Drugtesting
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Developing new drugs is a long and expensive process that takes 10-12 years and costs $500 million on average. Potential drugs are first tested in laboratories and then on animals to test safety and effectiveness before clinical trials begin with human volunteers. Clinical trials involve three phases of testing on increasing numbers of patients to further evaluate safety and efficacy. If a drug successfully completes all phases of clinical trials and regulatory approval, it can then be licensed and prescribed by doctors, while continued monitoring occurs after market release.
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Stages of drug development
This document outlines the stages of drug development, beginning with drug discovery and ending with regulatory approval. It discusses the history of drug development from ancient times to modern pharmaceutical industry. The key stages are described as pre-clinical development involving non-human testing, clinical development involving human trials to test safety and efficacy, and regulatory approval. Drug discovery involves target identification, validation, lead discovery through screening, and lead optimization to improve desired properties. Recent advances like genomics, high-throughput screening, and bioinformatics have accelerated the drug development process.
Drug development process
The document discusses the process of new drug development, which involves several lengthy and costly stages. In preclinical testing, potential drug candidates are screened in animal and laboratory testing to evaluate toxicity, safety, and efficacy. If successful, compounds enter clinical trials involving 4 phases with human subjects to further assess safety and effectiveness. Only about 1-2% of initially investigated compounds ultimately result in an approved drug. The entire process from discovery to regulatory approval can take over 12 years and cost over $1 billion. Rigorous testing and regulatory standards aim to bring only safe and effective drugs to market.
Drug discovery and development
The document discusses the process for approval of a new drug from development through marketing. It takes 10-15 years on average and costs over $2.6 billion to get a new drug approved. Key steps include:
- Preclinical research to identify biological targets and compounds
- FDA approval to begin clinical trials in three phases involving thousands of subjects to test safety, efficacy, and dosing
- New Drug Application submission including all clinical trial data for FDA review and approval
- Post-marketing studies and generic approval after patents expire
1. Unit I - new drug discovery and development.
The document summarizes the stages of drug discovery and development. It begins with drug discovery, which involves understanding disease pathways and identifying drug targets. Lead compounds are then identified and optimized. Preclinical testing assesses safety. If successful, an investigational new drug application is filed and clinical trials proceed in four phases, from initial safety testing to large efficacy trials. If approved, post-marketing monitoring continues to assess long-term safety. The process aims to bring safe and effective therapies to patients while adhering to regulatory standards.
Regulation of herbal drugs in india
The document discusses the regulatory status of herbal drugs in India. It outlines that herbal drugs are regulated under the Drug and Cosmetic Act of 1940 and Rules of 1945. The Department of AYUSH is the regulatory authority that requires manufacturing and marketing licenses. It also discusses definitions, licensing procedures, good manufacturing practices, labeling requirements, and guidelines set by AYUSH.
Clinical studies
Clinical trials have multiple phases and are carefully designed studies used to test new treatments and evaluate their safety and efficacy in humans. Phase 1 trials involve 10-100 healthy participants and focus on safety, while Phase 2 trials involve 50-500 patient participants to explore effectiveness. Phase 3 trials involve 1000-3000 patients to confirm safety and efficacy. Phase 4 trials monitor treatments after approval when used by thousands of patients. In total, the clinical trial process from discovery to approval takes an average of 6-7 years and involves Phases 0-3 trials followed by Phase 4 post-marketing surveillance.
New drug development process
This document discusses the process of new drug development. It begins with basic research to understand disease pathways and identify potential drug targets. Promising compounds are identified through screening and optimized in preclinical testing, which evaluates safety and effectiveness in animals. If preclinical results are satisfactory, an Investigational New Drug Application is submitted to regulators to seek approval for clinical trials in humans. The drug development process is long and rigorous, aiming to bring safe and effective medications to market while meeting regulatory guidelines.
Drug discovery hit to lead
The document discusses the hit to lead (H2L) stage of drug discovery. In this stage, small molecule hits identified from high-throughput screening undergo limited optimization to identify lead compounds with improved binding affinity, selectivity, metabolic properties, and other qualities. The goal is to progress compounds from the micromolar binding range to nanomolar binding through synthetic analogs before advancing to the lead optimization stage. Key aspects of H2L include hit confirmation, expansion through synthetic analogs, and selection of lead series based on various criteria for further exploration.
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Stages of drug development
This document outlines the stages of drug development, beginning with drug discovery and ending with regulatory approval. It discusses the history of drug development from ancient times to modern pharmaceutical industry. The key stages are described as pre-clinical development involving non-human testing, clinical development involving human trials to test safety and efficacy, and regulatory approval. Drug discovery involves target identification, validation, lead discovery through screening, and lead optimization to improve desired properties. Recent advances like genomics, high-throughput screening, and bioinformatics have accelerated the drug development process.
Drug development process
The document discusses the process of new drug development, which involves several lengthy and costly stages. In preclinical testing, potential drug candidates are screened in animal and laboratory testing to evaluate toxicity, safety, and efficacy. If successful, compounds enter clinical trials involving 4 phases with human subjects to further assess safety and effectiveness. Only about 1-2% of initially investigated compounds ultimately result in an approved drug. The entire process from discovery to regulatory approval can take over 12 years and cost over $1 billion. Rigorous testing and regulatory standards aim to bring only safe and effective drugs to market.
Drug discovery and development
The document discusses the process for approval of a new drug from development through marketing. It takes 10-15 years on average and costs over $2.6 billion to get a new drug approved. Key steps include:
- Preclinical research to identify biological targets and compounds
- FDA approval to begin clinical trials in three phases involving thousands of subjects to test safety, efficacy, and dosing
- New Drug Application submission including all clinical trial data for FDA review and approval
- Post-marketing studies and generic approval after patents expire
1. Unit I - new drug discovery and development.
The document summarizes the stages of drug discovery and development. It begins with drug discovery, which involves understanding disease pathways and identifying drug targets. Lead compounds are then identified and optimized. Preclinical testing assesses safety. If successful, an investigational new drug application is filed and clinical trials proceed in four phases, from initial safety testing to large efficacy trials. If approved, post-marketing monitoring continues to assess long-term safety. The process aims to bring safe and effective therapies to patients while adhering to regulatory standards.
Regulation of herbal drugs in india
The document discusses the regulatory status of herbal drugs in India. It outlines that herbal drugs are regulated under the Drug and Cosmetic Act of 1940 and Rules of 1945. The Department of AYUSH is the regulatory authority that requires manufacturing and marketing licenses. It also discusses definitions, licensing procedures, good manufacturing practices, labeling requirements, and guidelines set by AYUSH.
Clinical studies
Clinical trials have multiple phases and are carefully designed studies used to test new treatments and evaluate their safety and efficacy in humans. Phase 1 trials involve 10-100 healthy participants and focus on safety, while Phase 2 trials involve 50-500 patient participants to explore effectiveness. Phase 3 trials involve 1000-3000 patients to confirm safety and efficacy. Phase 4 trials monitor treatments after approval when used by thousands of patients. In total, the clinical trial process from discovery to approval takes an average of 6-7 years and involves Phases 0-3 trials followed by Phase 4 post-marketing surveillance.
New drug development process
This document discusses the process of new drug development. It begins with basic research to understand disease pathways and identify potential drug targets. Promising compounds are identified through screening and optimized in preclinical testing, which evaluates safety and effectiveness in animals. If preclinical results are satisfactory, an Investigational New Drug Application is submitted to regulators to seek approval for clinical trials in humans. The drug development process is long and rigorous, aiming to bring safe and effective medications to market while meeting regulatory guidelines.
Drug discovery hit to lead
The document discusses the hit to lead (H2L) stage of drug discovery. In this stage, small molecule hits identified from high-throughput screening undergo limited optimization to identify lead compounds with improved binding affinity, selectivity, metabolic properties, and other qualities. The goal is to progress compounds from the micromolar binding range to nanomolar binding through synthetic analogs before advancing to the lead optimization stage. Key aspects of H2L include hit confirmation, expansion through synthetic analogs, and selection of lead series based on various criteria for further exploration.
Principles of drug discovery
The document summarizes the principles of drug discovery, including the following key points:
1) Drug discovery is a lengthy, expensive, and inefficient process involving target identification, screening, preclinical testing, and clinical trials that can take over 10 years from initial compound to approved drug.
2) Natural products, especially from plants, microbes, and marine organisms, have historically been an important source of leads for drug discovery due to their chemical diversity.
3) The modern drug discovery process involves high-throughput screening of large libraries of synthetic compounds and natural products to identify initial hits, which are then optimized in the hit-to-lead phase through medicinal chemistry and further testing.
Drug Designing
The document discusses the process of drug design and development. It begins by defining drugs and their targets at the molecular level. Historically, drugs came from plants and natural products, but now they can be designed rationally through understanding disease processes. The drug design process involves identifying a target, discovering leads, and optimizing candidates through computer modeling and testing before clinical trials. Modern techniques like molecular modeling, virtual screening, and computer-aided design have made drug discovery more efficient, but it remains a long, complex, and expensive process.
Drug discovery and development
Drug discovery and development is and always has been the most exciting part of clinical pharmacology. It is my attempt to compile the basic concepts from various books, articles and online journals. Feel free to comment.
Pre clinical studies
Pre-clinical screening involves testing potential new drugs in animal models before human trials to evaluate safety and efficacy. This includes pharmacological screening to determine mechanism of action and dose response, as well as toxicological testing to identify adverse effects and calculate safe starting doses for clinical trials. Studies progress from molecular and cellular assays to whole animal experiments. Acute and repeated dose toxicity tests are followed by sub-chronic and chronic studies to identify long-term effects. These pre-clinical studies aim to generate data required to deem a new compound safe enough for initial human testing.
Regulatory requirements for 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
Stages of drug discovery
The document outlines the key stages of drug discovery:
1. Target identification involves finding the specific biomolecule target of a drug.
2. Target validation helps evaluate the potential of a target through assays and screening to find initial hits.
3. Lead discovery uses screening methods like molecular modeling or combinational chemistry to identify initial compounds ("leads") that interact with the target.
4. Lead optimization chemically modifies the leads to improve efficacy, safety and other drug properties.
5. Pre-clinical safety involves animal testing, toxicity studies and formulation before clinical trials in humans.
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Drug discovery & development
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This document discusses definitions of patents, intellectual property rights, and traditional knowledge. It provides case studies of patents granted on turmeric and neem from India that were later revoked due to evidence that the traditional knowledge described in the patents had been previously known and used in India for many years. The document also discusses issues around biopiracy and bioprospecting as well as India's efforts through the Traditional Knowledge Digital Library to protect its traditional knowledge from misappropriation by improper patenting.
Drug regulatory authority
The document summarizes the drug regulatory system in India. The key points are:
- The Central Drugs Standard Control Organization (CDSCO) regulates pharmaceuticals and medical devices under the Ministry of Health and Family Welfare.
- CDSCO's functions include ensuring drug safety, efficacy and quality; approving new drugs and clinical trials.
- The Drugs Controller General of India heads CDSCO and is advised by the Drug Technical Advisory Board and Drugs Consultative Committee.
- State drug control administrations enforce drug regulation at the state level under the central Drugs and Cosmetics Act.
Drug discovery
The document provides an overview of the drug discovery and development process. It discusses the various stages involved, including target selection using genomics, proteomics and bioinformatics; lead discovery through synthesis, isolation and high-throughput screening; medicinal chemistry such as structure-activity relationships studies; in vitro and preclinical in vivo testing in animal models; and clinical trials in humans. The timeline for this process can span over 10-15 years from drug target identification to regulatory approval. Key techniques and approaches at each stage are also summarized.
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The study aimed to develop and evaluate a dental gel containing clove oil for treating periodontitis. Clove oil was characterized and a gel was formulated using carbopol 934 as the gelling agent, clove oil as the active ingredient, and other excipients. The gel was evaluated for various properties including antimicrobial activity, pH, spreadability, drug content, and extrudability. Preliminary results showed formulation F3 had suitable properties for treating periodontitis, with a zone of inhibition of 22.05±0.04 mm against test microbes. The authors concluded F3 showed good physicochemical properties and drug content compared to other formulations.
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This document summarizes the process of drug development from discovery through clinical trials and approval. It discusses the main goals and requirements of each phase of clinical trials: Phase I focuses on safety and dosing in healthy volunteers, Phase II evaluates efficacy and side effects in patients, Phase III tests efficacy versus existing treatments in hundreds to thousands of patients, and Phase IV monitors long-term safety and efficacy after approval and marketing. The overall process from discovery to approval takes 10-15 years and costs over $2 billion on average.
New drug discovery and development (Part - 1)
The document discusses the process of new drug discovery and development. It begins with definitions of key terms like drug, discovery phase, and development phase. It then describes the various stages of drug discovery and development, including target identification, lead identification, lead optimization, preclinical testing, clinical trials, and regulatory approval. The process takes 12-15 years and costs $900 million to $2 billion on average due to the need to test thousands of potential drug candidates. Characterization, formulation, preclinical safety testing, and clinical trials are described as important steps to develop a new drug for patients.
Gmp & glp
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Drug Development Process
The document outlines the multi-step process for biopharmaceutical drug development from discovery through marketing. It involves discovery, development, clinical testing, licensure, manufacturing, and marketing. Some key steps include identifying and validating drug targets, pre-clinical testing in animal models, conducting clinical trials in three phases with an increasing number of human subjects, obtaining regulatory approval from the FDA, large-scale commercial manufacturing under cGMP regulations, and marketing the approved drug. The entire process from discovery to approval typically takes 10-15 years.
Comparison of herbal pharmacopoeias
In this power points viewer will be able to know the meaning of Pharmacopoeia and its coposition. History behind the different pharmacopoeia and popular pharmacopoeia existing world wide in herbal medicines. List of different pharmacopoeias also has been included.
АГРОХИМИКИ СТОЯТ УСТОЙЧИВО
Российские агрохимические компании активно используют
портовые мощности для экспорта удобрений как в России, так и
в сопредельных государствах. Профицит мощностей позволяет
им наращивать экспорт за счет запуска новых производств и
внедрения прогрессивных технологий перевалки.
Виктор Цукер, по материалам доклада Александра Головизнина, директора
по направлению логистика и аналитика ООО «Морстройтехнология»
Clincial trials and types
The document provides an overview of the clinical trial process for new drugs. It discusses the various phases of clinical trials including preclinical testing in animals, Phase 0 microdosing studies, Phase I safety trials in healthy volunteers, Phase II small efficacy trials in patients, and Phase III large randomized controlled trials to confirm efficacy. The goal of clinical trials is to systematically evaluate a new drug's safety and efficacy in humans at various dose levels before it can be approved for marketing. Each phase addresses different objectives and increases in size and scope as the trials progress from preclinical to final approval stages.
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Principles of drug discovery
The document summarizes the principles of drug discovery, including the following key points:
1) Drug discovery is a lengthy, expensive, and inefficient process involving target identification, screening, preclinical testing, and clinical trials that can take over 10 years from initial compound to approved drug.
2) Natural products, especially from plants, microbes, and marine organisms, have historically been an important source of leads for drug discovery due to their chemical diversity.
3) The modern drug discovery process involves high-throughput screening of large libraries of synthetic compounds and natural products to identify initial hits, which are then optimized in the hit-to-lead phase through medicinal chemistry and further testing.
Drug Designing
The document discusses the process of drug design and development. It begins by defining drugs and their targets at the molecular level. Historically, drugs came from plants and natural products, but now they can be designed rationally through understanding disease processes. The drug design process involves identifying a target, discovering leads, and optimizing candidates through computer modeling and testing before clinical trials. Modern techniques like molecular modeling, virtual screening, and computer-aided design have made drug discovery more efficient, but it remains a long, complex, and expensive process.
Drug discovery and development
Drug discovery and development is and always has been the most exciting part of clinical pharmacology. It is my attempt to compile the basic concepts from various books, articles and online journals. Feel free to comment.
Pre clinical studies
Pre-clinical screening involves testing potential new drugs in animal models before human trials to evaluate safety and efficacy. This includes pharmacological screening to determine mechanism of action and dose response, as well as toxicological testing to identify adverse effects and calculate safe starting doses for clinical trials. Studies progress from molecular and cellular assays to whole animal experiments. Acute and repeated dose toxicity tests are followed by sub-chronic and chronic studies to identify long-term effects. These pre-clinical studies aim to generate data required to deem a new compound safe enough for initial human testing.
Regulatory requirements for 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
Stages of drug discovery
The document outlines the key stages of drug discovery:
1. Target identification involves finding the specific biomolecule target of a drug.
2. Target validation helps evaluate the potential of a target through assays and screening to find initial hits.
3. Lead discovery uses screening methods like molecular modeling or combinational chemistry to identify initial compounds ("leads") that interact with the target.
4. Lead optimization chemically modifies the leads to improve efficacy, safety and other drug properties.
5. Pre-clinical safety involves animal testing, toxicity studies and formulation before clinical trials in humans.
3206 law & ethics manik
Drug administration and pharmacy council of Bangladesh, their scope and functions.
Regulations and laws governing the practices of pharmacy (The pharmacy ordinance 1976). Control of drug advertisements, prices, patented and trade market medicine, proprietary medicine, schedules of drugs and poisons, regulation of cosmetics and poison control
Drug discovery & development
DRUG DISCOVERY & DEVELOPMENT PROCESS, it's a detail description about how drug is made available in market it's development and discovery of drug The Hole Study is given in This Topic.
Unit 4 definitions patent, ipr,fr,br,biopiracy & neem haldi
This document discusses definitions of patents, intellectual property rights, and traditional knowledge. It provides case studies of patents granted on turmeric and neem from India that were later revoked due to evidence that the traditional knowledge described in the patents had been previously known and used in India for many years. The document also discusses issues around biopiracy and bioprospecting as well as India's efforts through the Traditional Knowledge Digital Library to protect its traditional knowledge from misappropriation by improper patenting.
Drug regulatory authority
The document summarizes the drug regulatory system in India. The key points are:
- The Central Drugs Standard Control Organization (CDSCO) regulates pharmaceuticals and medical devices under the Ministry of Health and Family Welfare.
- CDSCO's functions include ensuring drug safety, efficacy and quality; approving new drugs and clinical trials.
- The Drugs Controller General of India heads CDSCO and is advised by the Drug Technical Advisory Board and Drugs Consultative Committee.
- State drug control administrations enforce drug regulation at the state level under the central Drugs and Cosmetics Act.
Drug discovery
The document provides an overview of the drug discovery and development process. It discusses the various stages involved, including target selection using genomics, proteomics and bioinformatics; lead discovery through synthesis, isolation and high-throughput screening; medicinal chemistry such as structure-activity relationships studies; in vitro and preclinical in vivo testing in animal models; and clinical trials in humans. The timeline for this process can span over 10-15 years from drug target identification to regulatory approval. Key techniques and approaches at each stage are also summarized.
Regulatory Affairs Profession
The presentation is about: Drug Regulatory Affairs as a profession, Scope & Responsibilities in life cycle management of a drug and role of RA in the drug approval process.
B.pharm project 2015 16 ppt
The study aimed to develop and evaluate a dental gel containing clove oil for treating periodontitis. Clove oil was characterized and a gel was formulated using carbopol 934 as the gelling agent, clove oil as the active ingredient, and other excipients. The gel was evaluated for various properties including antimicrobial activity, pH, spreadability, drug content, and extrudability. Preliminary results showed formulation F3 had suitable properties for treating periodontitis, with a zone of inhibition of 22.05±0.04 mm against test microbes. The authors concluded F3 showed good physicochemical properties and drug content compared to other formulations.
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Career in pharmacy
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A well-rounded career
A vital part of the health care team
Outstanding career opportunities
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A trusted profession
Drug development process and clinical trial for UGs
This document summarizes the process of drug development from discovery through clinical trials and approval. It discusses the main goals and requirements of each phase of clinical trials: Phase I focuses on safety and dosing in healthy volunteers, Phase II evaluates efficacy and side effects in patients, Phase III tests efficacy versus existing treatments in hundreds to thousands of patients, and Phase IV monitors long-term safety and efficacy after approval and marketing. The overall process from discovery to approval takes 10-15 years and costs over $2 billion on average.
New drug discovery and development (Part - 1)
The document discusses the process of new drug discovery and development. It begins with definitions of key terms like drug, discovery phase, and development phase. It then describes the various stages of drug discovery and development, including target identification, lead identification, lead optimization, preclinical testing, clinical trials, and regulatory approval. The process takes 12-15 years and costs $900 million to $2 billion on average due to the need to test thousands of potential drug candidates. Characterization, formulation, preclinical safety testing, and clinical trials are described as important steps to develop a new drug for patients.
Gmp & glp
Good Manufacturing Practices (GMP) ensure consistency in the quality of pharmaceutical products. GMP guidelines cover quality control, documentation, personnel qualifications, premises, equipment, materials, production, and quality assurance. Adherence to GMP is important for pharmaceutical export and most regulatory agencies only approve imports of medicines made under GMP standards. Key aspects of GMP include qualification and validation of equipment and processes, complaint handling, recalls, and self-inspections. GMP guidelines also exist specifically for herbal medicines to ensure quality, safety and efficacy of these complex biological products.
Drug Development Process
The document outlines the multi-step process for biopharmaceutical drug development from discovery through marketing. It involves discovery, development, clinical testing, licensure, manufacturing, and marketing. Some key steps include identifying and validating drug targets, pre-clinical testing in animal models, conducting clinical trials in three phases with an increasing number of human subjects, obtaining regulatory approval from the FDA, large-scale commercial manufacturing under cGMP regulations, and marketing the approved drug. The entire process from discovery to approval typically takes 10-15 years.
Comparison of herbal pharmacopoeias
In this power points viewer will be able to know the meaning of Pharmacopoeia and its coposition. History behind the different pharmacopoeia and popular pharmacopoeia existing world wide in herbal medicines. List of different pharmacopoeias also has been included.
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АГРОХИМИКИ СТОЯТ УСТОЙЧИВО
Российские агрохимические компании активно используют
портовые мощности для экспорта удобрений как в России, так и
в сопредельных государствах. Профицит мощностей позволяет
им наращивать экспорт за счет запуска новых производств и
внедрения прогрессивных технологий перевалки.
Виктор Цукер, по материалам доклада Александра Головизнина, директора
по направлению логистика и аналитика ООО «Морстройтехнология»
Clincial trials and types
The document provides an overview of the clinical trial process for new drugs. It discusses the various phases of clinical trials including preclinical testing in animals, Phase 0 microdosing studies, Phase I safety trials in healthy volunteers, Phase II small efficacy trials in patients, and Phase III large randomized controlled trials to confirm efficacy. The goal of clinical trials is to systematically evaluate a new drug's safety and efficacy in humans at various dose levels before it can be approved for marketing. Each phase addresses different objectives and increases in size and scope as the trials progress from preclinical to final approval stages.
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Well-trained clinical research professionals are in high demand. The tremendous increase in medical technology and information in the last decade has resulted in an explosion of potential new drugs, devices and biologics that must be tested before being released for use by the public. The profession is constantly challenged to improve and streamline the clinical research programs in order to shorten the development timelines and control the cost for new product development
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Detailed Lesson Plan
This lesson plan provides an overview of teaching a lesson on the properties of water in science class. The objectives are for students to understand the polarity and hydrogen bonding of water molecules and how this affects water's properties. The lesson includes presentations, discussions, and hands-on activities like observing how detergent affects the surface tension of water and using chromatography paper to demonstrate capillary action. Students make predictions and observations. The lesson aims to explain why water and oil don't mix and how substances dissolve based on their hydrophilic/hydrophobic properties.
Clinical Trial Phases
Clinical trials involve several phases:
- Phase I trials involve small groups of healthy volunteers or patients and aim to determine the safety and tolerability of a new drug.
- Phase II trials involve larger groups of patients and aim to determine efficacy and further evaluate safety. These trials provide preliminary data on effectiveness.
- Phase III trials involve even more patients and aim to confirm effectiveness, monitor side effects, and compare the new treatment to standard treatment. These trials provide the primary data to support effectiveness. Regulatory approval is based on positive Phase III results showing safety and effectiveness.
Detailed Lesson Plan (ENGLISH, MATH, SCIENCE, FILIPINO)
Thanks everybody! The lesson plans presented were actually outdated and can still be improved. I was also a college student when I did these. There were minor errors but the important thing is, the structure and flow of activities (for an hour-long class) are included here. I appreciate all of your comments! Please like my fan page on facebook search for JUNNIE SALUD.
*The detailed LP for English is from Ms. Juliana Patricia Tenzasas. I just revised it a little.
For questions about education-related matters, you can directly email me at mr_junniesalud@yahoo.com
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Detailed Lesson Plan (ENGLISH, MATH, SCIENCE, FILIPINO)
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Drug discovery and development is a long process that begins with identifying disease targets and progresses through rigorous laboratory and clinical testing. Scientists and researchers work to find potential drug candidates, or "hits", that can interact with disease targets through methods like high-throughput screening. These hits then undergo optimization and testing in vitro and in vivo before entering clinical trials with human subjects. If clinical trials show a drug is safe and effective, regulatory agencies may approve it for marketing and ongoing monitoring. The goal is to collaborate across disciplines to develop innovative and safe treatments for medical conditions.
Clinical Trial
New drug development involves a series of pre-clinical and clinical trials. In pre-clinical trials, new chemical compounds are screened in vitro and tested in animal models to assess pharmacology, toxicity, and effectiveness. If a compound shows promise, it enters clinical trials with humans. Clinical trials have four phases - Phase I tests safety in a small group, Phase II explores efficacy in a larger group, Phase III tests efficacy in a larger patient population, and Phase IV monitors long-term safety and efficacy after market approval. The drug development process aims to establish that a new drug is safe and effective for its intended use through rigorous multi-stage testing.
The stages of Drug Discovery and Development process
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug
Stages of drug development by Dr Joseph Oyepata Simeon (Ph.D)
The document outlines the stages of drug development from discovery through clinical trials and FDA approval. It discusses 4 main stages: 1) Discovery and preclinical research involving animal testing, 2) Clinical research consisting of 4 phases starting with small safety trials and increasing in size, 3) Filing an Investigational New Drug Application with the FDA to begin clinical trials, and 4) Final FDA review and potential approval or denial to market the drug. Only about 25-30% of drugs make it through the entire process, which can take 10-15 years and costs over $2 billion on average.
Drug Development Process
The document outlines the multi-step process of drug development from pre-discovery through clinical trials and regulatory approval. It begins with basic research to understand disease mechanisms, followed by drug discovery and pre-clinical testing in animals. If pre-clinical data is promising, an IND application is submitted for human trials. Phase 1-3 clinical trials progressively involve more patients to test safety, efficacy, and long-term effects. With positive results, an NDA is submitted for regulatory review. If approved, phase 4 trials monitor drug use in broader populations. The process takes 10-15 years and over $800 million on average to bring a new drug to market.
Drug development process
The document summarizes the stages of drug development from discovery through clinical trials and regulatory approval. It describes 10 main stages: 1) discovery and development, 2) preclinical research, 3) investigational new drug application, 4) clinical research including 3 phases of trials, 5) FDA review and approval, and 6) post-market safety monitoring. Preclinical research involves testing for safety and efficacy in animal and lab models. If promising, the drug enters clinical trials with humans starting with small Phase 1 safety studies, then Phase 2 dosing studies, and larger Phase 3 trials to confirm efficacy before the FDA reviews the final application for approval. The overall process takes around 10-15 years from discovery to patients.
Drug discovery and development process
this slide share will provide information about drug discovery and development.in this, how the drug is discovered and what type of procedures and instructions followed during discovery and development of a new drug and also give limitations of drug discovery and development process.
Clinical trial
Clinical trials involve testing potential new drugs and medical devices on humans in a series of phases to evaluate safety and efficacy before regulatory approval. The process takes an average of 10-12 years and begins with extensive preclinical research using animal and lab testing. If successful, testing advances to 4 phases of human subjects, starting with small healthy volunteer groups to test safety, then increasing sizes to study effectiveness in patients. After each phase, data is submitted to regulators before progressing further through the approval process. The goal is to generate evidence about a treatment's risks and benefits to support decisions about its use.
what are Clinical trial?
Clinical trials involve testing potential new drugs and medical devices on humans in a series of phases to evaluate safety and efficacy before regulatory approval. The process takes an average of 10-12 years and begins with extensive preclinical research using animal and lab testing. If successful, testing advances to 4 phases of human subjects, starting with small healthy volunteer groups to test safety, then increasing sizes to study effectiveness in patients. After each phase, data is submitted to regulators before progressing further. The goal is to understand effects on humans and identify side effects or issues requiring more study before a drug can be approved for widespread consumer use.
Clinical trials
Clinical trials are research studies that test new medical treatments in people. Each trial aims to answer scientific questions and find better ways to prevent, diagnose, or treat disease. Trials follow a strict protocol and require approval from an institutional review board to ensure ethical treatment of participants. Clinical trials progress through several phases. Phase 0 and 1 trials involve small numbers of participants and aim to determine safety and how the body responds. Phase 2 trials provide more data on side effects and effective dosing while phase 3 trials compare new treatments to standard treatments with larger numbers of participants. Phase 4 trials study long term safety and effectiveness once a treatment has been approved.
HISTORY, CONCEPT AND ITS IMPORTANCE IN DRUG DEVELOPMENT.pptx
Drug development is a long, expensive, and high-risk process that takes an average of 10-15 years. It involves preclinical research in animals and humans to test safety and efficacy. Clinical trials in humans have 4 phases - Phase I tests safety in small groups, Phase II explores efficacy in small patient groups, Phase III tests in large patient groups to confirm efficacy and safety for approval, and Phase IV occurs after approval to monitor long-term effects. Only about 1 in 10 drugs that enter clinical trials will ultimately receive regulatory approval due to the high costs and failure rates of drug development. Rigorous testing and regulatory review are required to bring a new drug to market globally.
Explanation of the Four Phases of Clinical Trials
Before clinical trials, tests and treatments are assessed in preclinical research. There is a need to carry all four phases of clinical trials
Clinical Trials
Pre-clinical and clinical trials are processes used to test drugs and medical devices for safety and efficacy before human use. Pre-clinical trials involve basic research and testing in animals. If promising, an Investigational New Drug application is filed with the FDA to begin clinical trials with humans. Clinical trials are conducted in phases, starting with small safety trials and progressing to large efficacy trials. If successful, final approval is sought from the FDA through a New Drug Application. The entire drug development process from basic research to approval typically takes 12-15 years and costs $100-800 million per drug.
Drug Development and Clinical Studies
The document discusses the process of drug development from discovery through clinical trials and regulatory approval. It begins with an overview of the iterative process involving biology, animal testing, and medicinal chemistry. It then outlines the typical 5 steps in drug development according to the FDA: discovery/screening, pre-clinical research including in vitro and in vivo testing, clinical research consisting of Phase I-III trials, FDA review, and post-marketing monitoring. The document provides details on each stage of development including pre-clinical and clinical research requirements and processes.
Development of drug
The document discusses the complex process of drug development from initial discovery through clinical trials and regulatory approval. It involves several key stages: drug discovery, preclinical testing for safety and efficacy, submission of an investigational new drug application to the FDA, followed by four phases of clinical trials on humans to test for safety, efficacy, side effects and effectiveness. If successful, the drug can then be approved for marketing. However, it continues to be monitored post-approval for side effects or issues that could lead to withdrawal from the market. The entire process takes 5-10 years and billions of dollars.
Clinical trials
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Overview of Pharmacovigilance by Yash Dhikale | Zumbar Pote | Santosh Ghuge |...
Clinical research is an essential component of medical advancement, focusing on understanding health and disease to enhance healthcare practices. This exploration encompasses clinical trials, classified into interventional studies and observational studies. Interventional studies, or clinical trials, involve assigning participants interventions to evaluate their effects on health outcomes. These interventions can range from drugs to surgical procedures or preventive care. Clinical trials progress through four phases, ensuring safety and efficacy before widespread implementation. The International Clinical Trials Registry Platform ICTRP , a global initiative by WHO, facilitates comprehensive and accessible information on human clinical trials. ICTRP strives to enhance data accuracy, raise awareness about trial registration, and promote data utilization. This collaborative effort fosters transparency, benefiting not only researchers but also patients, families, and the broader healthcare community. Yash Dhikale | Zumbar Pote | Santosh Ghuge | Shital B. Thakre | Dipali S. Shegar "Overview of Pharmacovigilance" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63464.pdf Paper Url: https://www.ijtsrd.com/pharmacy/other/63464/overview-of-pharmacovigilance/yash-dhikale
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The stages of Drug Discovery and Development process
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Slections
At an average temperature of 10°C, the optimum fur length for survival is 15mm, with individuals distributed around this length. If the temperature drops to 5°C, individuals with longer fur are better insulated and more likely to survive and reproduce, passing on genes for longer fur. Over generations, the mean fur length of the population increases as longer-furred individuals survive at a higher rate than shorter-furred individuals, until the optimum length is reached again.
Lab safety[1]
Students should queue quietly outside the classroom until instructed to enter, store bags under desks, and follow safety procedures like wearing glasses and not touching equipment without permission during science experiments to prevent injuries from flammable or breakable materials.
The Carbon Cycle
Carbon is constantly cycled around the biosphere through processes like combustion, respiration, and being stored in marine organisms and limestone rocks. Combustion and respiration both release carbon dioxide gas. While both animals and plants respire, only respiration releases carbon dioxide. Scientists think increased carbon dioxide in the atmosphere from human activities will cause global warming.
Decay And Decomposition
Decomposers like mushrooms, worms and bugs play an important role in decay and decomposition by breaking down dead organisms and converting them into soil. For decay to occur, certain conditions need to be present including warmth, moisture and oxygen. Without decomposers, dead organisms would accumulate and the world would be covered in remains rather than recycled into dirt.
Energy Losses
This document compares factory farming to free range farming and discusses their advantages and disadvantages. Factory farming allows for higher productivity and profitability due to less movement and stress on animals, lower disease risk, and independence from climate factors, but requires more feeding costs and labor. Free range farming is less labor intensive and stressful for animals, but is more expensive, animals are vulnerable to climate and disease spread, and has a worse public reputation.
Energy Flow
The document discusses how energy from the sun is incorporated into biomass through producers, consumers, and decomposers in a food chain or web. It defines producers as organisms like plants that can produce their own food, consumers as organisms that obtain energy by eating other organisms, decomposers as organisms that break down waste and dead materials, and provides examples of each. It also notes that food pyramids show the transfer of biomass from one trophic level to another.
Energy Flows – Pyramids Of Biomass
This lesson plan aims to explain how solar radiation provides energy for living organisms and how this energy is incorporated into biomass. Students will recall simple food chains and define biomass. Then, using an online simulation, students will learn how food chains can be represented as pyramids of biomass and numbers. They will draw examples in their books and complete a worksheet. In the plenary, key concepts will be reviewed using pages from the New Edition Biology textbook.
Energy In Food Production
This document discusses improving the efficiency of food production by comparing free-range and factory farming methods. Free-range farming has advantages like less stress and disease in animals, better tasting meat, lower costs, and higher productivity. However, it also has disadvantages like being more labor-intensive, expensive to feed animals, and animals are more susceptible to climate. Factory farming has less disadvantages but is also less humane.
B3a13plant Mineral Deficiencies
This document summarizes common mineral deficiencies in plants. It identifies that nitrogen deficiency causes yellow leaves and stunted growth, potassium deficiency causes yellow leaves that die, and magnesium deficiency causes yellow leaves with green veins and brown spots. Phosphorus deficiency reduces all aspects of plant growth. The document also states that plants absorb mineral ions from the soil through their roots to enable general growth, and mineral deficiencies result in stunted growth or yellow leaves.
Hydroponic Farming
Hydroponic farming is an efficient way for farmers and growers to produce crops. It allows them to understand the most economic way of growing plants without soil by using mineral nutrient solutions in a water solvent. Hydroponics can help maximize crop yields while using fewer resources.
Light Intensity And Photosynthesis
The lesson plan outlines an experiment to investigate how light intensity affects the rate of photosynthesis. Students will measure the rate of bubble production in Elodea over a range of distances from a lamp to determine the relationship between light intensity and photosynthesis. In the first lesson, students will set up the experiment and collect initial data. The second lesson will involve collecting additional data and graphing the results to show how the rate of photosynthesis changes with light intensity. The goal is for students to understand that light energy drives photosynthesis and more intense light results in a higher rate.
Starch
Starch, glycogen, and cellulose are polysaccharides that serve important functions in organisms. Starch is made of glucose monomers linked by glycosidic bonds and forms coils that allow it to be compactly stored in plants. Glycogen in animals is similarly structured but more branched, allowing easier breakdown. Cellulose is made of beta-glucose monomers rather than alpha-glucose, causing its chains to form parallel and rigid, providing structure and support in plant cell walls.
Factors Which Affect Photosynthesis
Photosynthesis can be limited by several factors including light intensity, temperature, and carbon dioxide levels. As light intensity increases, the rate of photosynthesis also increases until it reaches a maximum level where another factor becomes limiting. Anything in short supply that is needed for photosynthesis, such as light, heat, or carbon dioxide, can act as a limiting factor to slow the rate of photosynthesis.
The Variety Of Life Continued
There are different types of haemoglobin that take up and release oxygen under different conditions. Haemoglobin with high affinity takes up oxygen easily but releases less readily, while low affinity haemoglobin is not as easy to take up oxygen but releases it more readily. The affinity is correlated to environmental factors like oxygen levels and the organism's metabolic rate. Differences in affinity are caused by variations in the amino acid sequence, which change the shape of haemoglobin. Carbon dioxide reduces the affinity of haemoglobin for oxygen through the Bohr effect, making it release oxygen more readily in tissues with high carbon dioxide levels like respiring muscles.
Cell Images
This document discusses how cells allow for the movement of substances and how understanding cells helps explain biological functions. It lists different biological materials like red blood cells, human hair, leaf stomata, pollen, and skin as examples of substances that move or are moved via cells. The list also includes non-biological items like toilet paper, matches, cotton, and diamonds for comparison.
Diffusion
Diffusion is the spreading of particles in a solution from an area of higher concentration to one of lower concentration, resulting in an even distribution of particles. The rate of diffusion is affected by concentration difference, temperature, and the shape of the particles.
Osmosis – A Special Type Of Diffusion
The document describes an experiment on osmosis using potato slices in solutions with different sucrose concentrations. Potato slices placed in distilled water gained mass, those in the 1.0M sucrose solution lost mass, and those in the 0.3M solution showed no mass change, indicating osmosis. Osmosis is defined as the passive movement of water through a semi-permeable membrane from a region of lower solute concentration to higher concentration until equilibrium is reached. This movement provides support to plant cells by increasing pressure inside the cell.
Jc Aqa Adds 006 B21 2 Prs Plantcells
The document describes the key characteristics and functions of several types of specialized plant and animal cells, including palisade cells, root hair cells, guard cells, xylem cells, epidermal cells, fat cells, neurons, red blood cells, muscle cells, sperm cells, gland cells, and egg cells. Each cell type is specialized to perform a particular role through adaptations like surface area, organelle content, shape, and secretory abilities.
Cells
This document provides instructions for making slides of onion cells and cheek cells to view under a microscope. The steps are to peel a thin layer of onion, scrape the area with a cotton bud and place it on a slide, then add iodine. For cheek cells, scrape the inside of the cheek with a cotton bud, place it on a separate slide, and add methylene blue. Both slides should then have excess liquid blotted off and a cover slip lowered onto the sample.
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Drugtesting
- 1. Trialling drugs Lesson objectives To describe how new medicines are developed and the possible consequences if drugs are not tested properly. List some medical drugs. How long do you think it takes to get a drug to market and what does it cost?
- 2. Answer 10-12 years and US$500 million
- 3. Synthetic chemicals? First tests in laboratory Animal testing Phase I: Testing on students! Phase II: Testing on patients Phase III: Final tests and licensing Which diseases to treat? Traditional remedies? Drug Development and Testing
- 4. Developing new drugs – Stage A Researchers target a disease and develop ideas for treatments.
- 5. Developing new drugs – Stage B The search for possible drugs includes the computer design of molecules and screening hundreds of thousands of chemicals.
- 6. Developing new drugs – Stage C Possible drugs are made (synthesised) in the lab.
- 7. Developing new drugs – Stage D In vitro screening – the potential medicines are tested on cell cultures, tissue cultures and isolated whole organs in the lab. Many chemicals fail at this stage because they don’t work or are toxic.
- 8. Developing new drugs – Stage E Animal testing – the small number of chemicals which make it this far are now tested on animals. This finds out more about how they work in a whole living organism. It tells us what dose is needed and sees if they cause any side-effects.
- 9. Developing new drugs – Stage F Animal testing continues, looking at the effect of longer-term use of the medicine.
- 10. Developing new drugs – Stage G Clinical testing on humans begins with phase 1 on a small number of healthy volunteers. This looks at the safety of the medicine in people.
- 11. Developing new drugs – Stage H Human phase 2 trials run with a small number of the patients suffering from the target disease. This is where scientists can really begin to see if the drug will be safe, effective and if it works .
- 12. Developing new drugs – Stage I Human phase 3 trials continue with a larger number of patients.
- 13. Developing new drugs – Stage J When the medicine has passed all the tests set down in law, it will be granted a licence. Now your doctor can use the new medicine to treat your illness.
- 14. Developing new drugs – Stage K Once the medicine is in use, phase 4 trials continue. The medicine will be monitored for as long as patients use it . This makes sure it works and is as safe as possible.
- 15. Which diseases to treat? Doctors, politicians, drug company executives, members of the public and scientists all have an opinion. At some point money will be made available for the research into a disease cure to begin.
- 16. Traditional remedies? Where to start? Sometimes researchers will look at ‘traditional remedies’ to see if there is anything to learn. Plants, animals, bacteria and fungi have all been used as sources for new medicines.
- 18. Phase I Human trials: testing on volunteers The (very few) chemicals that pass the animal testing stage move on to the first human tests. These are done on healthy people – often students who get paid a small amount of money for volunteering. This stage checks the safety of the drug and looks for side effects. Animal tests continue, looking for any long term effects.
- 19. Phase II: Testing on patients The first ill people to get the drug are the Phase II volunteers. This is where scientists can really begin to see if the drug will be safe and effective.
- 20. Phase III: Final tests and licensing If all goes well with phase II the trials move to phase III. Many more people are given the new drug. Some of the people in the phase III trial will be given dummy treatment so that doctors can compare the effect of the drug with already available medicines or nothing at all. By the end of a successful phase III the drug company submits its research to government bodies to ask for a licence to sell the drug.
- 21. Even once a medicine has been licensed for use it is still watched carefully for unexpected problems. These phase IV trials, where doctors report on any side effects suffered by their patients, continue as long as the medicine is used. Phase IV trials can involve hundreds of thousands of people. Sometimes the trials throw up unexpected problems - medicines can even be withdrawn from use because serious problems appear! A drug company may decide to develop a new drug to replace the original one because it has fewer side effects. The whole process begins again! Peninsula Medical School