Clinical Trials: Trial Phases and design is a ppt on the different phases of the Clinical trials from Preclinical to Phase 4and the different trial designs that can be adapted to carry out the trial in humans. Preclinical phase is the phase in which trials are carried out in animals. On sucessful conduct of animal trials trials are continued in humans after filing an IND (Investigational New Drug application). The Phases in humans range from phase 1-4 besides which an additional phase called the phase 0 may be implemented in certain trials. The phase 0, also known as the microdosing phase reduces the entire duration of the trial. After Phase 3 of the trial an NDA (New Drug application) is filed to the regulatory authority, acceptance of which allows the drug to be released into the market. The phase 4 (Post Marketing surveillance) is the phase after the marketing of the drug which helps monitor adverse effects of the drug. Clinical trial dsigns are of different types based on intervention, randomisation and grouping. Few of which are case contol study, cohort study, cross sectional study and randomised contol trials. Randomised contol trials are of different types:
Parallel design: Patients are assigned and treatment is administered to two groups simultaneously: one with the investigational drug and the other with a placebo.
Crossover: Two groups are given two different treatments (A AND B) randomisation is on whether the group is given treatment A first or treatment B first, since both groups are given both the treatments.
Latin square design: 4 different treatments are given (placebo or standard) to 4 groups. The treatment are given in such a way that each patient gets each treatment atleast once.
Factorial design: 2 or more treatments are tested simultaneously such that treatment A vs control of treatment A and treatment B vs control of treatment B can be tested simultaneously.
This document summarizes a presentation on sponsor-CRO relationships given by David Selkirk. It outlines the pressures facing both pharmaceutical sponsors and CROs that are driving increased strategic partnerships between the two. These pressures include patent cliffs reducing drug revenues, increased competition, and the need for global clinical trial networks. The relationship has evolved from sponsors using CROs for occasional contract work to more long-term strategic alliances where both share planning and goal alignment. The future is expected to see continued outsourcing to large CRO strategic partners, more CRO specialization, and a focus on emerging markets, biosimilars, and patient-centered outcomes research.
The document discusses applying a lifecycle management model to analytical procedures. It proposes a three stage model: 1) Procedure Design involving development and understanding potential variables, 2) Procedure Performance Qualification demonstrating fitness for purpose, and 3) Continued Procedure Performance Verification involving routine monitoring. Key aspects include defining an Analytical Target Profile specifying performance criteria, conducting risk assessments of potential variables, and establishing control strategies. The lifecycle approach aims to better integrate validation, transfer, and verification, with the Analytical Target Profile serving as an overall reference point.
This document summarizes the key aspects of risk management in pharmacovigilance. It discusses how risk management aims to safely use drugs by identifying risks early and minimizing harmful effects. The important steps in risk management include developing a safety specification, pharmacovigilance plan, evaluating the need for risk minimization activities, and creating a risk minimization plan. These steps help identify risks, assess them, and communicate strategies to address safety concerns and optimize the benefit-risk profile of medications.
Randomized controlled trials (RCTs) provide the highest level of evidence in clinical research. RCTs involve randomly assigning subjects to experimental and control groups to test clinical interventions. Key aspects of RCTs include formulating a research question, randomization to eliminate confounding factors, blinding of subjects and researchers, monitoring outcomes in both groups, and presenting results including relative risk, efficacy and number needed to treat. Common RCT designs are parallel, cross-over and factorial designs. RCTs aim to discover safety and efficacy of clinical interventions.
The document outlines the various stages involved in the new drug discovery and development process, including target identification, validation and screening, lead identification and optimization, preclinical and clinical testing through four phases, regulatory approval, and post-marketing surveillance. It notes that it takes on average 12-15 years and $900 million to $2 billion to develop a new drug, with only one in 5,000-10,000 compounds ultimately being approved due to the high failure rate of drug candidates.
Placebo effect in clinical research is a fascinating and widely researched phenomenon in biomedical research and medicine in general. Presentation is an overview of origins and impact of placebo effect in development of new medicines.
Analytical method transfer involves qualifying a receiving laboratory to perform an analytical test procedure originally developed in a transferring laboratory. It ensures the receiving laboratory has the knowledge and ability to carry out the procedure as intended. There are different types of method transfers, including comparative testing, co-validation between laboratories, revalidation/partial validation, and waivers. Both the transferring and receiving laboratories have responsibilities in the method transfer process, which typically involves testing replicate samples, evaluating acceptance criteria, and documenting the transfer in a protocol.
Clinical Trials: Trial Phases and design is a ppt on the different phases of the Clinical trials from Preclinical to Phase 4and the different trial designs that can be adapted to carry out the trial in humans. Preclinical phase is the phase in which trials are carried out in animals. On sucessful conduct of animal trials trials are continued in humans after filing an IND (Investigational New Drug application). The Phases in humans range from phase 1-4 besides which an additional phase called the phase 0 may be implemented in certain trials. The phase 0, also known as the microdosing phase reduces the entire duration of the trial. After Phase 3 of the trial an NDA (New Drug application) is filed to the regulatory authority, acceptance of which allows the drug to be released into the market. The phase 4 (Post Marketing surveillance) is the phase after the marketing of the drug which helps monitor adverse effects of the drug. Clinical trial dsigns are of different types based on intervention, randomisation and grouping. Few of which are case contol study, cohort study, cross sectional study and randomised contol trials. Randomised contol trials are of different types:
Parallel design: Patients are assigned and treatment is administered to two groups simultaneously: one with the investigational drug and the other with a placebo.
Crossover: Two groups are given two different treatments (A AND B) randomisation is on whether the group is given treatment A first or treatment B first, since both groups are given both the treatments.
Latin square design: 4 different treatments are given (placebo or standard) to 4 groups. The treatment are given in such a way that each patient gets each treatment atleast once.
Factorial design: 2 or more treatments are tested simultaneously such that treatment A vs control of treatment A and treatment B vs control of treatment B can be tested simultaneously.
This document summarizes a presentation on sponsor-CRO relationships given by David Selkirk. It outlines the pressures facing both pharmaceutical sponsors and CROs that are driving increased strategic partnerships between the two. These pressures include patent cliffs reducing drug revenues, increased competition, and the need for global clinical trial networks. The relationship has evolved from sponsors using CROs for occasional contract work to more long-term strategic alliances where both share planning and goal alignment. The future is expected to see continued outsourcing to large CRO strategic partners, more CRO specialization, and a focus on emerging markets, biosimilars, and patient-centered outcomes research.
The document discusses applying a lifecycle management model to analytical procedures. It proposes a three stage model: 1) Procedure Design involving development and understanding potential variables, 2) Procedure Performance Qualification demonstrating fitness for purpose, and 3) Continued Procedure Performance Verification involving routine monitoring. Key aspects include defining an Analytical Target Profile specifying performance criteria, conducting risk assessments of potential variables, and establishing control strategies. The lifecycle approach aims to better integrate validation, transfer, and verification, with the Analytical Target Profile serving as an overall reference point.
This document summarizes the key aspects of risk management in pharmacovigilance. It discusses how risk management aims to safely use drugs by identifying risks early and minimizing harmful effects. The important steps in risk management include developing a safety specification, pharmacovigilance plan, evaluating the need for risk minimization activities, and creating a risk minimization plan. These steps help identify risks, assess them, and communicate strategies to address safety concerns and optimize the benefit-risk profile of medications.
Randomized controlled trials (RCTs) provide the highest level of evidence in clinical research. RCTs involve randomly assigning subjects to experimental and control groups to test clinical interventions. Key aspects of RCTs include formulating a research question, randomization to eliminate confounding factors, blinding of subjects and researchers, monitoring outcomes in both groups, and presenting results including relative risk, efficacy and number needed to treat. Common RCT designs are parallel, cross-over and factorial designs. RCTs aim to discover safety and efficacy of clinical interventions.
The document outlines the various stages involved in the new drug discovery and development process, including target identification, validation and screening, lead identification and optimization, preclinical and clinical testing through four phases, regulatory approval, and post-marketing surveillance. It notes that it takes on average 12-15 years and $900 million to $2 billion to develop a new drug, with only one in 5,000-10,000 compounds ultimately being approved due to the high failure rate of drug candidates.
Placebo effect in clinical research is a fascinating and widely researched phenomenon in biomedical research and medicine in general. Presentation is an overview of origins and impact of placebo effect in development of new medicines.
Analytical method transfer involves qualifying a receiving laboratory to perform an analytical test procedure originally developed in a transferring laboratory. It ensures the receiving laboratory has the knowledge and ability to carry out the procedure as intended. There are different types of method transfers, including comparative testing, co-validation between laboratories, revalidation/partial validation, and waivers. Both the transferring and receiving laboratories have responsibilities in the method transfer process, which typically involves testing replicate samples, evaluating acceptance criteria, and documenting the transfer in a protocol.
This document discusses different study designs used in research methodology. It begins with definitions of key concepts like independent and dependent variables. It explains the need for well-designed studies and important features. Different types of studies are described, including descriptive, analytical, experimental and observational designs. Experimental designs are discussed in more detail, covering principles of replication, randomization and local control. Different classification systems for epidemiological studies are also presented.
This presentation gives the details about career opportunities in clinical research, clinical research courses available in India and clinical research training.
This document discusses different types of study designs used in clinical research. It describes experimental designs like randomized clinical trials (RCTs) which are considered the highest level of evidence. It also covers observational study designs including cohort studies, case-control studies, cross-sectional studies, case series, and case reports. For each design it provides details on what it is, strengths, weaknesses and examples. It concludes with a brief overview of meta-analyses which systematically review and combine results from multiple studies.
USFDA guidelines for bioanalytical method validationbhatiaji123
The document discusses guidelines for bioanalytical method validation from the USFDA. It describes key parameters that must be validated for a bioanalytical method, including selectivity, accuracy, precision, recovery, calibration curves, sensitivity, reproducibility and stability. Accuracy and precision are determined by analyzing quality control samples in replicates across multiple runs. Recovery experiments compare extracted samples to unextracted standards. A calibration curve consisting of multiple concentrations over the expected range must be precise and reproducible.
The ICH Q1A guideline provides recommendations for conducting stability studies on drug substances and drug products to establish retest and shelf-life periods. Key points include:
- Stability studies should be conducted on 3 primary batches under long-term, intermediate, and accelerated storage conditions specified in the guideline.
- Testing frequency is typically every 3 months for the first year of long-term studies and specifications cover physical, chemical, biological, and microbiological attributes.
- The purpose is to evaluate how quality varies over time under influence of factors like temperature and humidity and provide evidence to support recommended storage conditions.
This document discusses non-inferiority clinical trials. It notes that non-inferiority trials are conducted when superiority trials are unethical or impractical. In a non-inferiority trial, the hypothesis is that a new treatment is not clinically inferior to the comparator by more than a pre-specified non-inferiority margin. Protocol deviations and lack of compliance can undermine non-inferiority trials by favoring the conclusion that treatments are non-inferior when they may actually be inferior. It is important that non-inferiority trials adhere closely to protocols and measure compliance to avoid invalid conclusions.
This document is a presentation on Quality by Design (QbD) in the pharmaceutical industry. It begins with an introduction comparing the traditional Quality by Test (QbT) approach to QbD. The presentation defines QbD and discusses ICH guidelines on QbD. It identifies key elements of QbD including Quality Target Product Profile, Critical Quality Attributes, Critical Material Attributes, Critical Process Parameters. The presentation outlines the steps for QbD implementation and importance of QbD in ensuring product quality and facilitating innovation.
Evaluating and Investigating Drug Safety Signals with Public DatabasesPerficient
This document provides an overview of databases that can be used to evaluate and investigate drug safety signals. It discusses common language and concepts in pharmacovigilance like signal detection, evaluation, and prioritization. It also describes online free databases like CDC WONDER and EU-ADR that can be used to search for drug-event pairs and investigate potential safety signals. Finally, it outlines some fee-based databases like those from Group Health Cooperative and Kaiser Permanente that contain patient healthcare records that can be used to conduct observational studies.
The document provides an overview of stability studies in the pharmaceutical industry. It defines stability as the ability of a substance to remain unchanged over time under specified storage and use conditions. The purpose of stability testing is to provide evidence on drug quality and define shelf life by permitting establishment of storage conditions, retest periods and labeling. Guidelines for stability testing are set by the International Conference on Harmonization (ICH). Stability studies must be conducted on multiple batches under long term, intermediate and accelerated conditions to evaluate the effect of time and various climatic factors on products. Data is used to establish shelf life or retest dates by extrapolation. Labeling must include any special storage instructions.
ICH Q6A Specifications by Chandra MohanChandra Mohan
The document provides guidelines on specifications for new drug substances and products. It defines specifications and outlines universal tests that should be included for both drug substances and products, such as description, identification, assay, and impurities. It also describes specific tests that may be included depending on the dosage form, such as dissolution, disintegration, hardness/friability for solid oral dosage forms. The guidelines provide information on justifying acceptance criteria and setting specifications based on development data and stability studies.
Ankica Mamić - Izrada komunikacijske strategije (odnosi s javnošću)Ankica Mamić
Ankica Mamić - svaka strategija u odnosima s javnošću im zadane elemente. Mora biti točna, realna i sveobuhvatna, ali također zahtjeva inpute svih ključnih stakeholdera za uspjeh
Overview on crossover trialsStatistical illustration “SPSS”Continues outcomeNouran Hamza, MSc, PgDPH
crossover design
is a repeated/longitudinal measurements design.
|
Patients (experimental units) cross over from one treatment to another during the trial course.
|
In contrast to a parallel design where patients are randomized to a treatment and remain on that treatment throughout the trial duration
Developing and maintaining strong relationships between the Sponsor and the selected CRO can make or break a clinical study. In this webinar, two experts with experience managing clinical programs from both a CRO and a Sponsor perspective provide tips and strategies for optimizing these relationships using real world examples.
This document provides information on cleaning validation and analytical method validation. It discusses key aspects of cleaning validation including protocols, sampling methods, acceptance criteria, and reports. It emphasizes that cleaning validation is important to prevent contamination between products manufactured using the same equipment. It also covers parameters that are important to validate analytical methods such as selectivity, precision, accuracy, linearity, and calibration curves. The document is a reference for professionals on best practices for cleaning validation and analytical method validation.
R&D GCP and Effective Site Management 011910Myron Pyzyk
This document discusses good clinical practice (GCP) guidelines and the clinical trial process. It provides an overview of the history and purpose of GCP, the drug development process including pre-clinical and clinical trial phases, ethical and regulatory issues, and key roles and responsibilities of those involved like investigators, sponsors, and institutional review boards. The presentation aims to help understand how GCP impacts study quality and the overall clinical trial process.
This document discusses analytical method validation. It provides definitions and guidelines for validating analytical methods from regulatory agencies. Key aspects of method validation discussed include accuracy, precision, specificity, range, linearity, limits of detection and quantification. Validation parameters are described for different types of analytical tests including identification, quantitative impurity tests and assays. Guidelines are provided for qualifying analytical instrumentation and categorizing instruments based on complexity.
A case study on audit of pharmaceutical companyYashadaKumbhar
The FDA conducted an audit of Alkem Laboratories' facility in Daman, India from March 19-27, 2018. The audit uncovered 5 main observations, including out of specification drug batches being distributed, destroyed quality logs, backlogged stability testing samples, lack of integration parameters in chromatography, and improperly stored stability samples without temperature control or monitoring. The FDA recommended Alkem improve its quality control unit, documentation practices, stability study processes, sanitary conditions, and employee training to address the issues found during the audit. News reports indicated Alkem's stock prices dropped in response to the audit findings.
Особенности разработки лекарственных препаратов в психиатрииidkpharma
Доклад ИФАРМА на III Всероссийской конференции «Актуальные вопросы доклинических и клинических исследований лекарственных средств и клинических испытаний медицинских изделий».
This document discusses different study designs used in research methodology. It begins with definitions of key concepts like independent and dependent variables. It explains the need for well-designed studies and important features. Different types of studies are described, including descriptive, analytical, experimental and observational designs. Experimental designs are discussed in more detail, covering principles of replication, randomization and local control. Different classification systems for epidemiological studies are also presented.
This presentation gives the details about career opportunities in clinical research, clinical research courses available in India and clinical research training.
This document discusses different types of study designs used in clinical research. It describes experimental designs like randomized clinical trials (RCTs) which are considered the highest level of evidence. It also covers observational study designs including cohort studies, case-control studies, cross-sectional studies, case series, and case reports. For each design it provides details on what it is, strengths, weaknesses and examples. It concludes with a brief overview of meta-analyses which systematically review and combine results from multiple studies.
USFDA guidelines for bioanalytical method validationbhatiaji123
The document discusses guidelines for bioanalytical method validation from the USFDA. It describes key parameters that must be validated for a bioanalytical method, including selectivity, accuracy, precision, recovery, calibration curves, sensitivity, reproducibility and stability. Accuracy and precision are determined by analyzing quality control samples in replicates across multiple runs. Recovery experiments compare extracted samples to unextracted standards. A calibration curve consisting of multiple concentrations over the expected range must be precise and reproducible.
The ICH Q1A guideline provides recommendations for conducting stability studies on drug substances and drug products to establish retest and shelf-life periods. Key points include:
- Stability studies should be conducted on 3 primary batches under long-term, intermediate, and accelerated storage conditions specified in the guideline.
- Testing frequency is typically every 3 months for the first year of long-term studies and specifications cover physical, chemical, biological, and microbiological attributes.
- The purpose is to evaluate how quality varies over time under influence of factors like temperature and humidity and provide evidence to support recommended storage conditions.
This document discusses non-inferiority clinical trials. It notes that non-inferiority trials are conducted when superiority trials are unethical or impractical. In a non-inferiority trial, the hypothesis is that a new treatment is not clinically inferior to the comparator by more than a pre-specified non-inferiority margin. Protocol deviations and lack of compliance can undermine non-inferiority trials by favoring the conclusion that treatments are non-inferior when they may actually be inferior. It is important that non-inferiority trials adhere closely to protocols and measure compliance to avoid invalid conclusions.
This document is a presentation on Quality by Design (QbD) in the pharmaceutical industry. It begins with an introduction comparing the traditional Quality by Test (QbT) approach to QbD. The presentation defines QbD and discusses ICH guidelines on QbD. It identifies key elements of QbD including Quality Target Product Profile, Critical Quality Attributes, Critical Material Attributes, Critical Process Parameters. The presentation outlines the steps for QbD implementation and importance of QbD in ensuring product quality and facilitating innovation.
Evaluating and Investigating Drug Safety Signals with Public DatabasesPerficient
This document provides an overview of databases that can be used to evaluate and investigate drug safety signals. It discusses common language and concepts in pharmacovigilance like signal detection, evaluation, and prioritization. It also describes online free databases like CDC WONDER and EU-ADR that can be used to search for drug-event pairs and investigate potential safety signals. Finally, it outlines some fee-based databases like those from Group Health Cooperative and Kaiser Permanente that contain patient healthcare records that can be used to conduct observational studies.
The document provides an overview of stability studies in the pharmaceutical industry. It defines stability as the ability of a substance to remain unchanged over time under specified storage and use conditions. The purpose of stability testing is to provide evidence on drug quality and define shelf life by permitting establishment of storage conditions, retest periods and labeling. Guidelines for stability testing are set by the International Conference on Harmonization (ICH). Stability studies must be conducted on multiple batches under long term, intermediate and accelerated conditions to evaluate the effect of time and various climatic factors on products. Data is used to establish shelf life or retest dates by extrapolation. Labeling must include any special storage instructions.
ICH Q6A Specifications by Chandra MohanChandra Mohan
The document provides guidelines on specifications for new drug substances and products. It defines specifications and outlines universal tests that should be included for both drug substances and products, such as description, identification, assay, and impurities. It also describes specific tests that may be included depending on the dosage form, such as dissolution, disintegration, hardness/friability for solid oral dosage forms. The guidelines provide information on justifying acceptance criteria and setting specifications based on development data and stability studies.
Ankica Mamić - Izrada komunikacijske strategije (odnosi s javnošću)Ankica Mamić
Ankica Mamić - svaka strategija u odnosima s javnošću im zadane elemente. Mora biti točna, realna i sveobuhvatna, ali također zahtjeva inpute svih ključnih stakeholdera za uspjeh
Overview on crossover trialsStatistical illustration “SPSS”Continues outcomeNouran Hamza, MSc, PgDPH
crossover design
is a repeated/longitudinal measurements design.
|
Patients (experimental units) cross over from one treatment to another during the trial course.
|
In contrast to a parallel design where patients are randomized to a treatment and remain on that treatment throughout the trial duration
Developing and maintaining strong relationships between the Sponsor and the selected CRO can make or break a clinical study. In this webinar, two experts with experience managing clinical programs from both a CRO and a Sponsor perspective provide tips and strategies for optimizing these relationships using real world examples.
This document provides information on cleaning validation and analytical method validation. It discusses key aspects of cleaning validation including protocols, sampling methods, acceptance criteria, and reports. It emphasizes that cleaning validation is important to prevent contamination between products manufactured using the same equipment. It also covers parameters that are important to validate analytical methods such as selectivity, precision, accuracy, linearity, and calibration curves. The document is a reference for professionals on best practices for cleaning validation and analytical method validation.
R&D GCP and Effective Site Management 011910Myron Pyzyk
This document discusses good clinical practice (GCP) guidelines and the clinical trial process. It provides an overview of the history and purpose of GCP, the drug development process including pre-clinical and clinical trial phases, ethical and regulatory issues, and key roles and responsibilities of those involved like investigators, sponsors, and institutional review boards. The presentation aims to help understand how GCP impacts study quality and the overall clinical trial process.
This document discusses analytical method validation. It provides definitions and guidelines for validating analytical methods from regulatory agencies. Key aspects of method validation discussed include accuracy, precision, specificity, range, linearity, limits of detection and quantification. Validation parameters are described for different types of analytical tests including identification, quantitative impurity tests and assays. Guidelines are provided for qualifying analytical instrumentation and categorizing instruments based on complexity.
A case study on audit of pharmaceutical companyYashadaKumbhar
The FDA conducted an audit of Alkem Laboratories' facility in Daman, India from March 19-27, 2018. The audit uncovered 5 main observations, including out of specification drug batches being distributed, destroyed quality logs, backlogged stability testing samples, lack of integration parameters in chromatography, and improperly stored stability samples without temperature control or monitoring. The FDA recommended Alkem improve its quality control unit, documentation practices, stability study processes, sanitary conditions, and employee training to address the issues found during the audit. News reports indicated Alkem's stock prices dropped in response to the audit findings.
Особенности разработки лекарственных препаратов в психиатрииidkpharma
Доклад ИФАРМА на III Всероссийской конференции «Актуальные вопросы доклинических и клинических исследований лекарственных средств и клинических испытаний медицинских изделий».
IPHARMA is a leading CRO in Russia and EAEU countries that offers full clinical trial services from early phase to registration. It has over 15 years of experience conducting trials across many therapeutic areas. IPHARMA's advantages include medical and regulatory expertise, experienced staff, and access to investigators and study sites across Russia. It manages all aspects of clinical trials including planning, approval, monitoring, and reporting.
Este documento describe los conceptos clave para el desarrollo de una campaña de comunicación efectiva, incluyendo la identificación del público objetivo, la diferenciación del producto, los objetivos y presupuesto de la campaña, y la coordinación y control de la campaña publicitaria.
This document contains a competency statement and resume for Ogechi Amarawuba Carl-Onyeukwu, an experienced HR professional with over 12 years of experience in oil and gas, telecommunications, and banking. They are seeking a challenging role that allows career growth while adding value to an organization. Their resume details their educational background and extensive professional experience in various HR roles.
Knowledge Engineers is an Toronto – based Software Development company, Software development in Toronto provide tech incubation and software solution. Our designers, software developers & business analysts can turn great ideas into something truly fantastic.
El documento habla sobre la Web 2.0 y sus características principales. Define la Web 2.0 como aquellos sitios web que facilitan el compartir información, la interoperabilidad, el diseño centrado en el usuario y la colaboración. Algunas características clave son que permite a los usuarios interactuar y crear contenido, así como ejemplos como redes sociales, wikis y blogs.
Nowshad is an electrical and electronics engineer with over 3 years of experience in Qatar. He has expertise in designing, installing, testing and commissioning electrical and low voltage control systems including Vesda fire detection, central battery backups, integration protocols, master clock systems and lighting controls. Nowshad is currently working as a testing and commissioning engineer at JBK Controls in Doha and has worked on major projects for Qatar Petroleum, Qatar Foundation and others. He is proficient in AutoCAD, programming languages and technical training.
El documento habla sobre la Web 2.0 y sus principales características. Explica que la Web 2.0 se caracteriza por la participación activa de los usuarios como contribuidores de contenido, a través de blogs, redes sociales, sitios creados por usuarios y etiquetado colectivo. También menciona algunas aplicaciones y servicios populares asociados con la Web 2.0 como Google Docs, Google Reader, SlideShare, Technorati y Delicious.
Este documento presenta una lista de precios de diferentes discos y platos diamantados para diversos materiales como hormigón, granito, acero y otros. Se describen brevemente las características y usos de cada producto.
Remya Fashions is a company name that was mentioned in the document. No other details were provided about Remya Fashions, such as what industry they are in, location, products/services offered, or any other relevant information. The single word "Remya Fashions" was the only text contained in the given document.
Stephen Hobbs has over 30 years of experience in construction, geotechnical testing, and soil stabilization. He has worked on numerous infrastructure projects in Australia and overseas, specializing in earthworks supervision and quality control. His roles have included laboratory management, field and staff supervision, client liaison and training, and ensuring conformance with specifications.
This document provides details for the kitchen renovation including wainscoting on the lower walls, a Ceaserstone countertop, Marmoleum Trace of Time flooring, and ANN SACKS JUTE glass tiles. It specifies a Schumacher BIRDS & BUTTERFLIES 2704420 wallpaper for the upper cabinets and lists information about the wallpaper pattern and manufacturer Schumacher, known for traditional American patterns found in landmark buildings like The White House.
Presentation of project proposal and design briefBrandon Cooper
This document discusses factors that affect the design, development, and success of an education administration project. It addresses the relationship between designers/producers and the project, how societal trends influence the design/production, and how creative/innovative approaches will be used. Specifically, it notes that simplicity is key, and that the design should be easily understood with no difficulty through techniques like pictures, videos, icons, headers, colors, spacing, and symbols. The target market of teenagers seeks interactivity with multimedia over large paragraphs of text.
Кластер биомедицинских технологий Фонда «Сколково» совместно с компаниями ОСТ Рус и GCT впервые провел в Гиперкубе образовательный семинар «Вывод медицинского препарата на рынок: от доклиники к регистрации. Практические аспекты».
ООО "иФарма" - контрактно-исследовательская организация Центра Высоких Технологий «ХимРар», специализирующаяся на проведении клинических исследований лекарственных препаратов российских и иностранных разработчиков.
Кластер биомедицинских технологий Фонда «Сколково» совместно с компаниями ОСТ Рус и GCT впервые провел в Гиперкубе образовательный семинар «Вывод медицинского препарата на рынок: от доклиники к регистрации. Практические аспекты».
Кластер биомедицинских технологий Фонда «Сколково» совместно с компаниями ОСТ Рус и GCT впервые провел в Гиперкубе образовательный семинар «Вывод медицинского препарата на рынок: от доклиники к регистрации. Практические аспекты».
GCP для разработчиков (спонсоров). Организация системы качества клинических и...idkpharma
Некачественно проведенные клинические исследования — синоним отсутствия их проведения. Качество и безопасность — фундамент, на котором держится фармацевтическая индустрия.
Кластер биомедицинских технологий Фонда «Сколково» совместно с компаниями ОСТ Рус и GCT впервые провел в Гиперкубе образовательный семинар «Вывод медицинского препарата на рынок: от доклиники к регистрации. Практические аспекты».
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IPHARMA is a contract research organization specialized in conducting clinical trials of investigational drugs in the Russian Federation and the EAEU.
Facing The Challenges Of Clinical Trials In Russia idkpharma
Russia presents several challenges for conducting clinical trials due to its vast territory with different climate zones, centralized healthcare system, and new regulations from the Eurasian Economic Union. Logistics of importing and distributing study drugs and supplies throughout Russia requires special considerations including customs clearance, packaging and labeling, storage and temperature-controlled transport, and accountability of inventory. Outsourcing to a qualified clinical research organization and warehouse can help address these challenges through regulatory expertise, qualified staff and facilities, temperature-controlled storage and transport, and coverage of Russia's major cities.
Система качества исследовательского центра - практические рекомендацииidkpharma
Организация системы качества важна не только для компании-разработчика, но и для исследовательского центра. Это значительно упрощает повседневную работу и предотвращает систематические ошибки.
Практические аспекты внедрения системы фармаконадзораidkpharma
С момента утверждения Правил надлежащей практики фармаконадзора ЕАЭС все спонсоры клинических исследований, а также держатели регистрационных удостоверений обязаны иметь организованную систему фармаконадзора в своих компаниях. ИФАРМА делится собственным опытом и дает практические рекомендации по внедрению системы фармаконадзора в компании.
Clinical trial protocol: strategy for successidkpharma
The document outlines the key elements of a successful clinical trial protocol. A protocol is a document that provides guidelines for a clinical trial, including its objectives, design, methodology, and organization. It aims to obtain appropriate data on a drug's clinical properties within the shortest timeline and at minimal cost, while ensuring patient safety and adherence to regulatory standards. The document discusses 10 essential elements for an effective protocol: medical expertise, prior experience, hypothesis, endpoints, safety measures, credibility, rationality, structure, simplicity, and legitimacy. It emphasizes the importance of a protocol in providing clear guidelines to ensure a clinical trial's objectives are achieved efficiently and ethically.
Pharmacovigilance in local clinical trialsidkpharma
This document discusses the responsibilities of sponsors and CROs regarding pharmacovigilance in local clinical trials. It outlines sponsors' responsibilities including maintaining standard operating procedures, reporting timelines for adverse events, and providing annual safety reports. It describes the roles and cooperation between medical departments at sponsors and CROs in activities like data collection, report preparation, safety monitoring, and medical writing. Key qualifications for medical department staff are discussed. Effective pharmacovigilance requires qualified teams, standard operating procedures, safety data management systems, and streamlined communication.
This document summarizes a workshop on effective clinical trial design. The workshop agenda covers phase 2 and 3 study concepts, adaptive design advantages and risks, and examples of successful adaptive design implementation. Adaptive designs allow modifying study elements based on interim data to make trials more efficient. Risks include bias if interim analyses are misinterpreted. Effective use requires well-planned studies, statistical validity, and oversight. Adaptive designs may improve drug development timelines for next-in-class drugs.
3. 3
ПРОТОКОЛ КЛИНИЧЕСКОГО ИССЛЕДОВАНИЯ
• Документ, который описывает цели, дизайн, методологию,
статистические аспекты и организацию исследования
ICH GCP, ГОСТ Р 52379-2005 «Надлежащая клиническая практика»
• Документ, в котором определяются цели, формы
организации и методология проведения клинического
исследования, статистические методы обработки
результатов такого исследования и меры по обеспечению
безопасности физических лиц, участвующих в
клиническом исследовании лекарственного препарата
Федеральный закон от 12 апреля 2010 г. N 61-ФЗ «Об обращении
лекарственных средств»
4. 4
ТАК ЧТО ЖЕ ТАКОЕ ПРОТОКОЛ?
Прикладная
научная
работа
Руководство
для
исследователя
Схема
лечения и
безопасность
пациента
Свод правил
для
монитора и
аудитора
Схема сбора
и анализа
данных
Смета для
выполнения
работ
Основание
для КИ и
регистрации
ЛП
5. 5
СУТЬ ПРОТОКОЛА КЛИНИЧЕСКОГО
ИССЛЕДОВАНИЯ
• Форма: Четкое структурированное руководство для всех участников
клинического исследования
• Цель: В кратчайшие сроки и с минимальным бюджетом получить
необходимые данные о клинических свойствах препарата при
соблюдении следующих условий:
• Медицинская и научная актуальность и обоснованность
• Обеспечение лечебного эффекта и/или безопасности для пациентов
• Соблюдение регуляторных требований и правил Надлежащей
Клинической Практики
• Результат: Данные, достаточные для принятия решения о регистрации
препарата, переходе на следующую фазу, дополнительных
исследованиях или завершении клинической разработки
6. 6
10 СОСТАВЛЯЮЩИХ УСПЕШНОГО
ПРОТОКОЛА
1. Медицинская экспертиза
2. Предшествующий опыт
3. Гипотеза
4. Конечные точки и методы оценки
5. Безопасность
6. Достоверность
7. Целесообразность
8. Структура
9. Простота
10. Правомерность
7. 7
1. МЕДИЦИНСКАЯ ЭКСПЕРТИЗА
• Стандарты лечения
• Международные
• Локальные
• Методы оценки эффективности
лечения
• Схемы лечения и базовая
терапия
• Новые препараты
• Особенности рынка
• Популяция пациентов
• Распространенность
• Особенности течения
заболевания: стадии,
обострение, рецидив
• Особенности анамнеза:
сопутствующие заболевания,
состояния, изменения со
стороны систем органов
• Ранее не леченные или
получающие стандартную
терапию
• Источники:
• Привлечение экспертов-лидеров мнений
• Сайты европейских, американских и российских врачебных ассоциаций
• http://roszdravnadzor.ru «Порядки и стандарты оказания медицинской
помощи»
8. 8
2. ПРЕДШЕСТВУЮЩИЙ ОПЫТ
• Предшествующие исследования
• Международные стандарты проведения
исследований
• Исследования препаратов в той же
нозологии
• Исследования препаратов того же класса
• Локальные требования к исследованиям
определенного типа
• Конкурентные исследования
• Свойства препарата
• Доклинические данные
• Клинические данные
• Свойства препаратов
того же класса
• Источники:
• http://clinicaltrials.gov
• http://grls.rosminzdrav.ru (Реестр ЛС, Реестр КИ)
• http://www.ema.europa.eu/ema/ «Guideline on clinical investigation of
medicinal products in the treatment of …»
• http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guida
nces/ucm064981.htm
9. 9
3. ГИПОТЕЗА
• Основная конечная точка
• Частота достижения эффекта
• Изменение показателя
• Гипотеза
• Превосходство
• Не уступающая [эффективность]
• Эквивалентность
Цель
исследования
Механизм
действия
препарата
Основная
конечная точка*
Гипотеза
Н0 ↔ На
Расчет размера
выборки
Длительность
терапии и
наблюдения
Способ сбора
данных
Алгоритм
принятия
решения
Ожидаемое
значение в группе
контроля
* Значимый показатель эффективности, безопасности или ФК
10. 10
4. КОНЕЧНЫЕ ТОЧКИ И МЕТОДЫ ОЦЕНКИ
• Цели и задачи исследования
• Основная (одна гипотеза)
• Дополнительные
• Поисковые
• Виды конечных точек
• Эффективности
• Безопасности
• Качества жизни
• Фармакокинетические
• Фармакодинамические
• Фармакогенетические
• Методы оценки
• Опрос
• Физикальные
• Лабораторные
• Инструментальные
• Шкалы, опросники, дневники
• Источник данных
• Исследователь
• Лаборатория
• «Оценщик»
• Пациент
• Лечащий врач
• Лицо, осуществляющее уход
11. 11
5. БЕЗОПАСНОСТЬ
• Обеспечение безопасности
• Критерии невключения
• Критерии досрочного
выведения
• Сопутствующая терапия
• Терапия спасения
• Запрещенные препараты
• Ограничение по питанию и
активности
• Контрацепция
• Незапланированные визиты
• Период наблюдения после
завершения исследуемой
терапии
• Сообщение о безопасности
• Ожидаемые нежелательные
реакции для исследуемого
препарата, препарата
сравнения и базовой терапии
• Процедуры сообщения о
НЯ/СНЯ/Беременности
• НЯ особого интереса
• Комитет по мониторингу
данных безопасности
• Процедура расслепления (для
двойных-слепых
исследований)
12. 12
6. ДОСТОВЕРНОСТЬ
• Контроль
• Рандомизация
• Двойной-слепой дизайн
• Плацебо контроль
• Сравнение с «золотым
стандартом»
• Исходный уровень
• Вводный (плацебо) период
• Сопоставимые по размеру группы
• Однородная популяция
• Жесткие критерии отбора
• Стабильная базовая терапия
• Инструменты
• Центральная лаборатория
• Валидированные методы
• Поверка и калибровка
оборудования
• Единые стандарты и методы расчета
• Инструкции по дозированию и
хранению препарата
• Валидированные шкалы
• Центральный оценщик
• Независимая экспертиза
• Комитет по мониторингу данных
• Обучение и тренинги
• Мониторинг
13. 13
7. ЦЕЛЕСООБРАЗНОСТЬ
• Реализовать
• Актуальность
• Выполнимость
• Согласованность
• Сэкономить ресурсы
• Стоимость
• Время
• Усилия
• Цена/качество
• Принять решение
• Минимизировать риски
• Отслеживать сигналы
• Вовремя остановиться
14. 14
8. СТРУКТУРА
1. Обоснование
2. Цели и задачи
3. Дизайн исследования
4. Популяция
5. Исследуемый препарат
6. Процедуры
7. Описание визитов
8. Обеспечение качества
9. Статистические методы
10. Административные
процедуры
11. Ссылки
• Титульная страница
• Страница одобрения
протокола
• Заявление Исследователя
• Контактная информация
• Синопсис
• Аббревиатуры
• Содержание
• Приложения
15. 15
9. ПРОСТОТА
• Простой понятный
язык, расшифровка
терминов и
сокращений
• Однозначные
формулировки, не
допускающие
двоякого толкования
• Доносить суть
вопроса, не
перегружать текст
«…совершенство
достигается не тогда,
когда уже нечего
прибавить, но когда уже
ничего нельзя отнять»
Антуан де Сент-Экзюпери
16. 16
10. ПРАВОМЕРНОСТЬ
• Нормативная база
• Этические аспекты
• Распределение
обязанностей
• Ведение
документации
• Обеспечение качества
• Конфиденциальность
• Ссылки и приложения
• Реквизиты документа
(версия и дата)
• Подпись Спонсора и
Исследователя
17. 17
ПОШАГОВОЕ СОЗДАНИЕ ПРОТОКОЛА
Шаг 1.
ИЗУЧЕНИЕ
МАТЕРИАЛА
Терапевтическая область
Предшествующий опыт
Доклинические и клинические данные
Мнение экспертов
Шаг 2.
ВЫРАБОТКА
КОНЦЕПЦИИ
Определение популяции
Схема лечения, группа контроля
Выбор дизайна, цели и конечной точки
Формулировка гипотезы
Step 3.
СОЗДАНИЕ
СИНОПСИСА
Создание общего плана исследования
Описание значимых аспектов
Проработка специфичных вопросов
График процедур исследования
Step 4.
ПРОЕКТ
ПРОТОКОЛА
Проработка всех разделов протокола
Детальное описание процедур
Step 5.
ФИНАЛИЗАЦИЯ
ПРОТОКОЛА
Проверка точности и согласованности
документа
18. 18
СПАСИБО ЗА ВНИМАНИЕ!
Наталья Востокова
Исполнительный директор
ООО «ИФАРМА»
Россия, 141400, МО, г. Химки
ул. Рабочая, д. 2а, корп. 1
Тел. +7 (495) 925-3074
Моб. +7 (926) 098-3633
Эл. адрес: nv@ipharma.ru
Веб-сайт: www.ipharma.ru