Session 2 part 3
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The document discusses guidelines for various types of toxicology studies required for drug development including genetic toxicity studies, safety pharmacology studies, general toxicology studies, and toxicokinetics studies. Genetic toxicity studies evaluate mutagenicity and chromosomal damage in vitro and in vivo. Safety pharmacology involves in vitro and in vivo studies of effects on the brain, lungs, and heart. General toxicology includes studies in two species, usually rats and non-rodents, over various durations from acute to chronic. Toxicokinetics verifies exposure levels in dosed groups. A minimum data package is required to support an Investigational New Drug application.
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Fundamentals Of Genetic Toxicology In The Pharmaceutical Industry Sept 2010
Historical and current perspectives on genetic toxicology, with commentary and slides on assay predictivity and shortcomings, regulatory guidance, and high-throughput screens to enhance preclinical drug safety.
Pharmacogenetics devang
This document discusses pharmacogenetics and how genetic differences can influence drug response. It introduces key concepts like the human genome project, pharmacogenomic effects on drug metabolism and transport, and how genetic testing can help determine who will respond to or be toxic to specific drugs. The goal is to develop personalized medicine where a person's genetic makeup is used to optimize drug selection and dosing for safety and effectiveness.
In vitro-in-vivo correlation
This document discusses in-vitro-in-vivo correlations (IVIVC) for oral controlled release products. It covers the relevance and definition of IVIVC, levels of IVIVC, methods for generating in-vitro and in-vivo release profiles, predictability of IVIVC models, and issues related to IVIVC modeling. The key points are that biorelevant dissolution testing can predict in vivo absorption if IVIVC is established, several mathematical models can be used to estimate in vivo release profiles, and IVIVC is useful for quality control but has practical and modeling challenges that must be addressed.
Tier 1, 2 and 3 Capital based on the Basel II accord
The document discusses the three tiers of capital requirements under the Basel II accord:
Tier 1 capital consists of core equity and reserves, and must comprise at least 50% of a bank's total capital base. Tier 2, or supplementary capital, includes undisclosed reserves, revaluation reserves, general provisions, and various subordinated debt instruments. Tier 3 capital is short-term subordinated debt limited to 250% of Tier 1 capital required to support market risks, with a minimum of 281⁄2% of market risks supported by Tier 1 capital.
Dissolution and In Vitro In Vivo Correlation (IVIVC)
This presentation gives a bird's eye view on Dissolution in context with IVIVC. It discusses various levels of Correlations currently in practice. IVIVC are explained in light of biowaivers It also touches upon IVIVR, IVIVM etc.
cell injury
This document discusses cellular injury and cell death. It begins by introducing the hierarchical structure of the human body from cells to organs to systems. It then describes the different types of tissues and cellular adaptations and injuries. The main types of cellular injury discussed are reversible and irreversible injuries. Reversible injuries include changes like swelling while irreversible injuries involve cell death through necrosis or apoptosis. The document closes by defining different patterns of necrosis like coagulation, liquefactive, and caseous necrosis.
Pharmacogenetics
This document provides an overview of pharmacogenetics and discusses:
1. Pharmacogenetics is the study of how genetic factors influence individual responses to drugs. It considers both environmental and genetic factors that impact drug metabolism and effects.
2. Key concepts include how genetic polymorphisms affect drug metabolizing enzymes and transporters, leading to variability in drug efficacy and risk of adverse reactions between individuals.
3. The field has progressed from early discoveries of genetic disorders affecting drug response to now understanding the effects of common gene variants, with the goal of personalized medicine to optimize drug therapy for each patient.
genome mapping
Genome mapping involves assigning DNA fragments to chromosomes and providing a guide for sequencing. There are two main categories of mapping - genetic mapping which uses genetic techniques like cross-breeding experiments to construct maps showing gene positions, and physical mapping which examines DNA molecules directly to map sequence features. Genome maps have improved over time from early genetic maps using visible traits as markers, to newer techniques like restriction mapping and sequencing tagged sites that provide higher resolution maps needed for genome projects.
Recombinant DNA technology
This document discusses recombinant DNA technology and DNA cloning. It describes several methods for cloning DNA, including plasmid cloning, bacteriophage lambda cloning, and yeast artificial chromosome cloning. The key steps in DNA cloning are fragmentation of DNA, ligation of DNA fragments, transfection into host cells, and screening of cells. Recombinant DNA libraries, such as genomic libraries and cDNA libraries, allow storage and identification of cloned DNA fragments.
Immunomodulators(VK)
This document discusses immunomodulators, which are substances that affect the immune system by either suppressing or stimulating it. It describes two main types: immunosuppressants, which decrease immune response, and immunostimulants, which increase immune response. Common immunosuppressants discussed include cyclosporine, tacrolimus, azathioprine, methotrexate, mycophenolate mofetil, glucocorticoids, and antibodies. These work by interfering with cytokine production, lymphocyte proliferation, antibody synthesis, and other immune mechanisms. Immunosuppressants are used for organ transplantation and autoimmune diseases but can have side effects like infection, cancer, and nephrotoxicity
Genome Mapping
Genetic mapping uses genetic techniques like cross-breeding experiments to construct maps showing gene positions. Physical mapping uses molecular techniques to examine DNA directly and construct maps showing sequence features. Different DNA markers like RFLPs, SSLPs, SNPs can be used for genetic mapping. Techniques for physical mapping include restriction mapping, fluorescent in situ hybridization (FISH), and sequence tagged site (STS) mapping. Integrating genetic and physical maps provides high resolution mapping needed for genome sequencing.
Pharmacogenomics
Pharmacogenomics is a new trending branch which has created enormous hopes in improving diagnostic methods, treatment outcomes and preventing adverse events and therapeutic failures. In this ppt basics of pharmacogenomics and pharmacogenetics has been discussed in simplest possible way along with two case studies. Clinical applications of pharmacogenomics has also been discussed in brief.
TRANSPOSABLE ELEMENTS
This document discusses transposable elements (TEs), which are segments of DNA that can move within genomes. It covers their discovery by Barbara McClintock in corn in the 1940s. TEs are classified into different types based on their structure and mechanism of movement. The document also examines the mechanisms of transposition, mutagenic effects, regulation, and presence of TEs across bacteria, fungi, and eukaryotes like humans. TEs make up a large fraction of genomes and contribute to genetic variation and disease.
Recombinant dna technology
Recombinant DNA technology involves intentionally modifying organisms' genomes for practical purposes such as eliminating undesirable traits, combining beneficial traits from different organisms, or creating organisms that synthesize useful products. The key steps involve isolating a gene of interest, inserting it into a plasmid, introducing the plasmid into bacteria, and harvesting copies of the gene or its protein products. Common tools used include mutagens, reverse transcriptase to synthesize cDNA, synthetic nucleic acids, restriction enzymes to cut DNA at specific sites, vectors to deliver genes into cells, and gene libraries containing collections of cloned genes.
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In vitro data and in silico models for predictive toxicology
In vitro data and in silico models for predictive toxicology
Fundamentals Of Genetic Toxicology In The Pharmaceutical Industry Sept 2010
Fundamentals Of Genetic Toxicology In The Pharmaceutical Industry Sept 2010
Tier 1, 2 and 3 Capital based on the Basel II accord
Tier 1, 2 and 3 Capital based on the Basel II accord
Dissolution and In Vitro In Vivo Correlation (IVIVC)
Dissolution and In Vitro In Vivo Correlation (IVIVC)
Similar to Session 2 part 3
chronic toxicity studies
Chronic toxicity studies are conducted over a long period of time, usually 12 months, to determine the effects of repeated exposure to a substance. They are guided by organizations like OECD and involve observations of animals dosed with the substance over their lifetime. Key steps include dosing animals at different levels and observing them for signs of toxicity, conducting clinical pathology tests, and examining organs at necropsy. The results are reported and discuss dose-response relationships and any target organs affected to understand the substance's chronic toxicity.
GENERAL GUIDELINES FOR TOXICOPATHOLOGY STUDY
The nonclinical safety study recommendations for the marketing approval
of a pharmaceutical usually include single and repeated dose toxicity
studies, reproduction toxicity studies, genotoxicity studies, local tolerance
studies, and for drugs that have special cause for concern or are intended
for a long duration of use, an assessment of carcinogenic potential. Other
nonclinical studies include pharmacology studies for safety assessment
(safety pharmacology) and pharmacokinetic (absorption, distribution,
metabolism, and excretion (ADME)) studies. These types of studies and
their relation to the conduct of human clinical trials are presented in this
guidance.
Toxicological Approach to Drug Discovery
This document outlines the toxicological approach to drug development. It discusses the importance of conducting various toxicity studies at different stages of drug development to ensure safety. These include single dose, repeated dose, fertility, reproductive, developmental and genotoxicity studies in animals. It describes the typical safety program involving staged approach and discusses factors to consider in designing toxicity studies. The goal is to obtain sufficient non-clinical safety data to support clinical trials and assess safety for human use.
Toxicity studies
This presentation is about toxic effects of different drugs and also how to reduce to its effect.
I hope you will like it,,
Don't forget to remember in your precious Dua,,
Toxicokinetic evaluation in preclinical studies.pptx
1. Toxicokinetics is the study of how toxic substances are affected by the body in terms of absorption, distribution, metabolism, and excretion. It applies pharmacokinetic principles to doses used in toxicology testing.
2. The primary objective of toxicokinetic evaluation in preclinical studies is to describe systemic exposure levels in animals and relate this to toxicity findings to assess clinical safety. Secondary objectives include supporting species and dose selection for toxicity studies.
3. Toxicokinetic data is collected in various required preclinical safety studies, including repeat-dose toxicity studies, reproduction toxicity studies, and genotoxicity studies, to interpret results and demonstrate drug exposure.
Oecd for chronic toxicity
Initial considerations for the study design include information on the test chemical's identity, properties, and results from previous toxicity tests. The guideline describes conducting a chronic toxicity study in rodents for 12 months, with the potential for interim kills and satellite groups. Key steps include dosing animals daily, observing them for signs of toxicity, and conducting clinical pathology, including hematology, clinical biochemistry, and urinalysis at various times. At the end, a full gross necropsy is performed and tissues are examined microscopically. Results are reported individually and summarized, including survival, body weights, food consumption, toxic responses, organ weights, and histopathological findings.
safety-and-toxicology-lecture-notes-18.pdf
This document provides an overview of safety and toxicology testing for drug development. It discusses key concepts like toxicity, hazard, risk and regulatory guidance. A variety of preclinical safety studies are described that are required to support clinical trials, including general toxicology studies in two species, assessments of genotoxicity, carcinogenicity and reproductive toxicity. The importance of monitoring for safety findings during development is highlighted. The document also covers specialized areas like safety pharmacology and assessments of abuse potential. Overall, the document outlines the extensive non-clinical testing done to evaluate a potential drug's safety profile before human studies.
Phase 1 protocol
This phase 1 clinical trial protocol aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a new investigational bronchodilator drug, CF-021, in healthy adult volunteers. The study is a randomized, open-label, single ascending oral dose trial. It will enroll approximately 30 subjects in sequential dose cohorts to determine the maximum tolerated dose of CF-021. Safety monitoring, pharmacokinetic profiling and bronchodilator effects will be assessed after single oral doses. The study aims to establish a safe clinical dosing range to enable further evaluation of CF-021 in phase 2 trials for chronic obstructive pulmonary disease.
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.
Chronic Toxicity Study (OECD TG-452).pptx
The document provides information on chronic toxicity studies as outlined in OECD Test Guideline 452. It discusses that chronic toxicity studies involve administering test substances to animals daily for over 90 days, typically 12 months, to identify target organs and dose-response relationships. The test substance is given orally, dermally, or via inhalation to groups of rodents like rats or mice, with at least 20 animals of each sex per dose group. Animals are observed closely for signs of toxicity and may be killed at interim periods or after 12 months for examination.
Csk toxi
This PowerPoint presentation covers various topics in toxicology including definitions, mechanisms of toxicity, toxicity studies guidelines, and types of toxicity like acute, subacute, chronic, genotoxicity, carcinogenicity, teratogenicity and mutagenicity. It defines toxicology and poison, explains dose-response relationships and toxicokinetics, and discusses the scope and pathophysiology of toxic exposures. Various toxicity studies like acute, 28-day repeated dose, and chronic toxicity studies are summarized along with parameters assessed. Mechanisms of toxicity, genotoxicity assays, and examples of carcinogens and teratogens like thalidomide are also outlined.
various approaches to drug discovery
clinical and preclinical approaches to drug discovery.Here we mainly deals with preclinical approaches, ie. Pharmacological approach and toxicological approach
Basics of Toxicology & Its role in Drug development-12-01-24.pdf
This presentation explains Basics of Toxicology and its Role in Drug development process
Preclinical & clinical sk
This document discusses the process of preclinical and clinical evaluation of new chemical entities from drug discovery through approval. In preclinical studies, potential new drugs are tested in animals to evaluate safety, toxicity, pharmacokinetics and pharmacodynamics. If results are promising, human clinical trials are conducted in phases to test safety and efficacy. Phase 0 involves microdosing, Phase I tests first use in humans, Phase II evaluates dosing and efficacy, and Phase III extends these tests to more patients in a blinded study. If successful, the drug can receive approval for marketing and ongoing monitoring in Phase IV. Preclinical data helps determine appropriate human dosing before moving to clinical trials.
Experimental Techniques For Evaluation Of New Drugs.ppt
Experimental techniques are used to evaluate new drugs for toxicity, efficacy, and safety prior to human clinical trials. This includes acute and chronic toxicity studies in two animal species to identify target organ toxicity and establish a maximum tolerated dose. Genotoxicity and carcinogenicity studies are also conducted to assess genetic damage and cancer risk. Alternative methods seek to reduce animal testing through computer models, cell cultures, and organ-specific assays.
animal toxicity studies
This document discusses various types of animal toxicity studies that are required before a drug can be administered to humans. It describes how these studies help establish the therapeutic index and predict adverse effects in humans. The key types of studies mentioned are systemic toxicity studies (including single dose, repeated dose, reproductive, and local toxicity), allergenicity/hypersensitivity studies, genotoxicity studies, and carcinogenicity/oncogenicity studies. Each type of study has specific objectives, test models used, parameters evaluated, and methods for conducting the studies and evaluating results. The studies aim to assess benefits and risks of drugs and establish their safety profiles before human use.
Phase clinicaltrial
Phase 1 clinical trials are the first studies done in humans of a new drug or treatment. They aim to determine the drug's safety and side effects, identify the maximum tolerated dose, and understand how the body processes the drug through pharmacokinetic evaluation. Phase 1 trials typically involve small groups of healthy volunteers or patients and start with low doses that are gradually increased. The results of phase 1 trials provide information needed to design subsequent clinical trial phases that further evaluate efficacy.
Toxi chap 3.ppt
Studies on general toxicity include acute, sub-acute, sub-chronic, and chronic toxicity studies to determine the effects of repeated exposure to a chemical over different time periods. Developmental and reproductive toxicity studies evaluate effects on fertility, pregnancy, and offspring. Mutagenicity studies test whether chemicals cause genetic mutations. Carcinogenicity studies involve long-term exposure of rodents to assess cancer potential. Immunotoxicity assessment evaluates impacts on the immune system.
Safety guidelines- S3A and S3B
S3A: NOTE FOR GUIDANCE ON TOXICOKINETICS: THE ASSESSMENT OF SYSTEMIC EXPOSURE IN TOXICITY STUDIES
S3B: PHARMACOKINETICS: GUIDANCE FOR REPEATED DOSE TISSUE DISTRIBUTION STUDIES
Similar to Session 2 part 3 (20)
Toxicokinetic evaluation in preclinical studies.pptx
Toxicokinetic evaluation in preclinical studies.pptx
Toxiocokinetic evaluation in preclinical studies.pptx
Toxiocokinetic evaluation in preclinical studies.pptx
Basics of Toxicology & Its role in Drug development-12-01-24.pdf
Basics of Toxicology & Its role in Drug development-12-01-24.pdf
Experimental Techniques For Evaluation Of New Drugs.ppt
Experimental Techniques For Evaluation Of New Drugs.ppt
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一比一原版(QMUE毕业证书)英国爱丁堡玛格丽特女王大学毕业证文凭如何办理
永久可查学历认证【微信：A575476】【(QMUE毕业证书)英国爱丁堡玛格丽特女王大学毕业证成绩单Offer】【微信：A575476】（留信学历认证永久存档查询）采用学校原版纸张、特殊工艺完全按照原版一比一制作（包括：隐形水印，阴影底纹，钢印LOGO烫金烫银，LOGO烫金烫银复合重叠，文字图案浮雕，激光镭射，紫外荧光，温感，复印防伪）行业标杆！精益求精，诚心合作，真诚制作！多年品质 ,按需精细制作，24小时接单,全套进口原装设备，十五年致力于帮助留学生解决难题，业务范围有加拿大、英国、澳洲、韩国、美国、新加坡，新西兰等学历材料，包您满意。
【业务选择办理准则】
一、工作未确定，回国需先给父母、亲戚朋友看下文凭的情况，办理一份就读学校的毕业证【微信：A575476】文凭即可
二、回国进私企、外企、自己做生意的情况，这些单位是不查询毕业证真伪的，而且国内没有渠道去查询国外文凭的真假，也不需要提供真实教育部认证。鉴于此，办理一份毕业证【微信：A575476】即可
三、进国企，银行，事业单位，考公务员等等，这些单位是必需要提供真实教育部认证的，办理教育部认证所需资料众多且烦琐，所有材料您都必须提供原件，我们凭借丰富的经验，快捷的绿色通道帮您快速整合材料，让您少走弯路。
留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
→ 【关于价格问题（保证一手价格）
我们所定的价格是非常合理的，而且我们现在做得单子大多数都是代理和回头客户介绍的所以一般现在有新的单子 我给客户的都是第一手的代理价格，因为我想坦诚对待大家 不想跟大家在价格方面浪费时间
对于老客户或者被老客户介绍过来的朋友，我们都会适当给一些优惠。
选择实体注册公司办理，更放心，更安全！我们的承诺：可来公司面谈，可签订合同，会陪同客户一起到教育部认证窗口递交认证材料，客户在教育部官方认证查询网站查询到认证通过结果后付款，不成功不收费！
Innovation Management Frameworks: Your Guide to Creativity & Innovation
Innovation Management Frameworks: Your Guide to Creativity & InnovationOperational Excellence Consulting
[To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
This PowerPoint compilation offers a comprehensive overview of 20 leading innovation management frameworks and methodologies, selected for their broad applicability across various industries and organizational contexts. These frameworks are valuable resources for a wide range of users, including business professionals, educators, and consultants.
Each framework is presented with visually engaging diagrams and templates, ensuring the content is both informative and appealing. While this compilation is thorough, please note that the slides are intended as supplementary resources and may not be sufficient for standalone instructional purposes.
This compilation is ideal for anyone looking to enhance their understanding of innovation management and drive meaningful change within their organization. Whether you aim to improve product development processes, enhance customer experiences, or drive digital transformation, these frameworks offer valuable insights and tools to help you achieve your goals.
INCLUDED FRAMEWORKS/MODELS:
1. Stanford’s Design Thinking
2. IDEO’s Human-Centered Design
3. Strategyzer’s Business Model Innovation
4. Lean Startup Methodology
5. Agile Innovation Framework
6. Doblin’s Ten Types of Innovation
7. McKinsey’s Three Horizons of Growth
8. Customer Journey Map
9. Christensen’s Disruptive Innovation Theory
10. Blue Ocean Strategy
11. Strategyn’s Jobs-To-Be-Done (JTBD) Framework with Job Map
12. Design Sprint Framework
13. The Double Diamond
14. Lean Six Sigma DMAIC
15. TRIZ Problem-Solving Framework
16. Edward de Bono’s Six Thinking Hats
17. Stage-Gate Model
18. Toyota’s Six Steps of Kaizen
19. Microsoft’s Digital Transformation Framework
20. Design for Six Sigma (DFSS)
To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentationsEllen Burstyn: From Detroit Dreamer to Hollywood Legend | CIO Women Magazine
In this article, we will dive into the extraordinary life of Ellen Burstyn, where the curtains rise on a story that's far more attractive than any script.
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Cover Story - China's Investment Leader - Dr. Alyce SU
In World Expo 2010 Shanghai – the most visited Expo in the World History
https://www.britannica.com/event/Expo-Shanghai-2010
China’s official organizer of the Expo, CCPIT (China Council for the Promotion of International Trade https://en.ccpit.org/) has chosen Dr. Alyce Su as the Cover Person with Cover Story, in the Expo’s official magazine distributed throughout the Expo, showcasing China’s New Generation of Leaders to the World.
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- 17. Complete Toxicology Profile Preliminary Evaluation Genetic Toxicology Battery Acute Toxicology Subchronic Toxicology (14-day to 90-days) Chronic Toxicology (6-month to 12-month) Oncogenic Studies (2-year) Genetic Toxicology Kinetics Acute and Multidose Tox in vitro Tox Definitive toxicokinetics Reproductive and Developmental Tox (timing affected by inclusion of WCBP) Environmental Assessment Toxicology of major human metabolites Toxicology of degradation products Safety Pharmacology Dorato, M. A., Vodicnik, M. J. The Toxicologic Assessment of Pharmaceutical and Biotechnology Products. in Principles and Methods of Toxicology . Raven Press, 1994