cGMP refers to the Current Good Manufacturing Practice regulations imposed by the FDA.
cGMP assures proper design, monitoring and control of manufacturing processes and facilities in the herbal drug industry.
WHO to provide technical support to develop a methodology to
monitor or ensure the quality, efficacy and safety of traditional
medicine and its products.
To promote and improve the quality of herbal medicines and
also to reduce the proportion of adverse effect caused by the
poor quality of herbal medicines.
Medicinal plants besides therapeutic agents are also a big source of information for a wide variety of chemical constituents which could be developed as drugs with precise selectivity.
Podophyllum resin is a mixture of resins obtained from the rhizomes and roots of the herbaceous plant Podophyllum hexandrum Royle (P. emodi Wall.) or P. peltatum L. after percolation with ethanol and precipitation from water or very dilute acids.
Research Guidline safety & efficacy of herbal drug.pptxEasy Concept
The Research guidelines for evaluating the safety and efficacy of herbal medicines are intended to facilitate the work of research scientists and clinicians in this field and to furnish some reference points for the governmental, industrial and non-profit organizations that provide financial support for their work.
It must be emphasized that these guidelines are offered as a summary of scientific standards governing various aspects of the study of herbal medicines.
Role of chemical & biological marker.pptxEasy Concept
Increased herbal medicines use and lack of effective regulatory control, the safety of herbal medicines has become a key priority issue. Herbal drug technology is used for converting botanical materials into medicines, where standardization and quality control with proper integration of modern scientific techniques and traditional knowledge is important.
According to regulatory guidelines and pharmacopoeias macroscopic and microscopic evaluation and chemical profiling of the botanical materials is used for quality control and standardization.
Quality control of pharmaceutical formulations is an essential operation in the production of drugs. It is a procedure or set of procedures designed to ensure the output of uniform batches of drugs conforms to the established specifications.
Quality control is concerned with both quality and quantity. The quality of pharmaceutical dosages forms must be built in during plant construction, product research and development, purchasing of materials, production, testing, inspection, packaging, labelling, storage, and distribution.
The WHO guidelines on good agricultural and collection practices (GACP) for medicinal plants are mainly intended to provide general technical guidance on obtaining medicinal plant materials of good quality for the sustainable production of herbal products classified as medicines.
The European Medicines Agency's (EMAs) Committee for herbal medicinal products for human and veterinary use prepares scientific guidelines in consultation with
regulatory authorities in the European Union (EU) Member States, to help applicants prepare marketing authorization applications for human and veterinary medicines.
GMP Requirements & Drug & Cosmetic Act Provision.pptxEasy Concept
Good Manufacturing Practices (GMP) is that part of quality assurance, which ensures that products are regularly produced and controlled according to the quality standards suitable for their use.
(GMP) comes in Schedule M in D & C Act 1940 and Rules 1945.
GMPs are the requirements that the drug and methods/control /facilities used in their manufacturing, processing and packaging conforms to practice that will assure the safety and efficacy of the product.
WHO to provide technical support to develop a methodology to
monitor or ensure the quality, efficacy and safety of traditional
medicine and its products.
To promote and improve the quality of herbal medicines and
also to reduce the proportion of adverse effect caused by the
poor quality of herbal medicines.
Medicinal plants besides therapeutic agents are also a big source of information for a wide variety of chemical constituents which could be developed as drugs with precise selectivity.
Podophyllum resin is a mixture of resins obtained from the rhizomes and roots of the herbaceous plant Podophyllum hexandrum Royle (P. emodi Wall.) or P. peltatum L. after percolation with ethanol and precipitation from water or very dilute acids.
Research Guidline safety & efficacy of herbal drug.pptxEasy Concept
The Research guidelines for evaluating the safety and efficacy of herbal medicines are intended to facilitate the work of research scientists and clinicians in this field and to furnish some reference points for the governmental, industrial and non-profit organizations that provide financial support for their work.
It must be emphasized that these guidelines are offered as a summary of scientific standards governing various aspects of the study of herbal medicines.
Role of chemical & biological marker.pptxEasy Concept
Increased herbal medicines use and lack of effective regulatory control, the safety of herbal medicines has become a key priority issue. Herbal drug technology is used for converting botanical materials into medicines, where standardization and quality control with proper integration of modern scientific techniques and traditional knowledge is important.
According to regulatory guidelines and pharmacopoeias macroscopic and microscopic evaluation and chemical profiling of the botanical materials is used for quality control and standardization.
Quality control of pharmaceutical formulations is an essential operation in the production of drugs. It is a procedure or set of procedures designed to ensure the output of uniform batches of drugs conforms to the established specifications.
Quality control is concerned with both quality and quantity. The quality of pharmaceutical dosages forms must be built in during plant construction, product research and development, purchasing of materials, production, testing, inspection, packaging, labelling, storage, and distribution.
The WHO guidelines on good agricultural and collection practices (GACP) for medicinal plants are mainly intended to provide general technical guidance on obtaining medicinal plant materials of good quality for the sustainable production of herbal products classified as medicines.
The European Medicines Agency's (EMAs) Committee for herbal medicinal products for human and veterinary use prepares scientific guidelines in consultation with
regulatory authorities in the European Union (EU) Member States, to help applicants prepare marketing authorization applications for human and veterinary medicines.
GMP Requirements & Drug & Cosmetic Act Provision.pptxEasy Concept
Good Manufacturing Practices (GMP) is that part of quality assurance, which ensures that products are regularly produced and controlled according to the quality standards suitable for their use.
(GMP) comes in Schedule M in D & C Act 1940 and Rules 1945.
GMPs are the requirements that the drug and methods/control /facilities used in their manufacturing, processing and packaging conforms to practice that will assure the safety and efficacy of the product.
Comparison of various herbal pharmacopoeias.pptxEasy Concept
Herbal Pharmacopoeia is a reference book for the preparation of quality medicines published by the authority of a Government and represents qualitative and therapeutic monographs on botanicals
Good Manufacturing Practices (GMP) is that part of quality assurance, which ensures that products are regularly produced and controlled according to the quality standards suitable for their use.
Herbal drugs are considered to be adulterated if GMPs are not met.
Quality control of herbal medicines aims to ensure their consistency, safety and efficacy.
Chemical fingerprinting has been demonstrated to be a powerful technique for the quality control of herbal medicines.
Preparation of documents for Export regd..pptxEasy Concept
A manufacturer holding valid license copy in Form-25 & Form-
28 can obtain No Objection Certificate from Zonal/Sub Zonal
offices of Central Drugs Standard Control Organization (CDSCO) for export purpose only for approved/unapproved new Drugs / banned drug from India.
In this video Quality assurance parameters has been discussed for herbal medicines in herbal drug industry. The Current Good Manufacturing of Herbal Products also covered. What kinds of area is suitable for herbal plant, water supply, Exhaust facility, storage requirements etc explained.
Video link :
https://youtu.be/9T82HALfpy8
Portion Disscussed :
1. Guidelines on Good Manufacturing Practices for the Manufacture of Herbal Medicines
2. Quality assurance in the manufacture of herbal medicines
3. Good manufacturing practice for herbal medicines
4. Sanitation and hygiene in herbal Drug Industry
5. Qualification and validation in herbal Drug Industry
6. Complaints in herbal Drug Industry
7. Product recalls in herbal Drug Industry
8. Contract production and analysis in herbal Drug Industry
9. Self-inspection in herbal Drug Industry
10. Personnel in herbal Drug Industry
11. Training in herbal Drug Industry
12. Personal hygiene in herbal Drug Industry
13. Premises for herbal Drug Industry
14. Storage areas in herbal Drug Industry
15. Production areas in herbal Drug Industry
16. Equipment in herbal Drug Industry
17. Materials in herbal Drug Industry
18. Reference samples and standards in herbal Drug Industry
19. Packaging materials and labeling in herbal Drug Industry
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.
Basic test for drugs - Pharmaceutical SubstanceEasy Concept
The main ingredient in a medicine that cause the desire effect of the medicine.
Some medicine contain more than one pharmacologic substance that act in different way in the body.
It is unique in bringing together the regulatory authorities and
pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.
GLP is a quality system concerned with the organizational process and the conditions, under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.
Application of chromatography Technique in standardization of herbal drugEasy Concept
Chromatography is defined as a technique of isolation and identification of components or compounds or mixture into individual components by using the stationary phase and mobile phase. Plant materials are separated and purified by using various chromatographic techniques.
Quality control of herbal medicines aims to ensure their consistency, safety and efficacy.
Chemical fingerprinting has been demonstrated to be a powerful technique for the quality control of herbal medicines.
Regulatory requirements for herbal medicines: Herbal medicines are different from other types of medicines. The approval process is also different from other medicines. AYUSH Ministry given guidelines for approval of herbal medicines.
Query Solved
1. Regulatory requirements for herbal medicines
2. Herbal Medicines ke liye regulatory requirements
3. AYUSH ka important role in Herbal medicines launch
4. D and C act role in Herbal medicines
5. What are important steps to launch herbal medicines
Role of Markers in Standardization of Herbal ProductsDr-Jitendra Patel
In this Power Point Presentation the viewer will be able to know the the different markers present naturally in herbal materials. These markers may be genitally, chemically and biochemically. How markers play major role during identification, authentication, quality control, quality assurance and determination of safety and efficacy of particular medicinal plant.
Portion covered:
1. Role of markers in standardization of herbal products
2. Factor influencing identification and quality of herbal Drugs
3. Meaning of Standardization
4. Types of Markers
5. Molecular or DNA Markers
6. Chemical Markers
7. Biochemical Markers
Quality management systems - INDUSTRIAL PHARMACY llJafarali Masi
syllabus
Quality management & Certifications: Concept of Quality, Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP
Quality assurance (QA) is a way of preventing mistakes and defects in manufactured products and avoiding problems when delivering products or services to customers.
Comparison of various herbal pharmacopoeias.pptxEasy Concept
Herbal Pharmacopoeia is a reference book for the preparation of quality medicines published by the authority of a Government and represents qualitative and therapeutic monographs on botanicals
Good Manufacturing Practices (GMP) is that part of quality assurance, which ensures that products are regularly produced and controlled according to the quality standards suitable for their use.
Herbal drugs are considered to be adulterated if GMPs are not met.
Quality control of herbal medicines aims to ensure their consistency, safety and efficacy.
Chemical fingerprinting has been demonstrated to be a powerful technique for the quality control of herbal medicines.
Preparation of documents for Export regd..pptxEasy Concept
A manufacturer holding valid license copy in Form-25 & Form-
28 can obtain No Objection Certificate from Zonal/Sub Zonal
offices of Central Drugs Standard Control Organization (CDSCO) for export purpose only for approved/unapproved new Drugs / banned drug from India.
In this video Quality assurance parameters has been discussed for herbal medicines in herbal drug industry. The Current Good Manufacturing of Herbal Products also covered. What kinds of area is suitable for herbal plant, water supply, Exhaust facility, storage requirements etc explained.
Video link :
https://youtu.be/9T82HALfpy8
Portion Disscussed :
1. Guidelines on Good Manufacturing Practices for the Manufacture of Herbal Medicines
2. Quality assurance in the manufacture of herbal medicines
3. Good manufacturing practice for herbal medicines
4. Sanitation and hygiene in herbal Drug Industry
5. Qualification and validation in herbal Drug Industry
6. Complaints in herbal Drug Industry
7. Product recalls in herbal Drug Industry
8. Contract production and analysis in herbal Drug Industry
9. Self-inspection in herbal Drug Industry
10. Personnel in herbal Drug Industry
11. Training in herbal Drug Industry
12. Personal hygiene in herbal Drug Industry
13. Premises for herbal Drug Industry
14. Storage areas in herbal Drug Industry
15. Production areas in herbal Drug Industry
16. Equipment in herbal Drug Industry
17. Materials in herbal Drug Industry
18. Reference samples and standards in herbal Drug Industry
19. Packaging materials and labeling in herbal Drug Industry
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.
Basic test for drugs - Pharmaceutical SubstanceEasy Concept
The main ingredient in a medicine that cause the desire effect of the medicine.
Some medicine contain more than one pharmacologic substance that act in different way in the body.
It is unique in bringing together the regulatory authorities and
pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.
GLP is a quality system concerned with the organizational process and the conditions, under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.
Application of chromatography Technique in standardization of herbal drugEasy Concept
Chromatography is defined as a technique of isolation and identification of components or compounds or mixture into individual components by using the stationary phase and mobile phase. Plant materials are separated and purified by using various chromatographic techniques.
Quality control of herbal medicines aims to ensure their consistency, safety and efficacy.
Chemical fingerprinting has been demonstrated to be a powerful technique for the quality control of herbal medicines.
Regulatory requirements for herbal medicines: Herbal medicines are different from other types of medicines. The approval process is also different from other medicines. AYUSH Ministry given guidelines for approval of herbal medicines.
Query Solved
1. Regulatory requirements for herbal medicines
2. Herbal Medicines ke liye regulatory requirements
3. AYUSH ka important role in Herbal medicines launch
4. D and C act role in Herbal medicines
5. What are important steps to launch herbal medicines
Role of Markers in Standardization of Herbal ProductsDr-Jitendra Patel
In this Power Point Presentation the viewer will be able to know the the different markers present naturally in herbal materials. These markers may be genitally, chemically and biochemically. How markers play major role during identification, authentication, quality control, quality assurance and determination of safety and efficacy of particular medicinal plant.
Portion covered:
1. Role of markers in standardization of herbal products
2. Factor influencing identification and quality of herbal Drugs
3. Meaning of Standardization
4. Types of Markers
5. Molecular or DNA Markers
6. Chemical Markers
7. Biochemical Markers
Quality management systems - INDUSTRIAL PHARMACY llJafarali Masi
syllabus
Quality management & Certifications: Concept of Quality, Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP
Quality assurance (QA) is a way of preventing mistakes and defects in manufactured products and avoiding problems when delivering products or services to customers.
Six system inspection is a part of pharmaceutical.management system.this presentation gives the information about production, facilities and equipment, quality, laboratory,packaging and material system.
Pharmaceutical Good Manufacturing PracticesPharmaceutical
When you are in healthcare, Then GMP is must. Regulatory philosophy for product Quality have been changed from "Quality by Testing QbT" to "Quality by Design QbD". Quality is to be built in product and that only can be done by GMP.
Quality Assurance and Quality Management System, QUALITY CONTROL
cGMP (GOOD MANUFACTURING PRACTICES
ELEMENTS OF QUALITY MANAGEMENT SYSTEM
PURPOSES OF QUALITY MANAGEMENT SYSTEMS
CONCEPT OF QUALITY ASSURANCE
RESPONSIBILITIES OF QA
GMP COVERS
In a welcome move, the Pharmacy Council of India has recently re-structured the syllabus of the
Bachelor of Pharmacy course. In the effort to make the content more relevant to the practice of
pharmacy in its current form, we now find new, important subjects introduced, and Pharmaceutical
Quality Assurance is one of them.
Optimization is selecting the most suitable element from available resources considering all the factors which influence decisions in any experiment.
In the pharmaceutical industry, optimization has always meant changing one variable at a time to solve a problem formulation.
To improve formulation irregularities, modern pharmaceutical optimization uses a systematic design of experiments (DoE).
Quality by Design enhances the assurance of safe and effective drugs to consumer and promise to improve manufacturing quality performance and also product free of contamination and gives the desired benefit as in the label to the consumer.
Pharmacovigilance & WHO Drug Monitoring Program.pptxEasy Concept
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem.
Community health is also the subset of public health that is taught to and practiced by clinicians.
Community health volunteers & community health workers work with primary care providers to facilitate entry into, exit from and utilization of the formal health system by community members.
The FDA requires that all primary and secondary packaging materials be suitable for their intended use. “Suitable for intended use” means that the packaging should not only protect the product’s form of dosage, but also be compatible with that dosage form.
It’s also required that primary and secondary packaging be made of a material that’s considered safe to use, both with the product’s administration route and its form of dosage.
Quality control of packaging material.pptxEasy Concept
The selection of package begins with determination of products physical & chemical characteristics.
Quality control of a packaging component starts at design stage. All the aspects of a pack development may give rise to quality problems. It must be identified & minimized by performing quality control tests.
Packaging is the art of science & technology of enclosing or protecting products for distribution , storage, sale & use.
Packaging is the process by which the pharmaceuticals are suitably placed so that they should retain their therapeutic effectiveness from the time of their packaging till they are consumed.
Packaging is the art of science & technology of enclosing or protecting products for distribution , storage, sale & use.
Pharmaceutical packaging can be defined as the economical means of providing presentation, protection, identification, information, convenience compliance, integrity & stability of the product.
Universal Immunization Programme (UIP), started in India in 1985.
Ministry of Health & Family Welfare provides several vaccines to infants, children & pregnant women through UIP.
Immunization is a process through which a person is made immune to an infectious disease.
Polio is a viral disease that destroys the nerve cells present in the spinal cord causing paralysis or muscle weakness to some part of the body.
Pulse Polio Programme was launched in 1995 after a resolution for a global initiative of polio eradication was adopted by World Health Assembly (WHA) in 1988.
Health is defined as state of complete Physical,
Mental and Social well being.
It involves more than just the absence of disease.
According these concept- Health means absence of disease.
This concept is based on ‘Germ Theory’
Human body as a machine and disease is an outcome of the breakdown of the machine, and doctors tasks was to repair the machine.
A Good Agricultural Practice of medicinal plants is a cultivation program designed to ensure optimal yield in terms of both the quality and quantity of any crop intended for health purposes.
ICH stands for “International Conference For Harmonization Of Technical Requirements For Pharmaceutical For Human Use” brings together the medicines regulatory authorities and pharmaceutical industry around the world.
The purpose of stability testing is to provide evidence on how the quality of a drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity & light.
Quality control of herbal medicines aims to ensure their consistency, safety and efficacy.
Chemical fingerprinting has been demonstrated to be a powerful technique for the quality control of herbal medicines.
Crude drugs are extracted with solvents in their increasing order of polarity (from non-polar to polar), In this procedure, the active constituents, which are soluble with specific range of polarity, get extracted in the solvent and the remaining marc is further extracted with the following solvent.
Non -ionic surfactants and their applicationEasy Concept
surfactant, also called surface-active agent, substance such as a detergent that, when added to a liquid, reduces its surface tension, thereby increasing its spreading and wetting properties.
Surfactants are termed as surface-active agents also wetting agents, emulsifying agents or suspending agents depending on its properties and use.
Surfactants are compounds that lower the surface tension between two liquids, between a gas & liquids, or between a liquid & a solid.
These are diluents or fillers designed to make up the required bulk of the tablet.
These are inactive ingredients that are added to tablets in addition to the active drug.
Some very common diluents in tablet include lactose their derivatives, starch, cellulose derivatives.
Used in the direct compression the tablets.
The purpose of stability testing is to provide evidence on how the quality of a drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity & light.
Herbal Medicinal Products have a number of characteristics that clearly differentiate them from chemically defined medicinal products & therefore specific stability guidelines needed to be established.
In accelerated stability testing the samples are subjected to stress, refrigerated after stressing, & then assayed simultaneously.
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.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
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.
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.
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
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
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.
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
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
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3. cGMP refers to the Current Good Manufacturing Practice
regulations imposed by the FDA.
cGMP assures proper design, monitoring and control of
manufacturing processes and facilities in the herbal drug
industry.
It also includes establishing strong quality management
systems, obtaining the right quality of raw materials,
establishing robust operating procedures, detecting and
investigating product quality and maintaining reliable testing
laboratories.
It helps to prevent contamination, mix-ups, deviations, failures
and errors.
Thus, assures that drug products meet the Current Good
Manufacturing Practice regulations.
INTRODUCTION
4. →cGMP regulations assure that quality is built into the design and manufacturing
process at every step.
→ Manufacturing facilities are in good condition.
→ Equipment's are properly maintained and calibrated.
→ Employees are qualified and fully trained.
→ Processes that are reliable and reproducible.
Objective Of cGMP
5. Guidelines On cGMP
Production
System
Facilities &
Equipment
Systems
Packaging &
Labelling System
Laboratory Control
System
Material System
The FDA’s drug manufacturing inspection compliance program contains instructions to FDA
personnel for conducting inspections, is a systems-based approach to inspection and is
very consistent with the robust quality system model presented in this guidance.
Relationship between six system :
6. Quality System
Every pharmaceutical product has to establish identity, strength, purity and other
quality characteristics to ensure the required levels of safety and effectiveness. It
includes all product defect evaluations and evaluation of returned and salvaged
drug products.
Production System
This system includes measures and activities to control the manufacture of drugs
and drug products including batch compounding, dosage form production, in-
process sampling and testing and process validation. It also includes establishing,
following and documenting the performance of approved manufacturing
procedures.
Guidelines On cGMP
7. Facilities & Equipment System
This includes the measures and activities which provide a proper physical
environment and resources used in the production of the drugs or drug products.
It includes:
→ Buildings and facilities along with maintenance.
→ Equipment qualifications (installation and operation).
→ Equipment calibration and preventative maintenance.
→ Cleaning and validation of cleaning processes.
Laboratory Control System
This system includes measures and activities related to laboratory procedures,
testing, analytical methods development and validation or verification, and the
stability program.
Guidelines On cGMP
8. Material System
It includes measures and activities to control finished products, components
including water or gases that are incorporated into the product, containers and
closures. It also includes validation of computerized inventory control, processes,
drug Storage, distribution controls and records.
Packaging and Labelling System
This system includes measures and activities that control the packaging and
labeling of drugs and drug products. It includes written procedures, label
examination and usage, label storage and issuance, packaging and labeling
operations controls and validation of these operations.
Guidelines On cGMP
9. THANKS!
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