The Indian pharmaceutical regulatory bodies have introduced major changes to guidelines on GMP, GCP, and GLP to align with international standards and ensure quality drugs. The revised GMP guidelines emphasize cleaning validation and prevent cross-contamination. The current GCP guidelines are aligned with ICH, opening opportunities for international clinical trials in India. The industry will face challenges complying with the new guidelines but it will help establish global quality standards and positioning India as a leader in pharmaceuticals.
Indian regulatory requirements - industrial pharmacy 2Jafarali Masi
Indian Regulatory Requirements: Central Drug Standard Control Organization (CDSCO) and State Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for New Drugs
A phase 1 clinical trial includes the initial introduction of an investigational new drug product, including biological drug products, into humans. Such studies are conducted to establish the basic safety of the drug, and are designed to determine the metabolism and pharmacologic actions of the drug in humans. The total number of subjects in a phase 1 clinical trial is limited generally to no more than 80 subjects.
This presentation covers the CGMP’s for Investigation New Drugs for Phase I. The presentation has been compiled from publicly available material on the world wide web by “ Drug Regulations” a not for profit organization.
Indian regulatory requirements - industrial pharmacy 2Jafarali Masi
Indian Regulatory Requirements: Central Drug Standard Control Organization (CDSCO) and State Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for New Drugs
A phase 1 clinical trial includes the initial introduction of an investigational new drug product, including biological drug products, into humans. Such studies are conducted to establish the basic safety of the drug, and are designed to determine the metabolism and pharmacologic actions of the drug in humans. The total number of subjects in a phase 1 clinical trial is limited generally to no more than 80 subjects.
This presentation covers the CGMP’s for Investigation New Drugs for Phase I. The presentation has been compiled from publicly available material on the world wide web by “ Drug Regulations” a not for profit organization.
NEW ERA OF DRUG PRODUCT: OPPORTUNITIES AND CHALLENGESganpat420
Abstract
Introduction
Global pharmaceutical industry
Indian pharmaceutical industry
Indian Pharmaceutical Market
Opportunities
Challenges
Conclusion
References
Good Manufacturing Practice (GMP) 2day course Jo Havemann
The following topics were presented to the participants through lectures, group discussions and exercises during 16 hours:
- Core values and guidelines of Good Laboratory Practice (GLP)
- Factors that might lead to questionable research & manufacturing practices and their impact
- GMP compliance, national & international regulations, guidelines and authorities
- Quality Management and Assessment
- Digital GMP Solutions
A Review on Quality by Design and its Approachesijtsrd
The Pharmaceutical Quality By Design QBD is a systematic approach to the development that starts with the predetermined objectives and is based on the process of understanding process processes and process control, sound science and quality risk management. Quality Design QBD has been created to increase the assured of providing safe, effective medicines to customers and promised to make significant improvements in product quality performance. Supriya Khatal | Ashok Bhosale | Tejaswini Kande | Pallavi Dhekale | Punam Bramhadandi | Pratima Pokale "A Review on Quality by Design and its Approaches" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-3 | Issue-6 , October 2019, URL: https://www.ijtsrd.com/papers/ijtsrd29248.pdf Paper URL: https://www.ijtsrd.com/pharmacy/medicinal-chemistry/29248/a-review-on-quality-by-design-and-its-approaches/supriya-khatal
A healthy manufacturing sector is very essential for the development of any economy. But talking about pharmaceutical manufacturing then it is not something which everyone and every economy can perform. Nepal as being naturally rich country it have some advantage and competitiveness in this industry if the capacities are utilized. due to which there are many foreign Ayurvedic companies which made their way to Nepal to have such herbs. A well developed pharmaceutical system promotes investment by the identified investors in the country leading to various business opportunities, mobilizing funds and effective utilization of resources.
NEW ERA OF DRUG PRODUCT: OPPORTUNITIES AND CHALLENGESganpat420
Abstract
Introduction
Global pharmaceutical industry
Indian pharmaceutical industry
Indian Pharmaceutical Market
Opportunities
Challenges
Conclusion
References
Good Manufacturing Practice (GMP) 2day course Jo Havemann
The following topics were presented to the participants through lectures, group discussions and exercises during 16 hours:
- Core values and guidelines of Good Laboratory Practice (GLP)
- Factors that might lead to questionable research & manufacturing practices and their impact
- GMP compliance, national & international regulations, guidelines and authorities
- Quality Management and Assessment
- Digital GMP Solutions
A Review on Quality by Design and its Approachesijtsrd
The Pharmaceutical Quality By Design QBD is a systematic approach to the development that starts with the predetermined objectives and is based on the process of understanding process processes and process control, sound science and quality risk management. Quality Design QBD has been created to increase the assured of providing safe, effective medicines to customers and promised to make significant improvements in product quality performance. Supriya Khatal | Ashok Bhosale | Tejaswini Kande | Pallavi Dhekale | Punam Bramhadandi | Pratima Pokale "A Review on Quality by Design and its Approaches" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-3 | Issue-6 , October 2019, URL: https://www.ijtsrd.com/papers/ijtsrd29248.pdf Paper URL: https://www.ijtsrd.com/pharmacy/medicinal-chemistry/29248/a-review-on-quality-by-design-and-its-approaches/supriya-khatal
A healthy manufacturing sector is very essential for the development of any economy. But talking about pharmaceutical manufacturing then it is not something which everyone and every economy can perform. Nepal as being naturally rich country it have some advantage and competitiveness in this industry if the capacities are utilized. due to which there are many foreign Ayurvedic companies which made their way to Nepal to have such herbs. A well developed pharmaceutical system promotes investment by the identified investors in the country leading to various business opportunities, mobilizing funds and effective utilization of resources.
SCHF 2012 - Fare SMM nel B2B: si può? L’esperienza SAP Italia Freedata Labs
Il caso SAP Italia al Social Case History Forum 2012: dalla definizione della strategia all'implementazione dei canali social media. In questa presentazione raccontiamo come anche il settore B2B può sviluppare un social media marketing di successo, a partire da una strategia di Web Listening, fino alla definizione degli obiettivi e delle azioni da mettere in campo.
Without George R.R. Martin, there is no game of thrones. However, on the track that we are on, it seems like the Song of Ice and Fire author might not finish the series. Here is why
The past year may have been too excited to take time off for a vacation, but we recommend you change that in 2017 at least. Even if you can't make much time for a long weekend option in India, holiday packages in India, So we got in touch with swantour.com in who gave us their tips on where to go and what to do, in India, swantour.com a leading travel agents in India and trusted travel company in India provides all domestics and international holiday packages at lowest price
Good Manufacturing Practice (GMP) | Arrelic InsightsArrelic
Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production, which may broadly be categorized in two groups: cross contamination/mix-ups and false labeling. Above all, manufacturers must not place patients at risk due to inadequate safety, quality or efficacy; for this reason, risk assessment has come to play an important role in WHO quality assurance guidelines.
Writekraft Research and Publications LLP was initially formed, informally, in 2006 by a group of scholars to help fellow students. Gradually, with several dissertations, thesis and assignments receiving acclaim and a good grade, Writekraft was officially founded in 2011 . Since its establishment, Writekraft Research & Publications LLP is Guiding and Mentoring PhD Scholars.
Our Mission
“To provide breakthrough research works to our clients through Perseverant efforts towards creativity and innovation”.
Vision
Writekraft endeavours to be the leading global research and publications company that will fulfil all research needs of our clients. We will achieve this vision through:
Analyzing every customer’s aims, objectives and purpose of research
Using advanced and latest tools and technique of research and analysis
Coordinating and including their own ideas and knowledge
Providing the desired inferences and results of the research
In the past decade, we have successfully assisted students from various universities in India and globally. We at Writekraft Research & Publications LLP head office in Kanpur, India are most trusted and professional Research, Writing, Guidance and Publication Service Provider for PhD. Our services meet all your PhD Admissions, Thesis Preparation and Research Paper Publication needs with highest regards for the quality you prefer.
Our Achievements
NATIONAL AWARD FOR BEST RESEARCH PROJECT (By Hon. President APJ Abdul Kalam)
GOLD MEDAL FOR RESEARCH ON DISABILITY (By Disabled’s Club of India)
NOMINATED FOR BEST MSME AWARDS 2017
5 STAR RATING ON GOOGLE
We have PhD experts from reputed institutions/ organizations like Indian Institute of Technology (IIT), Indian Institute of Management (IIM) and many more apex education institutions in India. Our works are tailored and drafted as per your requirements and are totally unique.
From past years our core advisory members, research team assisted research scholars from various universities from all corners of world.
Regulatory Affairs in the Pharmacy Curriulum A Reviewijtsrd
The Indian pharmaceutical industry is expanding quickly, and there is a need of regulatory affairs specialists to meet the present demands of companies in the face of international competition. The goal of governments to protect public health has led to the development of a relatively new profession known as regulatory affairs. Pharmaceuticals, veterinary medications, medical gadgets, pesticides, agrochemicals, and cosmetics are among the industries where the government regulates the safety and effectiveness of products. And alternative treatments. The pharmaceutical firms in charge of these drugs discovery, development, testing, clinical trials, production, manufacturing, and marketingItems also want to make sure that they are providing products that are secure and beneficial to the health and welfare of the general public. legislative issuesThe international regulatory bodies and the pharmaceutical businesses are connected via specialists. It is needed that they. Akshay Kaware | Prof. Santosh Waghmare | Dr. Hemant Kamble "Regulatory Affairs in the Pharmacy Curriulum: A Review" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-7 , December 2022, URL: https://www.ijtsrd.com/papers/ijtsrd52279.pdf Paper URL: https://www.ijtsrd.com/pharmacy/other/52279/regulatory-affairs-in-the-pharmacy-curriulum-a-review/akshay-kaware
Writekraft Research and Publications LLP was initially formed, informally, in 2006 by a group of scholars to help fellow students. Gradually, with several dissertations, thesis and assignments receiving acclaim and a good grade, Writekraft was officially founded in 2011 . Since its establishment, Writekraft Research & Publications LLP is Guiding and Mentoring PhD Scholars.
Our Mission
“To provide breakthrough research works to our clients through Perseverant efforts towards creativity and innovation”.
Vision
Writekraft endeavours to be the leading global research and publications company that will fulfil all research needs of our clients. We will achieve this vision through:
Analyzing every customer’s aims, objectives and purpose of research
Using advanced and latest tools and technique of research and analysis
Coordinating and including their own ideas and knowledge
Providing the desired inferences and results of the research
In the past decade, we have successfully assisted students from various universities in India and globally. We at Writekraft Research & Publications LLP head office in Kanpur, India are most trusted and professional Research, Writing, Guidance and Publication Service Provider for PhD. Our services meet all your PhD Admissions, Thesis Preparation and Research Paper Publication needs with highest regards for the quality you prefer.
Our Achievements
NATIONAL AWARD FOR BEST RESEARCH PROJECT (By Hon. President APJ Abdul Kalam)
GOLD MEDAL FOR RESEARCH ON DISABILITY (By Disabled’s Club of India)
NOMINATED FOR BEST MSME AWARDS 2017
5 STAR RATING ON GOOGLE
We have PhD experts from reputed institutions/ organizations like Indian Institute of Technology (IIT), Indian Institute of Management (IIM) and many more apex education institutions in India. Our works are tailored and drafted as per your requirements and are totally unique.
From past years our core advisory members, research team assisted research scholars from various universities from all corners of world
Subjects/Areas We Cover
Management, Commerce, Finance, Marketing, Psychology, Education, Sociology, Mass communications, English Literature, English Language, Law, History, Computer Science & Engineering, Electronics & Communication Engineering, Mechanical Engineering, Civil Engineering, Electrical Engineering, Pharmacy & Healthcare
Writekraft Research and Publications LLP was initially formed, informally, in 2006 by a group of scholars to help fellow students. Gradually, with several dissertations, thesis and assignments receiving acclaim and a good grade, Writekraft was officially founded in 2011 . Since its establishment, Writekraft Research & Publications LLP is Guiding and Mentoring PhD Scholars.
Our Mission
“To provide breakthrough research works to our clients through Perseverant efforts towards creativity and innovation”.
Vision
Writekraft endeavours to be the leading global research and publications company that will fulfil all research needs of our clients. We will achieve this vision through:
• Analyzing every customer’s aims, objectives and purpose of research
• Using advanced and latest tools and technique of research and analysis
• Coordinating and including their own ideas and knowledge
• Providing the desired inferences and results of the research
In the past decade, we have successfully assisted students from various universities in India and globally. We at Writekraft Research & Publications LLP head office in Kanpur, India are most trusted and professional Research, Writing, Guidance and Publication Service Provider for PhD. Our services meet all your PhD Admissions, Thesis Preparation and Research Paper Publication needs with highest regards for the quality you prefer.
Writekraft Research and Publications LLP was initially formed, informally, in 2006 by a group of scholars to help fellow students. Gradually, with several dissertations, thesis and assignments receiving acclaim and a good grade, Writekraft was officially founded in 2011 . Since its establishment, Writekraft Research & Publications LLP is Guiding and Mentoring PhD Scholars.
Writekraft Research & Publications LLP
(Regd. No. AAI-1261)
Mobile: 7753818181, 9838033084
Email: info@writekraft.com
Web: www.writekraft.com
Research Paper Writing
Writekraft Research and Publications LLP was initially formed, informally, in 2006 by a group of scholars to help fellow students. Gradually, with several dissertations, thesis and assignments receiving acclaim and a good grade, Writekraft was officially founded in 2011 . Since its establishment, Writekraft Research & Publications LLP is Guiding and Mentoring PhD Scholars.
Our Mission
“To provide breakthrough research works to our clients through Perseverant efforts towards creativity and innovation”.
Vision
Writekraft endeavours to be the leading global research and publications company that will fulfil all research needs of our clients. We will achieve this vision through:
Analyzing every customer’s aims, objectives and purpose of research
Using advanced and latest tools and technique of research and analysis
Coordinating and including their own ideas and knowledge
Providing the desired inferences and results of the research
In the past decade, we have successfully assisted students from various universities in India and globally. We at Writekraft Research & Publications LLP head office in Kanpur, India are most trusted and professional Research, Writing, Guidance and Publication Service Provider for PhD. Our services meet all your PhD Admissions, Thesis Preparation and Research Paper Publication needs with highest regards for the quality you prefer.
Writekraft Research and Publications LLP was initially formed, informally, in 2006 by a group of scholars to help fellow students. Gradually, with several dissertations, thesis and assignments receiving acclaim and a good grade, Writekraft was officially founded in 2011 . Since its establishment, Writekraft Research & Publications LLP is Guiding and Mentoring PhD Scholars.
“LET US KNOW ABOUT QUALITY BY DESIGN IN PHARMACEUTICAL INDUSTRY”Rajatmishra137
The Impression of Quality by configuration protects by demonstrating that quality is simply not a demonstration, yet it is a propensity. As of late Quality by structure (QbD) has increased a lot of consideration among the pharmaceutical business in extremely short course of time . It goes about as a connection between the business and medication administrative specialists for example (FDA), which is predominantly founded on logical, chance based, all encompassing and proactive methodology for advancement of pharmaceutical item. QbD has helped in making the new detailing, and furthermore the structuring of new method of medication conveyance, just as the better approaches for assembling procedure, and attempts to guarantee the predefined quality items . Key attributes of QbD are that it gives an apparatus to centered and effective medication improvement. It is pertinent to diagnostic strategies. Key components of the Quality by configuration are The Quality Target Product Profile (QTPP), Critical Quality Attributes (CAQ), Design space, Control procedure, lifecycle the executives . Use of value by configuration is in different new looks into dependent on HPLC technique, and we give quit estimation of medication conveyance as indicated by the patients BMR , additionally in Quality by Design in Biopharmaceuticals .
Opportunities of BDS in Pharmaceutical Industries.pptxDr. Manoj Kumbhare
India is the second-largest pharmaceutical market in Asia. ... A BDS graduate can have various job roles available in this sector: Principal Investigator, Co-investigator, Medical Advisor, Drug Developer, Regulatory Affairs Manager or even a Clinical Research Physician.
Career opportunities in the clinical research field are many and varied, with employment settings ranging from pharmaceutical and biotechnology, to medical device companies, contract research organizations, hospitals, educational institutions, independent contractors and more.
Many professionals with a strong science or healthcare related background — such as nurses, pharmacists, medical technologists, physicians and more — are well-positioned to join the clinical research field. Here are 10 career paths in the field.
Similar to Challenges in the changing pharmaceutical (20)
Vastu is the exact science but some people have connected it with the orthodox practices to misguide the people.Vastu is based on the following principles of science:
1. Principle of energy flow
2. Principle of open space
3. Principle of shapes
4. Principle of angles
5. Principle of directions
6. Principle of gravity(Mass)
7. Principle of height
8. Principle of slope
9. Principle of placement of rooms
10.Principle of elements
9.
Sai Pharma Solutions Inc. has has been instrumental in providing services on consultation and turnkey project basis in Regulatory Affairs, Quality Management and GMP compliance since 2008. We offer consultation and undertake turnkey projects in development and implementation of Quality Systems which incorporates Regulatory Affairs, Quality and cGMP documentation, DMF and Dossier Management, SOP Management, Technical and Scientific Advice management, Validation and Qualification Management, Gap Analysis, Review, Assessment, Audits and Training. Our clientele includes the upcoming and existing pharmaceutical industries. We are known for the best"QQS" worldwide. The quality of our work speaks volumes about our efforts and endeavours".
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
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
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- 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
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
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
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
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
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.
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
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.
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.
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
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
1. Challenges in the Changing Pharmaceutical
Regulatory Scenario In India
Keeping in pace with the Indian Pharmaceutical Industry is one of pharmaceutical regulatory bodies have
the largest and most advanced among the also come out with major changes. This
international regulatory developing countries. It has over the years initiative by the Indian regulatory bodies
scenario, the Indian made significant progress in infrastructure will play a pivotal role to put India on
development, technological capability and the top of the pharmaceutical map of
pharmaceutical regulatory hence produced a wide range of products. the world. In pursuance of the same,
bodies have come out with Understanding the regulatory scenario in they have published guidelines on the
major changes, which will this sector is extremely crucial not only following topics and now they are in the
due to the rapid and ongoing changes at implementation stage and they are going
play a pivotal role to put the global level, largely with reference to to bring about revolutionary changes in the
India on the top of the Good Manufacturing Practices (GMP), Indian Pharmaceutical Industry.
Good Clinical Practices (GCP) and Good
pharmaceutical map of Laboratory Practices (GLP) but also due Good Manufacturing Practices (Current
the world. In pursuance to the onus on the regulatory bodies to Schedule M)
of the same, the article ensure a healthy supply of quality drugs at
affordable prices to the Indian masses. GMP aims to ensure that drugs and other
describes the guidelines, pharmaceutical products are safe and
implementation and The Industry today is in the front rank of effective. Since then, Good Manufacturing
India’s science-based industries with wide Practices (GMP) has been considered a
revolutionary changes
ranging capabilities in the complex field of seal of quality for pharmaceutical products.
bring by the Indian drug manufacture and technology. It ranks GMP has been adopted by many countries
Regulatory in the domestic very high in the third world, in terms of worldwide and that includes India which
technology, quality and range of medicines is now the second largest producer of
Pharmaceutical Industry. manufactured. From simple headache pills pharmaceutical products in the world.
to sophisticated antibiotics and complex
cardiac compounds, almost every type The revised Schedule M advises proper
of medicine is now made indigenously. pressure differentials in the areas of operation,
Playing a key role in promoting and which can be achieved through dedicated
sustaining development in the vital field air handling units with adequate number of
“
“
The Indian Pharmaceutical Industry will have to
go a long way for the successful compliance of
current Schedule M
of medicines, Indian Pharmaceutical air changes. These pressure differentials
Industry boasts of quality producers will help to eliminate/reduce the chances of
and many units approved have been by cross contamination between the products.
regulatory authorities in USA, Japan, EU, In addition to these, revised schedule M
Canada, Australia and UK. Now there is emphasises proper cleaning validation of
no such country in the world where Indian the equipment and the processing areas
manufactured pharmaceutical products are whenever there is product change over. It
not available. is also mandatory to display status boards
Dr. J Ramniwas of each equipment material to avoid mix-
CEO
Keeping in pace with the international ups, which leads to cross contamination.
Sai Pharma Solutions Inc, Vadodara
regulatory scenario, the Indian Current Schedule M also gives importance
28 June 2012 Pharma Bio World
2. “
The current GCP guidelines of India are at par
with ICH guidelines of GCP and these guidelines
would open new vistas to companies who want
“ investigators and premiere medical
institutes available in the country along
with considerable low per patient trial
cost, as compared to developed countries.
The current GCP guidelines of India are
at par with ICH guidelines of GCP and
to locate their clinical programme in this country. these guidelines would open new vistas to
companies who want to locate their clinical
programme in this country. However, this
to the stability study of drug substances and industries in India. On the other hand, WHO is very challenging but helps making a
drug products to claim the re-test date and eyes towards every small aspects of and niche in the clinical trial business with
expiry date. The Government of India has related to the laboratory procedure with a global acceptance.
recognised Pharmaceutical Industry as a view to assure the output scientifically proof.
technology-driven industry and is focusing on Drug Registration and Regulatory
the growth of the industry both for domestic Schedule L1 Good Laboratory Practices Submission Guidelines
as well as for the expanding global markets. (GLP) requirements are applicable to
To create a confidence about the quality laboratories attached to all manufacturers Drugs defined as New Drugs under the
of drug manufactured in this country, it is covered under rules 74 and 78 of Drugs Drugs and Cosmetics Act are subjected
essential that the regulators of the country & Cosmetics Rules, which include to bioavailability/bioequivalence (BA/BE)
define standard, which are on par with global manufacture of ‘medical devices’, evaluations through clinical trials, which
standards through proper legislation. ‘diagnostic reagents’, ‘surgical dressings are reviewed by the Drugs Controller
such as gauges and bandages’, General (India). A drug has a New Drug
The Indian Pharmaceutical Industry will ‘disinfectant fluids’ and ‘sanitising fluids’, status for four years from the date of first
have to go a long way for the successful etc and hold licenses in forms 25 and permission. After four years, the State
compliance of current schedule M but 28. These laboratories even though tiny Licensing Authority grants license but they
once compliance is achieved, the Indian sized, shall be in conformity with all GLP do not insists for BA/BE and clinical trial
pharmaceutical industry will be able to requirements even laboratories attached to studies which are essential to establish
beat any GMP global standard. Change the manufacturing units too. the efficacy of the drugs. Central Drugs
can be good or difficult at times; this Standard Control Organisation (CDSCO)
largely depends on how prepared a person This will be particularly useful to the has come out with new draft guidelines on
or an organisation is to adapt and survive laboratories that already comply with the the approval of clinical trials and new drugs.
with the new set up. Apparently, the requirements of Schedule L1 and want to
small players in India’s pharmaceutical move ahead towards WHO compliance. CDSCO has decided to adopt Common
companies have to buckle down to be Technical Document (CTD) format for
more equipped with the changes that Good Clinical Practices (GCP) technical requirements for registration
GMP brings into their businesses. of pharmaceutical products for human
Clinical research is the key to the use. The same is in use for biological
Good Laboratory Practices (Schedule L1) discovery of latest diagnostic methods and products since 2009 and now this guidance
to develop modern drugs for treatment of document describes the format for
The Drugs & Cosmetics Rules were diseases. Good Clinical Practices (GCP) preparation of CTD for marking approval
amended to incorporate Schedule L1 is an ethical and scientific quality standard of pharmaceuticals for human use other
on Good Laboratory Practices and for designing, conducting and recording than biological products. It is apparent
Requirements of premises and Equipments trials that involve the participation of that Indian Pharmaceutical Regulatory
published under notification GSR 780 (E) human subjects. Compliance with this bodies will be able to expedite the review
dated 10 th November 2010; a period of two standard provides assurance to public that process of new drug application marketing
years was granted for the Pharmaceutical the rights, safety and well being of trial approval. These guidelines are applicable
industry to make necessary arrangement subjects are protected, consistent with the to for import, manufacture and marketing
to comply with the requirement of Schedule principles enshrined in the Declaration of approval of new drug applications.
L1 before these are made mandatory. Helsinki and ensures that clinical trial data
is credible. The adoption of Drug Master File (DMF)
Rules laid by Schedule L1 are terse and and drug product dossier concepts CTD
minimum with an objective to improve the It has been widely recognised that India format in tune with the global requirements
reliability of data without much adding to offers unique opportunities for conducting will help the Indian pharmaceutical Industry
the cost to the company, particularly for clinical trials in view of the large patient to contribute production and speedy entry
the small to medium scale pharmaceutical pool, well-trained and enthusiastic to the global markets and simultaneously
Pharma Bio World June 2012 29
3. Indian patients would also receive to adapt its business model to recent development concept and Quality
quality and safe medicines. The Indian changes in the operating environment. design has become the buzzword in
Regulatory Agencies and Regulatory the pharmaceutical world and to that
Affairs professionals will be of immense India’s Patents Act should ensure that India is no exception. The US Food and
importance to address these challenges it does not exceed the requirements of Drug Administration (FDA) is planning
in the right perspective to make Indian Trade-Related Aspects Of Intellectual to make the submission of Quality by
Pharmaceutical Manufacturers competent Property Rights (TRIPS), and that Design (QbD) document mandatory
and regulatory savvy. prioritizes access to medicines and for all the New Drug Application (NDA)
public health, while retaining the right applicants from January 2013. All the
Pharmacovigilance Programme of India to participate in the compulsory license manufacturers exporting to the US,
(PvPI) for Assuring Drug Safety scenario. India should lead a movement will now have to submit an entire set
of developing nations and create a of documents supporting their product,
The CDSCO, Directorate General of Trade-Related Aspects Of Intellectual right from its inception stage to the
Health Services, under the aegis of Property Rights (TRIPS) south and G-20 US regulatory authority while filing for
Ministry of Health & Family Welfare, alliance is a step in that direction. approval. The documents submitted
Government of India, in collaboration should support the companies claim
with Indian Pharmacopeia commission Price Control on how effective and efficacious their
(IPC), Ghaziabad is initiating a product is from the design stage itself.
nation-wide Pharmacovigilance programme The Pharmaceutical Price Control Policy Failing which there are chances of
for protecting the health of the patients by carried forward earlier governmental their application being rejected by the
assuring drug safety. The programme shall initiatives in terms of ensuring quality FDA officials.
be coordinated by the IPC, Ghaziabad as a drugs at reasonable prices, strengthening
National Coordinating Centre (NCC). The of indigenous capability for cost-effective QbD is a concept that is introduced by
centre will operate under the supervision production, reducing trade barriers the US FDA with an aim to understand
of a Steering Committee. and providing active encouragement to the design and development of the
in-house R&D efforts of domestic firms. pharmaceutical formulations and
Since, there are considerable social and The objective is to increase revenue and manufacturing processes to help ensure
economic consequences of Adverse Drug lower prices of medicines by using fiscal quality of the end product. On this
Reactions (ADRs) there is a need to deterrent on Maximum Retail Price (MRP). occasion, the International Pharmaceutical
engage health-care professionals, in a well Excipients Council (IPEC) has urged all the
structured programme to build synergies This change may have had some impact Indian manufacturers exporting to the US
for monitoring ADRs. The purpose of the in terms of magnifying the advantage to update and prepare themselves on the
Pharmacovigilance Programme of India is to industries located in the excise free procedural requirements so that they will
to collect, collate and analyse data to arrive zones. This also succeeded in attracting not be taken by surprise while filing any
at an inference to recommend regulatory some small pharmaceutical firms to these NDA applications.
interventions, besides communicating risks zones. This development indicates the
to healthcare professionals and the public. heightened sensitivity of the government Design of Experiments (DOE) is the most
towards consumer access to medicines at effective method to achieve product and
IPR Issues Concerning Global Pharma reasonable prices and keeping a check on pro¬cess efficiency and optimisation.
Market profit mongering by the industry. Design of Experiment (DOE) studies
can help develop process development
As per World Trade Organization (WTO), In addition to the Quality (GMP, GLP, knowledge by revealing relationships,
from the year 2005, India granted product GCP), Intellectual Property Rights (IPR) including multifactorial interactions,
patent recognition to all New Chemical and drug price control change initiative between the variable inputs (e.g.,
Entities (NCEs) i.e., bulk drugs developed by the Indian Pharmaceutical Regulatory component characteristics or processing
then onwards. This introduction of Agencies, the Indian Pharmaceutical parameters) and the resulting outputs
product patent regime from January 2005 manufacturers will have to face the (e.g., in-process material, intermediates,
is leading into long-term growth for the challenges in the subsequent areas to or the final product).
future, which mandated patent protection remain in completion in to the global
on both products and processes for a market, which are listed below: The application of Quality by Design
period of 20 years. Under this new law, principles is beginning to be well
India will be forced to recognise not only • Quality by Design – New Perspective to established in the pharmaceutical industry.
new patents but also any patents filed Product Development: With the advent In particular, the demonstration of the
after January 1, 1995. Under changed of ICH-Q8 and ICH-Q11, guidelines science and risk-based approaches being
environment, the industry is being forced have revolutionised the product applied to specific subsets of the drug
30 June 2012 Pharma Bio World
4. “
product design or processing has been
discussed intensively during the past
several years. Therefore, it is now time to
widen the scope of QbD across multiple unit
operations, including important aspects of
With the advent of ICH-Q8 and ICH-Q11, guidelines
have revolutionised the product development
concept and Quality design has become the
“
the drug substance.
buzzword in the pharmaceutical world.
Model development and implementation
is a core principle to employing a QbD
approach in drug product design and Flexible facility design will contribute to monitoring. Pharmacy profession should
process scale-up. The advantages in reduced financial risk as products progress orient concept of pharmacy practice at
taking this approach are realised through from Phase 1 to Phase 3. Traditional community and hospital pharmacies through
the ease of visualisation or mathematical approaches require investment of millions appropriate training and compensation.
expression of data sets for greater process of dollars into a facility for a product to
understanding, which leads to clear be manufactured in the hope that the The pharmacy profession will make the clinical
decision making and results in superior candidate will succeed in Phase 3 testing. trial industry in India to grow to over a billion
product quality. While agile and adaptable facility designs dollars in the next five years and position itself
will become more widespread, dedicated as a destination of choice for CRO services
There are several model types that can be manufacturing facilities will still be required by way of strict implementation of patent
developed and used at every stage in the under certain conditions, including laws, single window clearance of clinical trial
QbD process. A favored approach is to large-volume products with high API and/ protocols by regulatory clearances and shall
begin with the end in mind by outlining up or drug product demands, manufacture of accord industry status to this sector. India will
front a clear plan toward model design and highly potent or toxic drug substances, and emerge as a major global player in the field
development for the drug product process, the need for specialised processes. of pharmaceuticals exports and as a provider
considering how each model will be used, of quality medicines at low costs. It shall
limitations, assumptions, qualification, and The Indian pharmaceutical industry shall also emerge as a major player in the generic
maintenance. The experimental approach ensure that essential drugs at affordable drugs market in USA and Europe. India shall
to the development of each model should prices are available to the vast population attain new heights in herbal drugs research
consider the type of model (mechanistic of this sub-continent and also continue in shaping Indian Systems of Medicine into a
or empirical), selected variables, scale providing employment for millions. popular system of medicine of the future for
dependency and relationship to the overall India shall implement all the rules and holistic health care and ensuring health care for
drug product process. Once a model has regulations, which guide, monitor and all - especially for the welfare of the poor.
been developed, steps are needed toward control the activities of the providers of
implementation through qualification of the healthcare system in the country and The focus of Indian Pharmaceutical
the model and evaluating uncertainty in shall examine the way to bring them up to Regulatory bodies is now shifting towards
predictions. Finally, for models selected international standards. the risk management and science based
for use in commercial manufacture, a GMP regulations with the affordability of
maintenance plan is needed to support The government should implement the quality medicines. The need of the hour
product life cycle. recommendations of Mashelkar committee is to change the attitude by the Indian
and constitute the Central Drug Authority at the Pharmaceutical Manufactures from 'What
• New Concept in Facility Design: earliest. The basic course of education should will happen to others, will also happen to
Manufacturing plants will increasingly be designed to ensure that the newly qualified me' to 'We resolve to make our industries
utilise modular building strategies. pharmacist has the necessary knowledge and compliant to regulatory requirements
Facilities will include disposable skills to commence practicing competently in by converting industries research and
process equipment, enclosed clean a variety of settings including community and innovation driven'. This too is true that when
rooms around process equipment, and hospital pharmacy and the pharmaceutical our intentions are clear and our efforts are
lean design concepts. This approach industry. Continuing professional development consistent in the right direction, nothing
provides significant cost savings must then be a lifelong commitment for every is impossible.
and reduces start-up time frames for practicing pharmacist.
new facilities. Designing outcomes All changes and challenges are always
into manufacturing processes via Concept of National schools of pharmacy tough but facing them with determination
quality-by-design concepts will should be established to develop and yields a long lasting success!
be critical to reducing costs, introduce model curriculum. Pharmacists
increasing efficiencies, and assuring should become knowledgeable to participate Contact: jramniwas@saipharmasolutions.
regulatory compliance. in medication management and outcome com
Pharma Bio World June 2012 31