This document discusses FDA's expedited drug development programs, including Fast Track designation. It provides details on the criteria for Fast Track designation, such as intended use for a serious or life-threatening condition with unmet medical need. The process for requesting and receiving Fast Track designation is also outlined, including submitting to the IND and providing supporting information demonstrating the drug meets the criteria. Key FDA expedited programs like Fast Track, Breakthrough Therapy, Accelerated Approval and Priority Review are intended to facilitate development and review of new drugs for serious conditions.
Lets, just get to know more about safety reporting in clinical trails with some terminologies, reporting requirements of ADR, compensations involved and finally the role of ethics committee in it,
Lets, just get to know more about safety reporting in clinical trails with some terminologies, reporting requirements of ADR, compensations involved and finally the role of ethics committee in it,
Regulation in clinical trial, Schedule Y and recent amendmentsDr. Siddhartha Dutta
Regulatory framework of India, Acts and Regulations for conduct of clinical trial in India, Schedule Y, approval of new chemical entity and recent amendments
Spontenous adr reporting in india
PASSIVE survillence system, data assement
data aciqsition, data interpretation, what all information required in ADR form, WHEN TO REPORT
BLUE CARD,YELLOW CARD, WHO CODES
Fast track Designation is a designation for accelerated approval of drugs and medicines in US. Presentation contains brief view of this expedite program.
PHARMACOVIGILANCE
The World Health Organization (WHO) defines Pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”
ADVERSE DRUG REACTION
According to WHO “ADR is a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.”
Introduction to MedDRA Coding in Drug Safety & Pharmacovigilance Process for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Investigator: A person responsible for the conduct of the study at the trial site.
Investigator is a person responsible for the rights, health and welfare of the study subjects.
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.
PHARMACOVIGILANCE TERMINOLOGIES ASKED IN INTERVIEWS-
For more information regarding PHARMACOVIGILANCE, CLINICAL RESEARCH, CLINICAL DATA MANAGEMENT & DRUG REGULATORY AFFAIRS kindly contact us on 9028839789
Regulation in clinical trial, Schedule Y and recent amendmentsDr. Siddhartha Dutta
Regulatory framework of India, Acts and Regulations for conduct of clinical trial in India, Schedule Y, approval of new chemical entity and recent amendments
Spontenous adr reporting in india
PASSIVE survillence system, data assement
data aciqsition, data interpretation, what all information required in ADR form, WHEN TO REPORT
BLUE CARD,YELLOW CARD, WHO CODES
Fast track Designation is a designation for accelerated approval of drugs and medicines in US. Presentation contains brief view of this expedite program.
PHARMACOVIGILANCE
The World Health Organization (WHO) defines Pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”
ADVERSE DRUG REACTION
According to WHO “ADR is a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.”
Introduction to MedDRA Coding in Drug Safety & Pharmacovigilance Process for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Investigator: A person responsible for the conduct of the study at the trial site.
Investigator is a person responsible for the rights, health and welfare of the study subjects.
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.
PHARMACOVIGILANCE TERMINOLOGIES ASKED IN INTERVIEWS-
For more information regarding PHARMACOVIGILANCE, CLINICAL RESEARCH, CLINICAL DATA MANAGEMENT & DRUG REGULATORY AFFAIRS kindly contact us on 9028839789
While the world is going through pandemic turmoil and regulatory agencies are under immense stress to approve newer pharmaceutical therapies to market. However, the classical/regular clinical trial is a hefty process hence alternative provisions like speed trials were explored for the early entry of drugs for emergency usage.
Controlled Substance Prescribing: What to Do?RIAPA
Dr. James MacDonald, Chief Administrative Officer or the RI Board of Medical Licensure and Discipline presents to the RIAPA on controlled substance prescribing in RI.
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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
- 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
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These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
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
Title: Sense of Smell
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 primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
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
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
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
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.
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.
2. Contents to be discussed
What is a fast track process.
What is Serious and Life threatening condition.
Types of drugs intended to treat Serious conditions.
Unmet medical needs.
Types of drugs intended to treat Unmet medical needs.
Process for designation of a drug to a Fast Track drug.
3. The types of Expedited studies under FDA program are:
1. FAST TRACK DESIGNATION
2. BREAKTHROUGH THERAPY DESIGNATION
3. ACCLERATED APPROVAL
4. PRIORITY REVIEW DESIGNATION
• The above 4 FDA programs are intended to facilitate and
expedite development and review of new drugs to address unmet
medical need in the treatment of a serious or life-threatening
condition.
• The purpose of this guidance for industry is to provide a single
resource for information on FDA’s policies and procedures for
these four programs as well as threshold criteria generally
applicable to concluding that a drug is a candidate for these
expedited development and review programs.
4. Fast Track Drug Development is a process that is designed
to facilitate the development, and expedite the review of
drugs to treat serious conditions and fill an unmet medical
need.
• The purpose fast track drugs is to get important new drugs
to the patient earlier.
• The drugs that are approved through the Fast Track Drug
Development process are called are fast track drugs.
5. • The Fast track expedited study comes under the FD&C act
Section506.
Section506 contains 3 subsections-
Section 506(a),
Section 506(b),
Section 506(c).
6. •Section 506(a) provides that sponsors may request fast track
designation concurrently with the IND filing or any time
thereafter.
•Section 506(b) includes various standards for approvals,
limitations and conditions with the addition of the clinical
endpoints.
•Section 506(c) provides submission and review of NDA for
fast track designation.
In this guidance FDA discusses the regulations, policies and
procedures related to facilitating the development and
expediting the review of promising therapies for serious and
life threatening conditions for which there is an unmet
medical need.
7. What is Serious and Life threatening condition.
• A disease or condition associated with morbidity that has
substantial impact on day-to-day functioning is called as a
serious or a life threatening conditions.
• Whether a disease or condition is serious is a matter of
clinical judgment, based on its impact on such factors as
survival, day-to-day functioning, or the likelihood that the
disease, if left untreated, will progress from a less severe
condition to a more serious one.
• Acquired Immunodeficiency syndrome(AIDS) and all other
stages of HIV (Human Immunodeficiency Virus), Alzheimer’s
disease, Cancer and many other diseases are “Serious”.
8. What kind of Drug are intended to Treat a
Serious Condition
• For a product to be in a fast track drug development
process, it must be intended to have a effect on a serious
condition or serious aspect of the condition.
• The products that can be designated for the Fast Track
drug development study are:
1. A product that is intended to treat a serious conditions
while avoiding the side effects of that treatment might be
designated for the fast track drug development study if
the side effects avoided are not serious.
9. 2. A diagnostic product intended to improve diagnosis or detection
of a serious condition in a way that would lead to improved
outcomes.
3. A product intended to prevent a serious treatment-related side
effect (e.g., serious infections in patients receiving
immunosuppressive therapy).
4. A product intended to avoid or diminish a serious adverse event
associated with available therapy for a serious condition (e.g.,
product that is less cardiotoxic than available cancer therapy)
5. A product intended to prevent a serious condition or reduce the
likelihood that the condition will progress to a more serious
condition or a more advanced stage of disease .
In all the above conditions the treatments or the products may be
designated to be as a fast track drug development process.
10. Demonstrating the potential to Address the unmet
medical needs
• The section 506(a) apart from requesting for a Fast Track designation,
further requires that the drug demonstrates the potential to address
the unmet medical needs.
Unmet Medical Needs
• An unmet medical need is a condition whose treatment or diagnosis is
not addressed adequately by available therapy.
Now there are 2 consequences:
1. If there is no available therapy for a serious condition, there is clearly
an unmet medical need.
2. When available therapy exists for a condition.
11. A new treatment generally would be considered to address an
unmet medical need if the treatment:
• Has an improved effect on a serious outcome(s) of the condition
compared with available therapy.
• Has an effect on a serious outcome of the condition that is not
known to be influenced by available therapy .
• Has an effect on a serious outcome of the condition in patients
who are unable to tolerate or failed to respond to available
therapy.
• Can be used effectively with other critical agents that cannot be
combined with available therapy
• Provides safety and efficacy comparable to those of available
therapy but has a documented benefit, such as improved
compliance, that is expected to lead to an improvement in serious
outcomes.
12. • In some cases, a drug that is not shown to provide a direct
efficacy or safety advantage over available therapy may
provide an advantage that would be of sufficient public
health benefit to qualify as meeting an unmet medical need.
• For example, in a condition for which there are approved
therapies that have a modest response rate, a drug with a
novel mechanism of action (but comparable safety and
effectiveness) could have the potential to provide an
advantage over available therapy in some patients. In such a
case, the novel mechanism of action should have a well-understood
relationship to the disease pathophysiology.
• In addition, there should be a reasonable basis for
concluding that a significant number of patients may
respond differently to the new drug compared with available
therapy.
13. Process for Designation of a drug as a product in a
Fast Track Development Program.
Section 506(b) of the FD&C Act provides for the designation of a drug
as a fast track product “ if it is intended, whether alone or in
combination with one or more other drugs, for the treatment of a
serious or life-threatening disease or condition, and it demonstrates
the potential to address unmet medical needs for such a disease or
condition.”
The designation process includes several steps, they are:
1.When to Send a Designation Submission
2.Where to Send a Designation Submission
3.Content of a Designation Submission
4.FDA Response
14. 1. When to Send a Designation Submission
• Sponsors may request Fast Track designation when the IND
is first submitted or at any time thereafter before
receiving marketing approval of their BLA or NDA.
• The IND and potential fast track designation may be
discussed before an IND submission in a pre-IND meeting,
but a decision on designation would await submission of the
IND.
• If a sponsor’s drug development program is granted fast
track designation for one indication and has subsequently
obtained data to support fast track designation for another
indication, the sponsor should submit a separate request.
15. 2. Where to Send a Designation Submission
The IND or amendment should be sent to the IND
administrative file to the attention of the appropriate review
division or office in CDER or CBER.
16. 3. Content of a Designation Submission
Fast track designation requests should contain the following
information:
• If the fast track designation request is submitted to the
sponsor’s IND as an amendment, identification of the
submission in the cover letter as a REQUEST FOR FAST
TRACK DESIGNATION in bold, uppercase letters.
• If the request is submitted with an initial IND,
identification of the submission in the cover letter as
both an INITIAL INVESTIGATIONAL NEW DRUG
SUBMISSION and REQUEST FOR FAST TRACK
DESIGNATION in bold, uppercase letters.
17. • In the cover letter of the submission, the name of the sponsor’s
contact person and the contact person’s address, email address,
telephone number, and fax number.
• If applicable, the IND application number.
• If available, for drug products, the proprietary name and active
ingredient and for biological products, the proper name and
proprietary name.
• The division or office to which the IND is being submitted or in
which it is active.
• The proposed indication(s).
• A concise summary of information that supports the fast track
designation request for the indication being studied, i.e. the
drug is intended to meet a serious or life threatening conditions.
And drug has the potential to meet the unmet medical conditions
18. 4. FDA Response
• FDA will respond to fast track designation requests within 60 calendar
days of receipt of the request.
a. Designation letter
the Agency determines that the criteria for designation as a fast track
drug development program have been met, the designation letter will:
• State that Fast Track Designation is granted for development of the
product for use in treating the specific serious condition.
• Point out that the sponsor should design and perform studies that can
show whether the product meets an unmet medical need.
• Alert the sponsor to the need for the drug development program to
continue to meet the criteria for fast track designation
19. b. Nondesignation letter
• If the Agency determines that a fast track
designation request was incomplete or that the
drug development program failed to meet the
criteria for fast track designation, the Agency will
send a nondesignation letter to the sponsor.
• The nondesignation letter will state that fast
track designation is not granted and explain the
reasons for the Agency's decision
20. References:
• www.fda.gov./Guidance for Industry Expedited Programs
for Serious Conditions.in
• The Pharmaceutical Regulatory Process by Ira . R . Berry.