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.
1.Patients have poor or no knowledge of the price variations among branded and generic medicines, and leave the choice of the medicine to the doctor.
2.The government must take up generic promotional schemes, general awareness programs on quality of generics to build confidence among prescribers, pharmacists, and consumers.
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.
1.Patients have poor or no knowledge of the price variations among branded and generic medicines, and leave the choice of the medicine to the doctor.
2.The government must take up generic promotional schemes, general awareness programs on quality of generics to build confidence among prescribers, pharmacists, and consumers.
This presentation is all about generic medicines.How it works in India its benefits and how one can make people aware about by the usage of these instead of branded ones.
PHARMACIST ROLE IN COMMUNITY PHARMACY , OTC GUIDELINES , PRESCRIPTION PRECAU...VENKATA RAMA RAO NALLANI
IT has covered choice medicine by cost ,taste, safety, Prescription precautions, COMMUNITY PHARMACY AND CLINICAL PHARMACIST RESPONSIBILITIES IN IN PATIENT CARE
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.
This presentation is all about generic medicines.How it works in India its benefits and how one can make people aware about by the usage of these instead of branded ones.
PHARMACIST ROLE IN COMMUNITY PHARMACY , OTC GUIDELINES , PRESCRIPTION PRECAU...VENKATA RAMA RAO NALLANI
IT has covered choice medicine by cost ,taste, safety, Prescription precautions, COMMUNITY PHARMACY AND CLINICAL PHARMACIST RESPONSIBILITIES IN IN PATIENT CARE
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.
Drug development life cycle indepth overview.pptxMohammadAbuzar19
The presentation is all about the insightfull short and crisp description of drug development life cycle including the drug discovery,clinical trial phases, branded,generic drugs,biologis,biosimilers,acts, patent and exclusivity of drug product.
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.
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!
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
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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
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
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
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.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
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.
2. CONTENTS
Introduction.
Legislative history.
When generic drug marketed.
Approval requirement for generic drug
Bioequivalence
Clinical research for generic drugs
ANDA
Life cycle of generic drug.
Indian generic drug market.
FDA regulation for generic drug
Conclusion
References
2
3. INTRODUCTION
A generic drug is defined as "a drug product that is comparable
to brand/innovator drug in dosage form, strength, route of
administration, quality and performance characteristics, and
intended use.“ It should contain the same active ingredients
as the original formulation.
According to the FDA, generic drugs are identical or within an
acceptable bioequivalent range to the brand-name
counterpart with respect to pharmacokinetic and
pharmacodynamics properties.
3
4. LEGISLATIVE HISTORY
• 1906 Pure Food and Drug Act –establishes regulation of food
and drugs.
• 1938 Food, Drug and Cosmetic Act – introduced safety
standards.
• 1962 Kefauver-Harris Amendments to the FDA&C Act – tightened
safety standards and introduced requirements that drug must be
effective i.e., proof of efficacy.
• 1984 Hatch- Waxman Act - created an abbreviated mechanism
for approval of generic copies of all drugs originally approved
after 1962, by stating that pre-clinical and clinical testing does not
have to be repeated for generics.
4
5. WHEN GENERIC DRUG MARKETED
After patent and exclusivity protection
ends
Patent owner waives its rights
FDA requirements are met
5
6. B R A N D N A M E D R U G
N D A R E Q U I R E M E N T
1. Labeling
2. Pharma
3. Chemistry
4. Manufacturing
5. Controls
6. Microbiology
7. Testing
8. Animal studies
9. Clinical studies
10. Bioavailability
G E N E R I C D R U G
A N D A R E Q U I R E M E N T
1. Labeling
2. Pharma
3. Chemistry
4. Manufacturing
5. Control
6. Microbiology
7. Testing
8. Bioequivalence
6
7. A generic drug is considered
to be bioequivalent to the
brand name drug if :
• The rate and extent of
absorption do not show a
significant difference
from the innovator drug ,
or
• The extent of absorption
does not show a
significant difference and
any difference in rate in
intentional or not
medically significant .
7
BIOEQUIVALENCE
8. CLINICAL RESEARCH FOR GENERIC DRUGS
• to demonstrate that the generic medicine is comparable to the
reference medicine so that it can receive a marketing
authorisation.
• to show that the generic medicine produces the same levels
of the active substance in the body as the reference
medicine.
• Bioequivalence studies to assure the therapeutic
equivalence.
• If a generic medicine contains a different salt of the active
substance to the salt used in the reference medicine
• If the medicine is a hybrid, additional tests may be required,
such as the results of clinical trials that test the efficacy of the
medicine.
8
9. BE STUDY DESIGN
• Bioequivalence trials are designed to compare the release, absorption,
and elimination of the active ingredient from two formulations of a
product (i.e., the unmarketed generic and corresponding brand-name
product) and, if successful, demonstrate similarity between both within
pre-established, statistically defined, pharmacokinetic parameters.
• Appropriate study protocol including the required number of subjects
and sampling intervals should be determined according to preliminary
studies and previously reported data.
• Design
– Randomized crossover studies
– Parallel designs can be employed..
9
11. ANDA
• An Abbreviated New Drug Application (ANDA) contains data which when
submitted to FDA's Centre for Drug Evaluation and Research, Office of
Generic Drugs, provides for the review and ultimate approval of a
generic drug product.
• Generic applicants must scientifically demonstrate that their product is
bioequivalent.
• Scientists demonstrate bioequivalence is to measure the time it takes
the generic drug to reach the bloodstream in 24 to 36 healthy
volunteers. This gives them the rate of absorption, or bioavailability, of
the generic drug, which they can then compare to that of the innovator
drug.
• The generic version must deliver the same amount of active ingredients
into a patient's bloodstream in the same amount of time as the innovator
drug.
11
15. INDIAN GENERIC DRUG MARKET
• U S C E N S U S B U R E A U H E A L T H & N U T R I T I O N ( 2 0 0 5 -
2 0 1 0 )
• In 2010 India’s share of the
generic market is about 30%
out of 71.2% and reached
$100 billion.
• In late 2012 40% of DMF’s
were filled by Indian market
in USFDA for supplying
API’s.
• Now India’s share of the
generic market is about to
35%. Hence the contribution
of the Indian pharmaceutical
industry for the growth of
generic drugs in the world is
very high.
15
16. RECENT RULES BY FDA FOR GENERIC DRUG
FOR INDIA
Generic drug manufacturers would be able to independently update product labelling (also
called prescribing information or package inserts) with newly-acquired safety
information before the FDA’s review of the change, in the same way brand drug
manufacturers do today. Generic manufacturers would also be required to inform the
brand name manufacturer about the change.
All generic drug makers, including Ranbaxy Laboratories, Cipla, Dr Reddy's Laboratories
and Lupin, are now required to pay a fee to the US drug regulator while seeking
permission to launch their products in the world's largest drug market.
The recently enacted Generic Drug User Fee Act (GDUFA) legislation adds a $20,000-
$30,000 fee at the first time the DMF is referenced in an ANDA. However, the current
rates are in effect only till September 30, 2013, and will be revised every year and is
likely to affect the number of DMFs filed in the coming years from India and around
the world.
16
17. CONCLUSION
After the expiry of patent or marketing rights of
the patent drug, generic drugs are marketed.
They are comparable to brand drug in dosage
form, strength, route of administration, quality
and performance characteristics, and intended
use. Generic drugs are available at affordable
prices with maintaining quality. These ‘Generic’
formulations balance public interest as critical
disease like cancer, AIDS etc. India’s
Pharmaceutical market will grew at 9.5% by
2015.
17