The document provides an overview of pharmaceutical guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It lists the various ICH guidelines organized under the categories of Quality, Safety, Efficacy, and Multidisciplinary guidelines. The guidelines address topics like stability testing, analytical validation, impurities, clinical safety and pharmacovigilance, biopharmaceutics, and electronic standards.
FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. A presentation compiled from material freely available on the WEB to introduce the concepts of QbD for beginners.
GMP is the part of Quality Management which ensures that the products are consistently produced and controlled to the quality standard appropriate to their intended use as required by the marketing authorization and product specification. (Reference: WHO)
In contrast, cGMP i.e. ‘c’ before the GMP is indicative of the constantly changing technologies and systems which are up-to-date in order to comply with the regulations. These the dynamic changes in Good Manufacturing Practice to make Pharmaceuticals manufacture foul proof; assuring a high level of confidence in the safety and efficacy of the product.
FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. A presentation compiled from material freely available on the WEB to introduce the concepts of QbD for beginners.
GMP is the part of Quality Management which ensures that the products are consistently produced and controlled to the quality standard appropriate to their intended use as required by the marketing authorization and product specification. (Reference: WHO)
In contrast, cGMP i.e. ‘c’ before the GMP is indicative of the constantly changing technologies and systems which are up-to-date in order to comply with the regulations. These the dynamic changes in Good Manufacturing Practice to make Pharmaceuticals manufacture foul proof; assuring a high level of confidence in the safety and efficacy of the product.
Site Master File or SMF is a document in the pharmaceutical industry which provides information about the production and control of manufacturing operations. The document is created by a manufacturer.
It's a document prepared by the manufacturer containing specific and factual GMP information about the production and/or control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, the site master file need describe only those operations, e.g., analysis, packaging.
Presentatio on IPQC for Capsules by Akshay Trivedi
Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality requirements".[1]
This approach places an emphasis on three aspects (enshrined in standards such as ISO 9001)[2][3]:
Elements such as controls, job management, defined and well managed processes,[4][5] performance and integrity criteria, and identification of records
Competence, such as knowledge, skills, experience, and qualifications
Soft elements, such as personnel, integrity, confidence, organizational culture, motivation, team spirit, and quality relationships.
Inspection is a major component of quality control, where physical product is examined visually (or the end results of a service are analyzed). Product inspectors will be provided with lists and descriptions of unacceptable product defects such as cracks or surface blemishes for example.[3]
The quality of the outputs is at risk if any of these three aspec
Modern humans are distinguished from other species by their extensive use of tools to control and adapt to their surroundings. Early stone tools such as anvils had no holes and were not designed as interchangeable parts. Mass production established processes for the creation of parts and system with identical dimensions and design, but these processes are not uniform and hence some customers were unsatisfied with the result. Quality control separates the act of testing products to uncover defects from the decision to allow or deny product release, which may be determined by fiscal constraints.[6] For contract work, particularly work awarded by government agencies, quality control issues are among the top reasons for not renewing a contract.[7]
The simplest form of quality control was a sketch of the desired item. If the sketch did not match the item, it was rejected, in a simple Go/no go procedure. However, manufacturers soon found it was difficult and costly to make parts be exactly like their depiction; hence around 1840 tolerance limits were introduced, wherein a design would function if its parts were measured to be within the limits. Quality was thus precisely defined using devices such as plug gauges and ring gauges. However, this did not address the problem of defective items; recycling or disposing of the waste adds to the cost of production, as does trying to reduce the defect rate. Various methods have been proposed to prioritize quality control issues and determine whether to leave them unaddressed or use quality assurance techniques to improve and stabilize production.[6]
Notable approaches
Introduction
Brief description of the drug and the therapeutic class to which it belongs
Chemical and pharmaceutical information
Animal Pharmacolog
Animal Toxicology
Human/Clinical Pharmacology phase I
Therapeutic exploratory trials (Phase II)
Therapeutic confirmatory trials (Phase III)
Special Studies Geriatrics, pediatrics, pregnant or nursing women
Regulatory status in other countries
Prescribing information
Samples and Testing Protocol/s
In this slide contains a ICH guideleine for Quality, Safety , Efficacy and Multidisciplinary
Quality
Guidelines
Safety Guidelines
Efficacy Guidelines
Multidisciplinary
Guidelines
Site Master File or SMF is a document in the pharmaceutical industry which provides information about the production and control of manufacturing operations. The document is created by a manufacturer.
It's a document prepared by the manufacturer containing specific and factual GMP information about the production and/or control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, the site master file need describe only those operations, e.g., analysis, packaging.
Presentatio on IPQC for Capsules by Akshay Trivedi
Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality requirements".[1]
This approach places an emphasis on three aspects (enshrined in standards such as ISO 9001)[2][3]:
Elements such as controls, job management, defined and well managed processes,[4][5] performance and integrity criteria, and identification of records
Competence, such as knowledge, skills, experience, and qualifications
Soft elements, such as personnel, integrity, confidence, organizational culture, motivation, team spirit, and quality relationships.
Inspection is a major component of quality control, where physical product is examined visually (or the end results of a service are analyzed). Product inspectors will be provided with lists and descriptions of unacceptable product defects such as cracks or surface blemishes for example.[3]
The quality of the outputs is at risk if any of these three aspec
Modern humans are distinguished from other species by their extensive use of tools to control and adapt to their surroundings. Early stone tools such as anvils had no holes and were not designed as interchangeable parts. Mass production established processes for the creation of parts and system with identical dimensions and design, but these processes are not uniform and hence some customers were unsatisfied with the result. Quality control separates the act of testing products to uncover defects from the decision to allow or deny product release, which may be determined by fiscal constraints.[6] For contract work, particularly work awarded by government agencies, quality control issues are among the top reasons for not renewing a contract.[7]
The simplest form of quality control was a sketch of the desired item. If the sketch did not match the item, it was rejected, in a simple Go/no go procedure. However, manufacturers soon found it was difficult and costly to make parts be exactly like their depiction; hence around 1840 tolerance limits were introduced, wherein a design would function if its parts were measured to be within the limits. Quality was thus precisely defined using devices such as plug gauges and ring gauges. However, this did not address the problem of defective items; recycling or disposing of the waste adds to the cost of production, as does trying to reduce the defect rate. Various methods have been proposed to prioritize quality control issues and determine whether to leave them unaddressed or use quality assurance techniques to improve and stabilize production.[6]
Notable approaches
Introduction
Brief description of the drug and the therapeutic class to which it belongs
Chemical and pharmaceutical information
Animal Pharmacolog
Animal Toxicology
Human/Clinical Pharmacology phase I
Therapeutic exploratory trials (Phase II)
Therapeutic confirmatory trials (Phase III)
Special Studies Geriatrics, pediatrics, pregnant or nursing women
Regulatory status in other countries
Prescribing information
Samples and Testing Protocol/s
In this slide contains a ICH guideleine for Quality, Safety , Efficacy and Multidisciplinary
Quality
Guidelines
Safety Guidelines
Efficacy Guidelines
Multidisciplinary
Guidelines
Key importance of ICH guideline, a brief summary on the international guidelines for new drug development.
Specifically for regulatory affairs student of MPharm
ICH is stand for the “International Conference on Harmonization of Technical Requirement for Pharmaceuticals for Human Use”
Goal of ICH. ICH Guidelines.
Q (Quality) S (Safety)
Related to chemical & pharmaceutical Quality Assurance ( Stability Testing, Impurity Testing etc.)
Related to in vitro & in vivo pre-clinical studies (Carcinogenicity Testing, genotoxicity Testing, etc.)
Stability testing of new drug substances and products.
Validation of Analytical Procedures : Text & Methodology
Regulatory Acceptance of Analytical Procedure &Acceptance Criteria (RAAPAC)
Carcinogenicity Studies (S1A-S1C)
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development. ICH’s mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. On 23 October 2015, ICH announced organisational changes as it marks 25 years of successful harmonisation.
ISO 14644-1.pptx.Cleanrooms and associated controlled environmentsNazim Hussain
ISO 14644 consists of the following parts, under the general title Cleanrooms and associated controlled environments:
Part 1: Classification of air cleanliness by particle concentration
Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
Part 3: Test methods
Part 4: Design, construction and start-up
Part 5: Operations
Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
Part 8: Classification of air cleanliness by chemical concentration (ACC)
Part 9: Classification of surface cleanliness by particle concentration
Part 10: Classification of surface cleanliness by chemical concentration
Cleanrooms and associated controlled environments provide for the control of contamination of air and, if appropriate, surfaces, to levels appropriate for accomplishing contamination-sensitive activities. Contamination control can be beneficial for protection of product or process integrity in applications in industries such as aerospace, microelectronics, pharmaceuticals, medical devices, healthcare and food.
This part of ISO 14644 specifies classes of air cleanliness in terms of the number of particles expressed as a concentration in air volume. It also specifies the standard method of testing to determine cleanliness class, including selection of sampling locations.
This edition is the result of a response to an ISO Systematic Review and includes changes in response to user and expert feedback validated by international enquiry. The title has been revised to “Classification of air cleanliness by particle concentration” to be consistent with other parts of ISO 14644. The nine ISO cleanliness classes are retained with minor revisions. Table 1 defines the particle concentration at various particle sizes for the nine integer classes. Table E.1 defines the maximum particle concentration at various particle sizes for intermediate classes. The use of these tables ensures better definition of the appropriate particle-size ranges for the different classes. This part of ISO 14644 retains the macroparticle descriptor concept; however, consideration of nano-scale particles (formerly defined as ultrafine particles) will be addressed in a separate standard.
The most significant change is the adoption of a more consistent statistical approach to the selection and the number of sampling locations; and the evaluation of the data collected. The statistical model is based on adaptation of the hypergeometric sampling model technique, where samples are drawn randomly without replacement from a finite population. The new approach allows each location to be treated independently with at least a 95 % level of confidence that at least 90 % of the cleanroom or clean zone areas will comply with the maximum particle concentration limit for the target class of air cleanliness.
Water for Pharmaceutical Use........pptxNazim Hussain
Pharmaceutical water production, storage and distribution systems should be designed, installed, commissioned, qualified and maintained to ensure the reliable production of water of an appropriate quality.for pharmaceutical water systems.
Annex 1: Development of monographs for The International Pharmacopoeia Annex 2: WHO good manufacturing practices: water for pharmaceutical use Annex 3: Pharmaceutical development of multisource (generic) pharmaceutical products - point to consider
Annex 4: Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part.
Annex 5: Development of paediatric medicines: points to consider in formulation
Annex 6: Recommendations for quality requirements for artemisinin as a starting material in the production of antimalarial active pharmaceutical ingredient.
Inspection of water systems
8.2 The following list identifies items and a logical sequence for a WPU system inspection or audit:
– a current drawing of the water system showing all equipment in the system from the inlet to the points of use along with sampling points and their designations;
– approved piping drawings (e.g. orthographic and/or isometric);
– a sampling and monitoring plan with a drawing of all sample points;
– training programme for sample collection and testing;
– the setting of monitoring alert and action levels;
– monitoring results and evaluation of trends;
– inspection of the last annual system review;
– review of any changes made to the system since the last audit and a check that the change control has been implemented;
– review of deviations recorded and their investigation;
– general inspection of system for status and condition;
– review of maintenance, failure and repair logs;
– checking calibration and standardization of critical instruments
Code of Federal Regulations (CFR)...pptxNazim Hussain
Code of Federal Regulations (CFR).CFR is the codification of the general and permanent regulations promulgated by the executive departments and agencies of the federal government of the United States.
The CFR is divided into 50 titles that represent broad areas subject to federal regulation.
The titles are broken down into chapters, parts, sections and paragraphs.
Recruitment
Recruitment includes those practices and activities carried on by the organization with the primary purpose of identifying and attracting potential employees.
(Barber’s 1998}
Sources of recruitment
Internal sources
External sources
External recruitment is the assessment of an available pool of job candidates, other than existing staff, to see if there are any sufficiently skilled or qualified to fill and perform existing job vacancies.
It is the process of searching outside of the current employee pool to fill open positions in an organization.
External recruitment is the assessment of an available pool of job candidates, other than existing staff, to see if there are any sufficiently skilled or qualified to fill and perform existing job vacancies.
It is the process of searching outside of the current employee pool to fill open positions in an organization.
External recruitment is the assessment of an available pool of job candidates, other than existing staff, to see if there are any sufficiently skilled or qualified to fill and perform existing job vacancies.
It is the process of searching outside of the current employee pool to fill open positions in an organization.
Methods of external recruitment sourcesMedia advertisement
Employment exchanges
Employment agencies
Educational institutions
Recommendation
Platform manufacturing is the implementation of standard technologies, systems and work practices within manufacturing facilities, and their use for the manufacture of different products
Platform technologies are considered a valuable tool to improve efficiency and quality in drug product development. The basic idea is that a platform, in combination with a risk-based approach, is the most systematic method to leverage prior knowledge for a given new molecule. Furthermore, such a platform enables a continuous improvement by adding data for every new molecule developed by this approach, increasing the robustness of the platform
Technology was lauded as the savior of the drug discovery and development (DDD) process during the late 1990s. A myriad of independent companies developed and offered ‘innovative’ tools, technologies and platforms (TTPs) to pharmaceutical companies in order to mitigate the time, cost and risk of developing new therapeutic drugs.
The words tool, technology and platform are often used interchangeably. However, in the biotech and DDD sectors a single tool is a component item (think hammer on a carpenter’s tool-belt), which when combined together constitute a technology (think carpenter’s tool-belt). A combination of technologies, when applied in a cohesive manner, can be labelled as a platform (think the carpenter him/herself complete with tool-belt, safety glasses, mode of transportation etc).
In this, we use such relationships to provide a general perspective on what constitutes a platform, whether it is technological, biological, molecular or digital in nature.
The words tool, technology and platform are often used interchangeably. However, in the biotech and DDD sectors a single tool is a component item (think hammer on a carpenter’s tool-belt), which when combined together constitute a technology (think carpenter’s tool-belt). A combination of technologies, when applied in a cohesive manner, can be labelled as a platform (think the carpenter him/herself complete with tool-belt, safety glasses, mode of transportation etc).
In this, we use such relationships to provide a general perspective on what constitutes a platform, whether it is technological, biological, molecular or digital in nature.
Tabros Pharma is one of the leading companies in pharmaceutical sector of Pakistan and named among the Top National companies of the country. The company was established in 1971 and since the day of its inception, the company has grown rapidly and on regular basis. The company is equipped with the up to date and state of the art machinery and equipment to produce the high quality products within the strict regulation and controls of CGMP
It is related to apple Inc. Vision & Mission Statement:
There are no official or written statements of vision or mission on apple website but different statements of CEO or press release may be the vision or mission of Apple. There is no specific area for vision and mission as there are no clarifications about the vision and mission.
VISION STATEMENT : (Future positon ideas)
We strive to provide users of Apple products the best experiences possible though innovative product designs and software
MISSION STATEMENT:
Not all market shares are equal, and Apple has never been about the most; we are about being the best.
We believe that we are on the face of the earth to make great products and that’s not changing.
We are constantly focusing on innovating.
We believe in the simple not the complex. (only selected initial 3 statement by Tim)SWOT ANALYSIS:
STRENGTHS:
Safety of personal data.
Pioneer in the personal desktop computer.
Max market capitalization.
High performance production line with products like iphone, ipad, ipd, mac computer.
WEAKNESS:
15% global market show.
Significantly expensive.
Not compatible with many software and windows machine
Late production of Larger screen in smart phone.
OPPERTUNITIES:
Apple pays finger prints
In-house credit system
Product diversification
Formation of strategic partnerships
THREATS
Patent infringement
Reverse packaging
Quality problems with negative effects on sales and Apple brand image
Intense competition like Samsung, Lenovo, Chinese companies in smart phone. Dell, Sony and Toshiba in PCs.
Rising popularity of Google Android may affect its market share.
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
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
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
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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.
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
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
2. Pharmaceutical Guidelines
ICH Guidelines
The ICH topics are divided into the four categories below and ICH topic
codes are assigned according to these categories.
Quality Guidelines Safety Guidelines
Efficacy Guidelines Multidisciplinary Guidelines
3. Pharmaceutical Guidelines
ICH
Q1 Stability( Q1A-Q1F)
• ICH Q1A (R2) Stability testing of new drug substances and drug products
• ICH Q1B Photostability testing of new active substances and medicinal products
• ICH Q1C Stability testing: requirements for new dosage forms
• ICH Q1D Bracketing and matrixing designs for stability testing of drug substances
and drug products
• ICH Q1E Evaluation of stability data
• ICH Q1F Stability data package for registration in climatic zones III and IV -
explanatory note
5. Pharmaceutical Guidelines
ICH
Q3 Impurities
• ICH Q3A (R2) Impurities in new drug substances
• ICH Q3B (R2) Impurities in new drug products
• ICH Q3C (R5) Residual solvents
• ICH Q3D Elemental impurities
6. Pharmaceutical Guidelines
ICH
Q4 Regulatory Acceptance
• ICH Q4B Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions
• ICH Q4B Annex 1 Residue on ignition/sulphated ash
• ICH Q4B Annex 2 Test for extractable volume in parenteral preparations
• ICH Q4B Annex 3 Test for particulate contamination: sub-visible particles
• ICH Q4B Annex 4A Microbiological examination of non-sterile products: microbial enumeration tests
• ICH Q4B Annex 4B Test for microbiological examination of non-sterile products: tests for specified
micro-organisms
• ICH Q4B Annex 4C Test for microbiological examination of non-sterile products: acceptance criteria
for pharmaceutical preparations and substances for pharmaceutical use
• ICH Q4B Annex 5 Disintegration test
7. Pharmaceutical Guidelines
ICH
Q4 Regulatory Acceptance
• ICH Q4B Annex 6 Uniformity of dosage unites general chapter
• ICH Q4B Annex 7 Dissolution test
• ICH Q4B Annex 8 Sterility test
• ICH 4 QB Annex 9 Tablet friability
• ICH Q4B Annex 10 Polyacrylamide gel electrophoresis
• ICH Q4B Annex 11 Capillary electrophoresis
• ICH Q4B Annex 12 Analytical sieving
• ICH Q4B Annex 13 Bulk density and tapped density of powders
• ICH Q4B Annex 14 Bacterial endotoxins tests
8. Pharmaceutical Guidelines
ICH
Q6 Specifications
• ICH Q6A Specifications: test procedures and acceptance criteria for
new drug substances and new drug products: chemical substances
• ICH Q6B Test procedures and acceptance criteria for
biotechnological/biological products
9. Pharmaceutical Guidelines
ICH
• ICH Q7 Good manufacturing practice for active pharmaceutical
ingredients
• ICH Q8 (R2) Pharmaceutical development
• Q9 ICH Q9 Quality risk management
• ICH Q10 Pharmaceutical quality system
• ICH Q11 Development and manufacture of drug substances
(chemical entities and biotechnological/biological entities)
• ICH Q12 Technical and regulatory considerations for pharmaceutical
product lifecycle management
10. Pharmaceutical Guidelines
ICH
Safety
Carcinogenicity studies
• ICH S1 Regulatory notice on changes to core guideline on rodent
carcinogenicity testing of pharmaceuticals
• ICH S1A Need for carcinogenicity studies of pharmaceuticals
• ICH S1B Carcinogenicity: testing for carcinogenicity of
pharmaceuticals
• ICH S1C (R2) Dose selection for carcinogenicity studies of
pharmaceuticals
12. Pharmaceutical Guidelines
ICH
Safety
Toxicokinetics and pharmacokinetics
• ICH S3A Toxicokinetics: the assessment of systemic exposure in
toxicity studies
• ICH S3A Toxicokinetics: the assessment of systemic exposure in
toxicity studies - questions and answers
• ICH S3B Pharmacokinetics: repeated dose tissue distribution
studies
13. Pharmaceutical Guidelines
ICH
Safety
Repeat-dose toxicity
• ICH S4 Duration of chronic toxicity testing in animals (rodent and
non-rodent toxicity testing)
Reproductive toxicology
• ICH S5 (R2) Reproductive toxicology: detection of toxicity to
reproduction for medicinal products including toxicity to male
fertility
Biotechnological products
• ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived
pharmaceuticals
14. Pharmaceutical Guidelines
ICH
Safety
Toxicokinetics and pharmacokinetics
• ICH S3A Toxicokinetics: the assessment of systemic exposure in
toxicity studies
• ICH S3A Toxicokinetics: the assessment of systemic exposure in
toxicity studies - questions and answers
• ICH S3B Pharmacokinetics: repeated dose tissue distribution
studies
15. Pharmaceutical Guidelines
ICH
Safety
Safety pharmacology studies
• ICH S7A Safety pharmacology studies for human pharmaceuticals
• ICH S7B Non-clinical evaluation of the potential for delayed
ventricular repolarization (QT interval prolongation) by human
pharmaceuticals
Immunotoxicology studies
• ICH S8 Immunotoxicity studies for human pharmaceuticals
17. Pharmaceutical Guidelines
ICH
Efficacy
Clinical safety
• ICH E1 Population exposure: the extent of population exposure to assess clinical
safety
• ICH E2A Clinical safety data management: definitions and standards for expedited
reporting
• ICH E2B (R3) Electronic transmission of individual case safety reports (ICSRs) -
data elements and message specification - implementation guide
• ICH E2C (R2) Periodic benefit-risk evaluation report
• ICH E2D Post-approval safety data management
• ICH E2E Pharmacovigilance planning (Pvp)
• ICH E2F Development safety update report
18. Pharmaceutical Guidelines
ICH
Efficacy
Clinical study report
• ICH E3 Structure and content of clinical study reports
Dose response studies
• ICH E4 Dose response information to support drug registration
Ethnic factors
• ICH E5 (R1) Ethnic factors in the acceptability of foreign clinical data
• ICH E5(R1) Ethnic factors in the acceptability of foreign clinical data -
questions and answers
Good clinical practice
• ICH E6 (R2) Good clinical practice
19. Pharmaceutical Guidelines
ICH
Efficacy
Clinical trials
• ICH E7 Studies in support of special populations: geriatrics
• ICH E8 General considerations for clinical trials
• ICH E9 Statistical principles for clinical trials
• ICH E10 Choice of control group in clinical trials
• ICH E11(R1) step 5 guideline on clinical investigation of medicinal products in the
pediatric population
• ICH E17 Guideline on general principles for planning and design of multi-regional
clinical trials
• ICH E18 Guideline on genomic sampling and management of genomic data
20. Pharmaceutical Guidelines
ICH
Efficacy
Clinical evaluation by therapeutic category
• ICH E12 Principles for clinical evaluation of new antihypertensive drugs
Clinical evaluation
• ICH E14 Clinical evaluation of QT/QTc interval prolongation and proarrhythmic
potential for non-antiarrhythmic drugs
• ICH E14 (R3) Clinical evaluation of QT/QTc interval prolongation and
proarrhythmic potential for non-antiarrhythmic drugs - questions and answers
• ICH E15 Definitions for genomic biomarkers, pharmacogenomics,
pharmacogenetics, genomic data and sample coding categories
• ICH E16 Genomic biomarkers related to drug response: context, structure and
format of qualification submissions
21. Pharmaceutical Guidelines
ICH
Multidisciplinary
M1 MedDRA Terminology
• M1 MedDRA-Medical Dictionary for Regulatory Activities (MedDRA)
• M1 PtC WG MedDRA points to considers
M2 Electronic Standards
• M2 EWGElectronic Standards for the Transfer of Regulatory Information
M3 Nonclinical Safety Studies
• M3(R2)Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical
Trials and Marketing Authorization for Pharmaceuticals
• M3(R2) Q&As (R2)Questions & Answers: Guidance on Nonclinical Safety Studies
for the Conduct of Human Clinical Trials and Marketing Authorization for
Pharmaceuticals
22. Pharmaceutical Guidelines
ICH
Multidisciplinary
• M8 Electronic Common Technical Document (eCTD)
• M9 Biopharmaceutics Classification System-based Biowaivers
• M10 Bioanalytical Method Validation and Study Sample Analysis
• M11 Clinical electronic Structured Harmonised Protocol (CeSHarP)
• M12 Drug Interaction Studies
• M13 Bioequivalence for Immediate-Release Solid Oral Dosage
Forms
• M14 Use of real-world data for safety assessment of medicines
• M15 General Principles for Model-Informed Drug Development
