The document discusses generic drug product development. It defines a generic drug as having the same active ingredients, dosage form, strength, quality, and intended use as the branded version. Generic drugs are available after patent expiration or waiver. The generic product development process involves concept development, system-level design, detail design, testing and refinement, and production ramp-up to launch the product.
An innovator or branded drug is the first drugs created containing its specific active ingredient to receive approval for use.
A generic drug is made of the same active ingredient as its innovator drug.
Regulatory Requirements For New Drug Approval.
This topic is from Industrial Pharmacy-II, B.Pharm Final year VIIth semester.
It include rule and regulations related to new drug approval for clinical use.
The presentation is about: Drug Regulatory Affairs as a profession, Scope & Responsibilities in life cycle management of a drug and role of RA in the drug approval process.
International Journal of Drug Regulatory Affairs; 2014, 2(1), 1- 11
Abstract:
Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This article focuses on drug approval process in different countries like USA, Europe and India.
An innovator or branded drug is the first drugs created containing its specific active ingredient to receive approval for use.
A generic drug is made of the same active ingredient as its innovator drug.
Regulatory Requirements For New Drug Approval.
This topic is from Industrial Pharmacy-II, B.Pharm Final year VIIth semester.
It include rule and regulations related to new drug approval for clinical use.
The presentation is about: Drug Regulatory Affairs as a profession, Scope & Responsibilities in life cycle management of a drug and role of RA in the drug approval process.
International Journal of Drug Regulatory Affairs; 2014, 2(1), 1- 11
Abstract:
Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This article focuses on drug approval process in different countries like USA, Europe and India.
Industrial design
It is the creative act of determining and defining a product's form and features, which takes place in advance of the manufacture or production of the product.
This presentation on the industrial products, formulation and the equipment of industry. We reserch on the need of industrial design and development.
Cook medical incorporated product pipeline analysisraja1233
Companyprofilesandconferences.com glad to promote a new report on "Cook Medical Incorporated - Product Pipeline Analysis" which is a source for data, analysis, and actionable intelligence on the company’s portfolio of pipeline products also provides key information about the company, its major products and brands.
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
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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.
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.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of 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 leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
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. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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.
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.
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
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
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journey
Generic drug development
1. GENERIC DRUGS PRODUCT DEVELOPMENT
By
Souvik Chattopadhyay
M.Pharm, 1st Year
Department of Pharmaceutics,
Himalayan pharmacy institute
2. GENERIC DRUG
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
3. WHAT ARE GENERIC DRUGS ?
They are drugs which have the same chemical composition as
branded drugs are and sold under their chemical name . For
example paracetamol , a pain killer , is the generic name for
branded drugs like Crocin and Calpol.
The market situation is a little different in India than the USA or
other developed nations . In USA , when a new drug is launched only
the company that holds the FDA patent are legally allowed to set
the drug , thus giving them market monopoly.
In India however there were no patent laws till 2005 which meant
that anyone could replicate any drug in India without legal
ramifications . This led to the trend of branded generic drugs which
has 99.5% of the country’s generic drug share
4. WHEN GENERIC DRUG MARKETED
A patent and exclusivity after
protection ends
Patent owner waives its rights
FDA requirements are met
5.
6. WHERE ARE THEY AVAILABLE?
Generic drugs are sold everywhere including our local
chemist.To buy them one simply has to ask for generic
version of a branded drug though they don’t have them for
all medicines
The department of pharmaceuticals of the government is
responsible for promoting generic drugs but they have not
done a very good job
After the expiry of the 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.
7. PRODUCT DEVELOPMENT
PRODUCT : A product is something sold
by an enterprise to its customers.
PRODUCT DEVELOPMENT : Product
development is the set of activities
beginning with the perception of a
market opportunity and ending in the
production , sale and delivery of a
product.
8. THE PRODUCT DEVELOPMENT PROCESS
A process is a sequences of steps that
transforms a set of inputs into a set of
outputs
A product development process is the
sequence of steps or activities that an
enterprise employs to conceive , design ,
and commercialize a product.
Some organizations define and follow a
precise and detailed product development
process . While others may not even be
able to describe their processes.
9. A GENERIC PRODUCT DEVELOPMENT PROCESS
We will consider here a generic product development
that can be used in a market pull- situation.
The input of the process is a mission statement and the
output of the process is the product launch
MISSION STATEMENT : identifies the target
market for the product , provides a basic functional
description of the product , and specifies the business
goals of the effort ; results from well executed product
planning phase
PRODUCT LAUNCH : Occurs when the product
becomes available for purchase in the market place
10.
11. CONCEPT DEVELOPMENT
The needs of the target market are identified
, alternative product concepts are generated
and evaluated , and a single development is
selected for further development
A concept is the description of the form ,
function and features of a product and is
usually accompanied by a set of specifications ,
an analysis of competitive products , and an
economic justification of the project
12. SYSTEM –LEVEL DESIGN
Includes the definition of the product architecture and the
division of the product into subsystems and components
The final assembly scheme for the production system is usually
defined during this phase
The output of this phase is usually a geometric layout of the
product , a functional specification of each of the products
subsystems , and a preliminary process flow diagram for the
final assembly process
13. DETAIL DESIGN
Includes the complete specification of the
geometry , materials , and tolerance of all the
unique parts in the product and the
identification of all the standard parts to be
purchased from suppliers.
A process plan is established and tooling is
designed for each part to be fabricated within
the production system
The output of this phase is the control
documentation for the product.
14. TESTING AND REFINEMENT
Involves the construction and evaluation of multiple pre – production
versions of the product.
Early prototypes are usually built with production intent parts [parts with
the same geometry and material properties as intended for the production
version of the product will work as designed and whether or not the
product will work as designed and whether or not the product satisfies the
key customer needs
Later prototypes are usually built with parts supplied by the intended
production process but may not be assembled using the intended final
assembly process
Later prototypes are extensively evaluated internally and are also
typically tested by customers in their own use environment
The goal of the beta prototypes is usually to answer questions about
performance and reliability in order to identify necessary changes for the
final product.
15. PRODUCTION RAMP –UP
Ramp up is a term used in economics and business to
describe an increase in firm production ahead of
anticipated increases in product demand.
Alternatively, ramp up describes the period from
completed initial product development to maximum
capacity utilization, characterized by product and
process experimentation and improvements.
Ramp up in the first sense often occurs when a
company strikes a deal with a distributor, retailer, or
producer, which will substantially increase product
demand.