very similar group of people who do not have the
disease.
Involves a group of people who already
have the disease under study
22. Case control study
• Case-control studies are retrospective.
• They clearly define two groups at the start: one with the disease and
disease.
• They look back to assess whether there is a statistically significant
rates of exposure to a defined risk factor between the groups.
23. Advantages
• Cheaper
• Quicker
• Good for diseases with long latency periods
Disadvantages
• Retrospective / more prone to bias.
• Can only assess one Disease.