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.
A platform is a group of technologies that are used as a base
or infrastructure upon which other applications, technologies
or processes are developed for the end-user.
“a common or standard method, equipment, procedure or work practice that may be applied to the research, development or manufacturing of different products ” An array of multi-disciplinary technologies covering major aspects of the drug discovery and development processes have been established in Institute of Biotechnology and Pharmaceutical Research (IBPR)
Technology Transfer in Pharma Industry, Technology Transfer in Pharmaceutical Industry, Pharmaceutical Technology Transfer, Pharma Tech Transfer, Naseeb basha, Pharmaceutical Tech Transfer, Naseeb basha Technology Transfer in Pharma Industry, Naseeb basha Pharmaceutical Technology Transfer
A platform is a group of technologies that are used as a base
or infrastructure upon which other applications, technologies
or processes are developed for the end-user.
“a common or standard method, equipment, procedure or work practice that may be applied to the research, development or manufacturing of different products ” An array of multi-disciplinary technologies covering major aspects of the drug discovery and development processes have been established in Institute of Biotechnology and Pharmaceutical Research (IBPR)
Technology Transfer in Pharma Industry, Technology Transfer in Pharmaceutical Industry, Pharmaceutical Technology Transfer, Pharma Tech Transfer, Naseeb basha, Pharmaceutical Tech Transfer, Naseeb basha Technology Transfer in Pharma Industry, Naseeb basha Pharmaceutical Technology Transfer
Technology transfer by Zade Manasi S. M pharm 1st yr, Bharati vidyapeeth College of pharmacy, Kolhapur .
1. Introduction :-Technology transfer is the practice of transferring scientific findings from one organization to another for further development.
Which is mainly concerned with the transfer of technology from research areas to “Production and Quality Assurance” environment.
The process by which existing knowledge, facilities or capabilities developed under R & D are utilized to fulfil public and private need.
Technology transfer is the intersection between business, science, engineering, law and government.
Definition :-Transfer of technology is defined as “a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacture sites” .
3. Objective :-To offer guidance & assistance to inventors & corporation.
-To provide a hands-on learning opportunity.
-To increase the general awareness.
-To accelerate scale-up and cost reduction.
4. Development of technology from Research & D to production :-R&D provides technology transfer dossier (TTD) document to product development laboratory, which contains all information of formulation and drug product as follows-
Master Formula Card (MFC)– Includes product name along with its strength, generic name, MFC number, page number, effective date, shelf life and market.
Master Packing Card– Gives information about packaging type, material used for packaging, stability profile and shelf life of packaging.
Master Formula–
5. Success of technology transfer :-It depends on :-
-Communication
-Open communication between all team members
-Direct communication between technical members
-Effective and timely communication with regulators
*Sending and Receiving Unit
- Technology transfer is not a “one way street”
The sending unit and receiving unit must be equally involved in the process to ensure success
-Team work at all time
6. Checklist for technology transfer :-It consists of:
Production master formula.
Manufacturing and Dispensing instructions.
Analytical methods.
Cleaning instructions and previous cleaning validation.
Active specifications and source.
Primary packaging material specifications and source.
Packaging instructions.
Process deviations file, Analytical deviations file.
Specimen manufacturing batch record.
7. Technology transfer team :- The technology transfer team consists of :
Process Technologist
QA Representative
Production Representative
Engineering representative
QC Representative
8. Steps in technology transfer process :-A] Development of technology by R&D( Reaserch Phase):
(a) Design of procedure and selection of excipients by R&D
(b) Identification of specifications and quality by R&D
B] Technology transfer from R&D to production (Development Phase):
(a)Master Formula Card (MFC)
(b) Master Packing Card
(c) Master Formula
(d) Specifications
Challenges in ramp-up process according to the findings in articles, Ishikawa analsis for the challenges in ramp-up. Strategies to overcome the mentioned challenges and appopriate ramp-up categories for the strategies.
References are given.
A Critical Technology Element (CTE) is a new or novel technology that a platform or system depends on to achieve successful development or production or to successfully meet a system operational threshold requirement. Technology Readiness Levels (TRL) are a method of estimating technology maturity of CTE of a program during the Acquisition Process. They are determine during a Technology Readiness Assessment (TRA) that examines program concepts, technology requirements, and demonstrated technology capabilities.
Advanced manufacturing technology
Advanced manufacturing technology refers to applying more improved technology to optimize production. The technology process relates to production equipment and procedures used by manufacturing companies (Stornelli, Ozcan, & Simms, 2021). There are various examples of advanced manufacturing, such as composite or advanced materials, that ensure that glass, plastics, ceramics, and other specific cocktails of metals serve a particular application.
The participants involved in the manufacturing process of turning raw materials into final goods using tools, machinery, chemical processing, and human labor include; Engineers, production managers, CEOs, heads of sections, and junior employees. During the manufacturing process, the responsibility of the engineers is to identify the areas that need improvement, design new products, and various processes, and maintain high levels of manufacturing and high-quality products. On the other hand, the production managers oversee the day-to-day operations of manufacturing by coordinating, planning, and directing activities used to create a wide range of goods such as computer equipment, cars, and others.
The primary purpose of justification for the advanced manufacturing technology is to provide organizations with the opportunity to improve the quality of their manufacturing products to succeed in the business (Roca & O'Sullivan, 2020). That is because the advanced manufacturing capability can be determined by many employees and the processes that provide a good match and offer consistent products of high quality and at a lower price Advanced manufacturing technology is one of the modern ways of production where sophisticated and highly automated and computerized systems are incorporated in the production processes. Advanced manufacturing technologies aim to ensure quality products at low costs within a short period (Bai & Sarkis, 2017). The manufacturing sector is the strength of any industrialized nation. Even though a more significant percentage of the population might be unemployed in the service industries, the manufacturing industry is responsible for producing the nation’s wealth.
technology transfer of liquid oral and supac guidelines ASHISH SUTAR
logical procedure that controls the transfer of any process together with its documentation and professional expertise between developments or between manufacture sites.
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
Technology transfer by Zade Manasi S. M pharm 1st yr, Bharati vidyapeeth College of pharmacy, Kolhapur .
1. Introduction :-Technology transfer is the practice of transferring scientific findings from one organization to another for further development.
Which is mainly concerned with the transfer of technology from research areas to “Production and Quality Assurance” environment.
The process by which existing knowledge, facilities or capabilities developed under R & D are utilized to fulfil public and private need.
Technology transfer is the intersection between business, science, engineering, law and government.
Definition :-Transfer of technology is defined as “a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacture sites” .
3. Objective :-To offer guidance & assistance to inventors & corporation.
-To provide a hands-on learning opportunity.
-To increase the general awareness.
-To accelerate scale-up and cost reduction.
4. Development of technology from Research & D to production :-R&D provides technology transfer dossier (TTD) document to product development laboratory, which contains all information of formulation and drug product as follows-
Master Formula Card (MFC)– Includes product name along with its strength, generic name, MFC number, page number, effective date, shelf life and market.
Master Packing Card– Gives information about packaging type, material used for packaging, stability profile and shelf life of packaging.
Master Formula–
5. Success of technology transfer :-It depends on :-
-Communication
-Open communication between all team members
-Direct communication between technical members
-Effective and timely communication with regulators
*Sending and Receiving Unit
- Technology transfer is not a “one way street”
The sending unit and receiving unit must be equally involved in the process to ensure success
-Team work at all time
6. Checklist for technology transfer :-It consists of:
Production master formula.
Manufacturing and Dispensing instructions.
Analytical methods.
Cleaning instructions and previous cleaning validation.
Active specifications and source.
Primary packaging material specifications and source.
Packaging instructions.
Process deviations file, Analytical deviations file.
Specimen manufacturing batch record.
7. Technology transfer team :- The technology transfer team consists of :
Process Technologist
QA Representative
Production Representative
Engineering representative
QC Representative
8. Steps in technology transfer process :-A] Development of technology by R&D( Reaserch Phase):
(a) Design of procedure and selection of excipients by R&D
(b) Identification of specifications and quality by R&D
B] Technology transfer from R&D to production (Development Phase):
(a)Master Formula Card (MFC)
(b) Master Packing Card
(c) Master Formula
(d) Specifications
Challenges in ramp-up process according to the findings in articles, Ishikawa analsis for the challenges in ramp-up. Strategies to overcome the mentioned challenges and appopriate ramp-up categories for the strategies.
References are given.
A Critical Technology Element (CTE) is a new or novel technology that a platform or system depends on to achieve successful development or production or to successfully meet a system operational threshold requirement. Technology Readiness Levels (TRL) are a method of estimating technology maturity of CTE of a program during the Acquisition Process. They are determine during a Technology Readiness Assessment (TRA) that examines program concepts, technology requirements, and demonstrated technology capabilities.
Advanced manufacturing technology
Advanced manufacturing technology refers to applying more improved technology to optimize production. The technology process relates to production equipment and procedures used by manufacturing companies (Stornelli, Ozcan, & Simms, 2021). There are various examples of advanced manufacturing, such as composite or advanced materials, that ensure that glass, plastics, ceramics, and other specific cocktails of metals serve a particular application.
The participants involved in the manufacturing process of turning raw materials into final goods using tools, machinery, chemical processing, and human labor include; Engineers, production managers, CEOs, heads of sections, and junior employees. During the manufacturing process, the responsibility of the engineers is to identify the areas that need improvement, design new products, and various processes, and maintain high levels of manufacturing and high-quality products. On the other hand, the production managers oversee the day-to-day operations of manufacturing by coordinating, planning, and directing activities used to create a wide range of goods such as computer equipment, cars, and others.
The primary purpose of justification for the advanced manufacturing technology is to provide organizations with the opportunity to improve the quality of their manufacturing products to succeed in the business (Roca & O'Sullivan, 2020). That is because the advanced manufacturing capability can be determined by many employees and the processes that provide a good match and offer consistent products of high quality and at a lower price Advanced manufacturing technology is one of the modern ways of production where sophisticated and highly automated and computerized systems are incorporated in the production processes. Advanced manufacturing technologies aim to ensure quality products at low costs within a short period (Bai & Sarkis, 2017). The manufacturing sector is the strength of any industrialized nation. Even though a more significant percentage of the population might be unemployed in the service industries, the manufacturing industry is responsible for producing the nation’s wealth.
technology transfer of liquid oral and supac guidelines ASHISH SUTAR
logical procedure that controls the transfer of any process together with its documentation and professional expertise between developments or between manufacture sites.
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
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.
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.
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.
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
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
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
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
2. What is platform
technology?
• 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.
3. DEFINITION
Platform manufacturing is the
implementation of standard
technologies, systems and work
practices within manufacturing
facilities, and their use for the
manufacture of different
products
4. • 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.
Integrated Platform Drug Discovery and
Development
7. Example:
• 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.
8. Main
benefits of an
established
platform
process
include:
• Reduction in process development effort,time and
cost.
• Consistency in process performance and Product
quality.
• Simplification of technology transfer activities to
production facilities.
• Raw materials and consumables are standardized.
• Prior platform data informs risk assessments on new
process weak-points,and focuses development effort
where most needed.
Reduced personnel training burden owing to similar
processes and equipment.
• Reduction in failure rates during manufacturing due to
accumulated process experience.
• Improved speed through repetition.
9. Pre-requisite to establish a
technology platform for early
development
• Target molecule profile
• Candidate screening and selection:
