During our 45 min Pharmapendium webinar, our Pharmapendium expert Pooja Jain, showed us you how the Pharmacokinetic module in Pharmapendium can do the following:
- Make drug development project risk assessments
- Identify competitive opportunities in a therapeutic area or drug class
- Gain critical understanding to potential pharmacokinetic responses by looking at critical data such as food effects, concomitant drugs, co-morbidities and demographic effects
Pharmapendium is the only online resource for searching all drug approval review and correspondence documentation since 1938 (FDA/CDER/FOI archived FDA/ EMA EPAR approval document database), giving you unrivalled insights into the entire history of drug development and comparative data in preclinical, clinical and post-marketing phases.In this webinar we:
- Showed you how your peers are using Pharmapendium to successfully move drugs along the pipeline.
- Demonstrated how you can be “Better informed” and what this really means to you and your colleagues.
This document provides information about a privately owned CRO founded in 1998 with approximately 30 employees headquartered in Turku, Finland and a biomarker unit located in Oulu, Finland. The CRO offers preclinical disease models, models of hormone action, analytical services, and clinical biomarker measurements to over 80 global companies, including several big pharmaceutical companies. Key benefits of partnering with this CRO include fast and flexible access to innovative disease models, high quality research expertise, adherence to study protocols and schedules, and superior cost-to-performance ratio compared to competitors.
This document provides an overview of the antifungal drug amphotericin B, including its mechanism of action, antifungal spectrum, resistance, administration and dosing, pharmacokinetics, side effects, therapeutic uses, and adverse effects. It first introduces systemic fungal infections and the cellular structure and classification of fungi. It then focuses on describing in depth the mechanism by which amphotericin B acts, its antifungal effects, potential resistance issues, typical dosing and administration, pharmacokinetics, common side effects, therapeutic uses for treating fungal infections, and possible adverse effects.
Astellas pharma inc. – product pipeline review – 2012Rose088
The document announces a market research report from Global Market Direct titled "Astellas Pharma Inc. - Product Pipeline Review - 2012". The report provides data on Astellas Pharma Inc.'s research and development focus and pipeline of drug candidates, including those in clinical trials for conditions like transplantation. It includes information on pipeline molecules across various therapy areas and stages of development. Sample pages of the report can be requested by email.
PharmaCircle provides global content, analytics, and visualization tools covering the pharmaceutical, biotechnology, and drug delivery industries through its Premium Service platform which offers extensive proprietary data, analysis, and visualizations across various modules to help users in R&D, clinical, regulatory, and other areas of these industries with their research and decision-making. The Premium Service offers over 120,000 products and candidates in development, analytical tools, custom data services, and support from a team of industry analysts to provide a comprehensive single source of information.
This report provides an overview of the global pipeline for treatments of penile cancer. It details products in development from discovery through registration stages, including late and early clinical stage products. The report analyzes the pipeline based on factors like therapeutic class, administration route, and molecule type. It also profiles several late-stage pipeline products and provides company and drug descriptions. The report aims to help companies plan business strategies around the penile cancer therapeutic landscape.
Merck faces challenges with growth and is expected to pursue cost efficiencies, mergers and acquisitions with other large pharmaceutical companies, biotech firms, midsize pharmaceutical players, and generics manufacturers. Any new products must be carefully launched and marketed to avoid controversial safety issues like those with Vioxx. Regulatory bodies should be provided drug samples for testing after the drug's effects have been thoroughly evaluated in-house to avoid approval delays for future drugs. Merck may also seek to extend product patent durations where possible.
Pharma & Medical Devices Industry Research & Analysis | ArancaAranca
Aranca supports several global pharmaceutical and medical device companies with business research & market intelligence on new products & markets, competitor activities, regulatory environment, innovation trends, product pipelines and supply chain efficiency
Pharmapendium is the only online resource for searching all drug approval review and correspondence documentation since 1938 (FDA/CDER/FOI archived FDA/ EMA EPAR approval document database), giving you unrivalled insights into the entire history of drug development and comparative data in preclinical, clinical and post-marketing phases.In this webinar we:
- Showed you how your peers are using Pharmapendium to successfully move drugs along the pipeline.
- Demonstrated how you can be “Better informed” and what this really means to you and your colleagues.
This document provides information about a privately owned CRO founded in 1998 with approximately 30 employees headquartered in Turku, Finland and a biomarker unit located in Oulu, Finland. The CRO offers preclinical disease models, models of hormone action, analytical services, and clinical biomarker measurements to over 80 global companies, including several big pharmaceutical companies. Key benefits of partnering with this CRO include fast and flexible access to innovative disease models, high quality research expertise, adherence to study protocols and schedules, and superior cost-to-performance ratio compared to competitors.
This document provides an overview of the antifungal drug amphotericin B, including its mechanism of action, antifungal spectrum, resistance, administration and dosing, pharmacokinetics, side effects, therapeutic uses, and adverse effects. It first introduces systemic fungal infections and the cellular structure and classification of fungi. It then focuses on describing in depth the mechanism by which amphotericin B acts, its antifungal effects, potential resistance issues, typical dosing and administration, pharmacokinetics, common side effects, therapeutic uses for treating fungal infections, and possible adverse effects.
Astellas pharma inc. – product pipeline review – 2012Rose088
The document announces a market research report from Global Market Direct titled "Astellas Pharma Inc. - Product Pipeline Review - 2012". The report provides data on Astellas Pharma Inc.'s research and development focus and pipeline of drug candidates, including those in clinical trials for conditions like transplantation. It includes information on pipeline molecules across various therapy areas and stages of development. Sample pages of the report can be requested by email.
PharmaCircle provides global content, analytics, and visualization tools covering the pharmaceutical, biotechnology, and drug delivery industries through its Premium Service platform which offers extensive proprietary data, analysis, and visualizations across various modules to help users in R&D, clinical, regulatory, and other areas of these industries with their research and decision-making. The Premium Service offers over 120,000 products and candidates in development, analytical tools, custom data services, and support from a team of industry analysts to provide a comprehensive single source of information.
This report provides an overview of the global pipeline for treatments of penile cancer. It details products in development from discovery through registration stages, including late and early clinical stage products. The report analyzes the pipeline based on factors like therapeutic class, administration route, and molecule type. It also profiles several late-stage pipeline products and provides company and drug descriptions. The report aims to help companies plan business strategies around the penile cancer therapeutic landscape.
Merck faces challenges with growth and is expected to pursue cost efficiencies, mergers and acquisitions with other large pharmaceutical companies, biotech firms, midsize pharmaceutical players, and generics manufacturers. Any new products must be carefully launched and marketed to avoid controversial safety issues like those with Vioxx. Regulatory bodies should be provided drug samples for testing after the drug's effects have been thoroughly evaluated in-house to avoid approval delays for future drugs. Merck may also seek to extend product patent durations where possible.
Pharma & Medical Devices Industry Research & Analysis | ArancaAranca
Aranca supports several global pharmaceutical and medical device companies with business research & market intelligence on new products & markets, competitor activities, regulatory environment, innovation trends, product pipelines and supply chain efficiency
The document provides an overview of the global therapeutic pipeline for uveal melanoma as of the first half of 2015. It details the various drugs and therapies under investigation by companies and research institutions to treat uveal melanoma. Key players in this field are identified and individual drug profiles are included summarizing each treatment's description, mechanism of action, and development progress. The report aims to help decision making and research strategies regarding uveal melanoma therapeutic development.
7 tm pharma as – product pipeline review – 2012Rose088
The document summarizes a market research report on the product pipeline of 7TM Pharma A/S, a pharmaceutical company. It provides details on 7TM Pharma's current pipeline, including developmental stages of pipeline products across various therapy areas. Key pipeline molecules discussed include a drug for metabolic disorders, PAD program, TM30339, TM30510, and TM38837. The report also analyzes 7TM Pharma's research and development focus and pipeline.
SampleRX: Allscripts Open App Challengejakehalpert
SampleRX is a solution that integrates with electronic health records to provide physicians a virtual sample closet of medications selected by health plans for trial periods. This addresses rising drug costs for insurers and patients. The application promotes the most cost-effective medication options to reduce expenditures while easing patients' commitment to new prescriptions. It operates as a web application that integrates into EHRs like Allscripts through buttons and views. The prototype is being rolled out to large health systems and plans starting in late 2013 with a pricing model based on reduced drug spend.
This document outlines career opportunities for pharmacists with a B.Pharm or D.Pharm degree. It discusses options in hospital, retail, and wholesale pharmacy, as well as careers in sales, marketing, entrepreneurship, academics, and government jobs. It also describes opportunities in pharmaceutical industry roles like production, quality control, research and development, and clinical trials. Further education options like M.Pharm, Ph.D, management degrees, and programs abroad are listed. Software jobs in areas like pharmacovigilance and medical coding are mentioned. Finally, important pharmacy entrance exams for higher education and government jobs are outlined.
Macro genics, inc. – product pipeline review – 2012Rose088
This document summarizes a market research report about MacroGenics, Inc.'s product pipeline as of 2012. It provides an overview of MacroGenics' research areas, pipeline of products in development across various therapy areas and stages of the drug development process. It also includes brief profiles of some of MacroGenics' key pipeline products in development, such as DART for autoimmune disorders, DART mAbs, and monoclonal antibodies. The full report contains additional details on MacroGenics' pipeline like lists of tables and figures as well as related reports that can be purchased.
This document provides guidance on when updated Risk Management Plans (RMPs) should be submitted to the Therapeutic Goods Administration (TGA) for approved drugs in Australia and New Zealand. Updated RMPs should be submitted if there are significant changes to the risk-benefit analysis, new safety concerns, or changes to pharmacovigilance or risk minimization activities. Minor routine updates and changes unrelated to safety do not require RMP updates. Updated RMPs should follow the required format and include a summary of changes from the previous version. The TGA will acknowledge receipt and may request clarification or discussion if needed. Contact information is provided for questions.
The document announces the availability of a market research report on the pipeline of treatments for bacteremia from Aarkstore.com, providing an overview of therapeutic developments for bacteremia in clinical trials and by development stage, company, and drug properties. It also lists other related pipeline reports and contact information for the publisher.
AMR EISSA is a clinical and patient-oriented pharmacist with a bachelor's degree in pharmacy from Cairo University. He has over 10 years of experience in pharmaceutical production and care. He is proficient in quality control, production planning, and ensuring safety regulations are followed. He is also skilled in computer systems for drug information and references. Currently, he works as a production pharmacist developing standard operating procedures and overseeing production operations.
A general poster about the IUPHAR/BPS Guide to PHARMACOLOGY, updated for 2017. This works well used as a handout or pinned on departmental noticeboards.
Myriad genetics, inc. product pipeline analysisraja1233
Companyprofilesandconferences.com glad to promote a new report on "Myriad Genetics, Inc. (MYGN) - Product Pipeline Analysis" which is a source for data, analysis, and actionable intelligence on the company’s portfolio of pipeline products who provides key information about the company, its major products and brands.
Epithelial ovarian cancer – pipeline review, h2 2012Rose088
The document summarizes a market research report from Global Markets Direct titled "Epithelial Ovarian Cancer – Pipeline Review, H2 2012". The report provides an overview of the current therapeutic pipeline for epithelial ovarian cancer, including information on late stage projects, companies involved in development, and assessment of products by factors such as molecule type and administration route. It also lists key report sections such as executive summary, pipeline analysis, company profiles, and individual drug profiles.
The new Pharmacokinetics Module provides:
-unprecedented access to preclinical and clinical exposure data extracted from the entire history of FDA Approval Packages and EMEA documents
-Hundreds of thousands of PK, preclinical and clinical exposure, and drug safety data searchable and filterable in one platform
During our 45-minute webinar, Pooja Jain outlines the following:
- How your peers are using Pharmapendium to successfully move drugs along the pipeline.
- How you can be “Better informed” and what this really means to you and your colleagues.
Our introductory PharmaPendium webinar shows you:
- How your peers are using Pharmapendium to successfully move drugs along the pipeline.
- How you can be “Better informed” and what this really means to you and your colleagues.
PharmaPendium: Metabolizing enzymes and transporters May 14 2013Ann-Marie Roche
In this webinar, our PharmaPendium expert, Phillip Maclaughlin introduced the new module in PharmaPendium, showing the audience how they may better understand drug-drug interactions using this newly created data source.
This document outlines assignments for an entire course on alternative medicine. Students will:
1) Write a paper defining key terms of alternative medicine and describing its categories and philosophy.
2) Complete charts on alternative medical systems, complementary therapies, and dietary supplements.
3) Create a presentation assessing credibility of CAM information sources.
4) Write a team paper examining regulation of CAM therapies and how it affects consumers.
This document outlines assignments for an entire course on alternative medicine. Students will:
1) Write a paper defining key terms of alternative medicine and describing its categories and philosophy.
2) Complete charts on alternative medical systems, complementary therapies, and dietary supplements.
3) Create a presentation assessing credibility of CAM information sources.
4) Write a team paper examining regulation of CAM therapies and how it affects consumers.
This document outlines assignments for an entire course on alternative medicine. Students will:
1) Write a paper defining key terms of alternative medicine and describing its categories and philosophy.
2) Complete charts on alternative medical systems, complementary therapies, and dietary supplements.
3) Create a presentation assessing credibility of CAM information sources.
4) Write a team paper examining regulation of CAM therapies and how it affects consumers.
The document discusses the key stages in the drug discovery and development process including target selection, compound screening and hit optimization, selecting a drug candidate through further optimization of properties like absorption and metabolism, safety testing in animals and humans, proof of concept clinical trials in patients, large phase 3 clinical trials for registration and approval, and finally launch and life cycle management. It notes that the entire process from discovery to approval can take 12-16 years and cost over $1 billion.
Strategy for Preparation of GPAT
How to Start?
What to Refer?
Preparation of Pharmacology for GPAT
Understanding the Bonding between Subjects
What points to cover?
Points of Remembrance…
Bioequivalence – Still a Quality Achilles’ Heel? 16 October 2014Ajaz Hussain
This document summarizes a presentation on bioequivalence and pharmaceutical equivalence given by Dr. Ajaz Hussain. Some key points included:
- Pharmaceutical equivalence can be a vulnerable point and Achilles' heel if not properly ensured between generic and reference listed drugs.
- Quality by Design requires early investment in analytics to characterize reference listed drug variability and identify critical quality attributes.
- Lessons learned are that complex generic and biosimilar development share common challenges in demonstrating equivalence, and asking the right questions with the appropriate tools is important.
The document provides an overview of the global therapeutic pipeline for uveal melanoma as of the first half of 2015. It details the various drugs and therapies under investigation by companies and research institutions to treat uveal melanoma. Key players in this field are identified and individual drug profiles are included summarizing each treatment's description, mechanism of action, and development progress. The report aims to help decision making and research strategies regarding uveal melanoma therapeutic development.
7 tm pharma as – product pipeline review – 2012Rose088
The document summarizes a market research report on the product pipeline of 7TM Pharma A/S, a pharmaceutical company. It provides details on 7TM Pharma's current pipeline, including developmental stages of pipeline products across various therapy areas. Key pipeline molecules discussed include a drug for metabolic disorders, PAD program, TM30339, TM30510, and TM38837. The report also analyzes 7TM Pharma's research and development focus and pipeline.
SampleRX: Allscripts Open App Challengejakehalpert
SampleRX is a solution that integrates with electronic health records to provide physicians a virtual sample closet of medications selected by health plans for trial periods. This addresses rising drug costs for insurers and patients. The application promotes the most cost-effective medication options to reduce expenditures while easing patients' commitment to new prescriptions. It operates as a web application that integrates into EHRs like Allscripts through buttons and views. The prototype is being rolled out to large health systems and plans starting in late 2013 with a pricing model based on reduced drug spend.
This document outlines career opportunities for pharmacists with a B.Pharm or D.Pharm degree. It discusses options in hospital, retail, and wholesale pharmacy, as well as careers in sales, marketing, entrepreneurship, academics, and government jobs. It also describes opportunities in pharmaceutical industry roles like production, quality control, research and development, and clinical trials. Further education options like M.Pharm, Ph.D, management degrees, and programs abroad are listed. Software jobs in areas like pharmacovigilance and medical coding are mentioned. Finally, important pharmacy entrance exams for higher education and government jobs are outlined.
Macro genics, inc. – product pipeline review – 2012Rose088
This document summarizes a market research report about MacroGenics, Inc.'s product pipeline as of 2012. It provides an overview of MacroGenics' research areas, pipeline of products in development across various therapy areas and stages of the drug development process. It also includes brief profiles of some of MacroGenics' key pipeline products in development, such as DART for autoimmune disorders, DART mAbs, and monoclonal antibodies. The full report contains additional details on MacroGenics' pipeline like lists of tables and figures as well as related reports that can be purchased.
This document provides guidance on when updated Risk Management Plans (RMPs) should be submitted to the Therapeutic Goods Administration (TGA) for approved drugs in Australia and New Zealand. Updated RMPs should be submitted if there are significant changes to the risk-benefit analysis, new safety concerns, or changes to pharmacovigilance or risk minimization activities. Minor routine updates and changes unrelated to safety do not require RMP updates. Updated RMPs should follow the required format and include a summary of changes from the previous version. The TGA will acknowledge receipt and may request clarification or discussion if needed. Contact information is provided for questions.
The document announces the availability of a market research report on the pipeline of treatments for bacteremia from Aarkstore.com, providing an overview of therapeutic developments for bacteremia in clinical trials and by development stage, company, and drug properties. It also lists other related pipeline reports and contact information for the publisher.
AMR EISSA is a clinical and patient-oriented pharmacist with a bachelor's degree in pharmacy from Cairo University. He has over 10 years of experience in pharmaceutical production and care. He is proficient in quality control, production planning, and ensuring safety regulations are followed. He is also skilled in computer systems for drug information and references. Currently, he works as a production pharmacist developing standard operating procedures and overseeing production operations.
A general poster about the IUPHAR/BPS Guide to PHARMACOLOGY, updated for 2017. This works well used as a handout or pinned on departmental noticeboards.
Myriad genetics, inc. product pipeline analysisraja1233
Companyprofilesandconferences.com glad to promote a new report on "Myriad Genetics, Inc. (MYGN) - Product Pipeline Analysis" which is a source for data, analysis, and actionable intelligence on the company’s portfolio of pipeline products who provides key information about the company, its major products and brands.
Epithelial ovarian cancer – pipeline review, h2 2012Rose088
The document summarizes a market research report from Global Markets Direct titled "Epithelial Ovarian Cancer – Pipeline Review, H2 2012". The report provides an overview of the current therapeutic pipeline for epithelial ovarian cancer, including information on late stage projects, companies involved in development, and assessment of products by factors such as molecule type and administration route. It also lists key report sections such as executive summary, pipeline analysis, company profiles, and individual drug profiles.
The new Pharmacokinetics Module provides:
-unprecedented access to preclinical and clinical exposure data extracted from the entire history of FDA Approval Packages and EMEA documents
-Hundreds of thousands of PK, preclinical and clinical exposure, and drug safety data searchable and filterable in one platform
During our 45-minute webinar, Pooja Jain outlines the following:
- How your peers are using Pharmapendium to successfully move drugs along the pipeline.
- How you can be “Better informed” and what this really means to you and your colleagues.
Our introductory PharmaPendium webinar shows you:
- How your peers are using Pharmapendium to successfully move drugs along the pipeline.
- How you can be “Better informed” and what this really means to you and your colleagues.
PharmaPendium: Metabolizing enzymes and transporters May 14 2013Ann-Marie Roche
In this webinar, our PharmaPendium expert, Phillip Maclaughlin introduced the new module in PharmaPendium, showing the audience how they may better understand drug-drug interactions using this newly created data source.
This document outlines assignments for an entire course on alternative medicine. Students will:
1) Write a paper defining key terms of alternative medicine and describing its categories and philosophy.
2) Complete charts on alternative medical systems, complementary therapies, and dietary supplements.
3) Create a presentation assessing credibility of CAM information sources.
4) Write a team paper examining regulation of CAM therapies and how it affects consumers.
This document outlines assignments for an entire course on alternative medicine. Students will:
1) Write a paper defining key terms of alternative medicine and describing its categories and philosophy.
2) Complete charts on alternative medical systems, complementary therapies, and dietary supplements.
3) Create a presentation assessing credibility of CAM information sources.
4) Write a team paper examining regulation of CAM therapies and how it affects consumers.
This document outlines assignments for an entire course on alternative medicine. Students will:
1) Write a paper defining key terms of alternative medicine and describing its categories and philosophy.
2) Complete charts on alternative medical systems, complementary therapies, and dietary supplements.
3) Create a presentation assessing credibility of CAM information sources.
4) Write a team paper examining regulation of CAM therapies and how it affects consumers.
The document discusses the key stages in the drug discovery and development process including target selection, compound screening and hit optimization, selecting a drug candidate through further optimization of properties like absorption and metabolism, safety testing in animals and humans, proof of concept clinical trials in patients, large phase 3 clinical trials for registration and approval, and finally launch and life cycle management. It notes that the entire process from discovery to approval can take 12-16 years and cost over $1 billion.
Strategy for Preparation of GPAT
How to Start?
What to Refer?
Preparation of Pharmacology for GPAT
Understanding the Bonding between Subjects
What points to cover?
Points of Remembrance…
Bioequivalence – Still a Quality Achilles’ Heel? 16 October 2014Ajaz Hussain
This document summarizes a presentation on bioequivalence and pharmaceutical equivalence given by Dr. Ajaz Hussain. Some key points included:
- Pharmaceutical equivalence can be a vulnerable point and Achilles' heel if not properly ensured between generic and reference listed drugs.
- Quality by Design requires early investment in analytics to characterize reference listed drug variability and identify critical quality attributes.
- Lessons learned are that complex generic and biosimilar development share common challenges in demonstrating equivalence, and asking the right questions with the appropriate tools is important.
Week 5 Lab 3· If you choose to download the software from http.docxcockekeshia
Week 5 Lab 3
· If you choose to download the software from http://www.easyphp.org, use the installation guide provided here to install the EasyPHP.
Lab 3: XAMPP and MySQL Setup
Due Week 5 and worth 75 points
· Install XAMPP and MySQL and take a screen shot that shows the MySQL prompt on your screen. (screen shot optional)
· Research the capabilities of MySQL.
Write a one to two (1-2) page paper in which you:
1. Describe your experiences related to your setup of MySQL. Include any difficulties or issues that you had encountered during the installation.
1. Based on your post-installation research, describe the main capabilities of MySQL.
1. Describe the approach that you would take to go from a conceptual or logical model that you created to the implementation of that database structure in MySQL. Determine the additional information that you will need to implement the database design in a database management system.
Your assignment must follow these formatting requirements:
. Be typed, double spaced, using Times New Roman font (size 12), with one-inch margins on all sides; citations and references must follow APA or school-specific format. Check with your professor for any additional instructions.
. Include a cover page containing the title of the assignment, the student’s name, the professor’s name, the course title, and the date. The cover page and the reference page are not included in the required assignment page length.
Research studies show thatevidence-based practice(EBP) leads to higher qual-
ity care, improved patient out-
comes, reduced costs, and greater
nurse satisfaction than traditional
approaches to care.1-5 Despite
these favorable findings, many
nurses remain inconsistent in their
implementation of evidence-based
care. Moreover, some nurses,
whose education predates the in-
clusion of EBP in the nursing cur-
riculum, still lack the computer
and Internet search skills neces-
sary to implement these practices.
As a result, misconceptions about
EBP—that it’s too difficult or too
time-consuming—continue to
flourish.
In the first article in this series
(“Igniting a Spirit of Inquiry: An
Essential Foundation for Evidence-
Based Practice,” November 2009),
we described EBP as a problem-
solving approach to the delivery
of health care that integrates the
best evidence from well-designed
studies and patient care data,
and combines it with patient
preferences and values and nurse
expertise. We also addressed the
contribution of EBP to improved
care and patient outcomes, de-
scribed barriers to EBP as well as
factors facilitating its implementa-
tion, and discussed strategies for
igniting a spirit of inquiry in clin-
ical practice, which is the founda-
tion of EBP, referred to as Step
Zero. (Editor’s note: although
EBP has seven steps, they are
numbered zero to six.) In this
article, we offer a brief overview
of the multistep EBP process.
Future articles will elaborate on
each of the EBP steps, using
the context provided by the
Cas.
Pharmacogenomics annotation in drug structured product labeling for clinical ...Richard Boyce, PhD
The document discusses expanding the structured product label (SPL) model to include annotations of pharmacogenomic information. Currently, SPLs contain unstructured text descriptions of pharmacogenomic biomarkers and their implications for drugs. Annotations could normalize this information by linking specific drug-biomarker-recommendation relationships. This would enable more advanced decision support and knowledge discovery. The presentation provides an example of how pharmacists are annotating labels to express pharmacogenomic statements as structured data using the Open Annotation model.
Regulatory affairs and Intellectual Property Rightssantoshnarla
The document provides details about Dr. Santosh Kumar Narla's academic and professional background. It states that he holds a Ph.D. in Pharmaceutical Sciences and has over 15 years of experience in formulation development and regulatory affairs. He currently works as a manager of regulatory affairs at Dr. Reddy's Laboratories in Hyderabad. It also lists his publications and presentations at national and international conferences.
Literature monitoring for pv what are we doing at galderma elsevier webinarAnn-Marie Roche
The document discusses literature monitoring for pharmacovigilance. It describes weekly monitoring of individual case safety reports and periodic monitoring through development safety update reports and periodic benefit-risk evaluation reports. Key databases for literature searches are Medline and Embase. While Embase has more extensive drug coverage, searches on Medline via PubMed are more reliable due to the potential for loss of MeSH subheadings when mapping to Emtree and the risk of false negatives and positives when searching Embase alone. Literature searches support signal detection and periodic evaluation of a product's safety profile.
Embase for pharmacovigilance: Search and validation March 22 2017Ann-Marie Roche
Scientific literature plays a critical role in Pharmacovigilance and Drug Safety workflows. Monitoring literature for mentions of adverse drug reactions (ADRs) is mandated by regulatory bodies, and marketing authorization holders (MAHs) that do not properly report ADRs can be subject to heavy fines. With an increasing volume of unstructured content to cover, along with rising labor costs, MAHs are looking for ways to make their literature monitoring more effective and efficient.
Abstract and indexing (A&I) databases play an important role in Literature Monitoring – due to the vast amount of scientific literature published daily – in order for MAH’s to locate specific articles or conference presentations that may be relevant for their products (for both benefit/risk analysis and ADR detection). Rather than reading all the literature, MAH’s create search strategies that identify the relevant records in A&I databases and execute the searches regularly. GVP module VI mandates that searches are done at least weekly, but many companies maintain a daily monitoring and review cycle.
In this webinar, Senior Product Development Manager Embase, Dr. Ivan Krstic discussed best practices for saving time, staying current, validating search strategies and mitigating risk in the face of these increasingly complex processes in literature monitoring
The document discusses the key aspects and purpose of an investigator brochure (IB). The IB is prepared by the sponsor of a clinical trial to provide essential information about the investigational product to investigators. It contains a comprehensive summary of relevant non-clinical and clinical data, including information on pharmacology, toxicology, safety and efficacy from previous human trials. The goal is to inform investigators of risks and monitoring needs for the safe and proper conduct of the clinical trial. The IB is an important document that is reviewed annually and made available to investigators and ethics committees.
Successful New Drug Development Strategies for Small Companiesfrancjohn
This document provides advice for small biotech companies on successful new drug development. It emphasizes that new drug development is a risky process, with many potential pitfalls that can cause drugs to fail. Some key recommendations include understanding the strengths and weaknesses of the drug, learning from previous similar drugs, rigorously selecting preclinical and clinical doses, focusing on efficacy biomarkers with potential, and considering partnerships if drug delivery technology could help. The document stresses that drug development is a marathon, not a sprint, and one should not oversell the science until it is proven.
Similar to Searching for pharmacokinetic data in Pharmapendium (20)
How predictive models help Medicinal Chemists design better drugs_webinarAnn-Marie Roche
All scientific disciplines, including medicinal chemistry, are experiencing a revolution in unprecedented rates of data being generated and the subsequent analysis and exploitation of this data is increasingly fundamental to innovation. Using data to design better compounds is a challenge for Medicinal and Computational chemists.
The design of small-molecule drug candidates, encompassing characteristics such as potency, selectivity and ADMET (absorption, distribution, metabolism, excretion and toxicity) is a key factor in the success of clinical trials and computer-aided drug discovery/design methods have played a major role in the development of therapeutically important small molecules for over three decades. These methods are broadly classified as either structure-based or ligand-based.
In this webinar our expert Dr. Olivier Barberan will discuss ligand-based methods and he will cover the following:
How to use only ligand information to predict activity depending on its similarity/dissimilarity to previously known active ligands.
- Discuss ligand-based pharmacophores, molecular descriptors, and quantitative structure-activity relationships and important tools such as target/ligand databases necessary for successful implementation of various computer-aided drug discovery/design methods in a drug discovery campaign.
Webinar: New RMC - Your lead_optimization Solution June082017Ann-Marie Roche
The document discusses Reaxys Medicinal Chemistry and how it supports hit-to-lead and lead optimization processes. It provides high quality data on topics like efficacy, ADMET properties, and animal models to help computational and medicinal chemists. The pX concept normalizes bioactivity measurements like IC50, Ki, and % inhibition into a single comparable metric, making it possible to compare compound affinity regardless of the metric reported. This allows researchers to more easily search for and analyze active compounds.
Oil&Gas Thought Leader Webinar - New Plays for Old Ideas - Dr.Gabor TariAnn-Marie Roche
In our April 2017 webinar, three industry experts shared their research and demonstrated the importance of focusing on fundamental geologic and geophysical research approaches that integrate variety of data, information and concepts from disparate sources and related disciplines.
This back-to-fundamentals research can both inspire and accelerate exploration teams’ thinking about petroleum systems and lead to a path to success.
Dr Gabor Tari is currently the Group Chief Geologist at OMV. He has over 20 years’ experience working in upstream oil & gas and has worked for Amoco, BP, and Vanco, before joining OMV in 2007. Gabor has worked on exploration projects in basins around the globe, including Romania, Angola, North Africa, and the Middle East. He has authored over 50 scientific publications, presented papers at dozens of conferences, and most recently co-authored the book Permo-Triassic Salt Provinces of Europe, North Africa and the Atlantic Margins, with Dr Joan Flinch (Repsol) and Juan Soto, Professor of Geodynamics in the Granada University and in the Instituto Andaluz de Ciencias de la Tierra, Spain, which is currently available from Elsevier for pre-order online.
Gabor discussed and shared some examples of how new plays can be built on a solid foundation of petroleum system development and research, and how new ideas can be garnered from building on published research of oil & gas companies, academia, service providers and consultants.
Oil&Gas Thought-Leader Webinar - New Plays for Old Ideas - Dr. Rob ForknerAnn-Marie Roche
In our April 2017 webinar, three industry experts shared their research and demonstrated the importance of focusing on fundamental geologic and geophysical research approaches that integrate variety of data, information and concepts from disparate sources and related disciplines. This back-to-fundamentals research can both inspire and accelerate exploration teams’ thinking about petroleum systems and lead to a path to success.
Dr Rob Forkner is a carbonate geologist at Statoil, working in the carbonate plays and reservoirs research group in Austin, Texas, focusing on carbonate play prediction in Atlantic margin systems. Prior to Statoil, Rob worked at Maersk and Shell in onshore and offshore in well planning, geosteering, high-resolution sequence stratigraphy and facies prediction, carbonate sedimentology in unconventional assets, evaporite classification and prediction, rock typing, and more recently, carbonate system suppression and recovery during Oceanic Anoxic Events.
Oil&Gas Thought-Leader Webinar - New Plays for Old Ideas - Dr. Sander HoubenAnn-Marie Roche
Dr. Sander Houben presented on combining paleoceanographic and exploration tools to study Early Jurassic anoxic events. He discussed how carbon isotopes can be used as a stratigraphic tool to analyze perturbations to the carbon cycle during these events. Palynological analysis of indicators of photic zone anoxia and chemocline migration provided insight into changes in water column ecology. A case study of the Toarcian OAE and Posidonia Shale Formation showed how isotopic analyses revealed a major increase in export of hydrogen-rich organic matter due to intensified primary productivity by diazotrophs under low oxygen conditions. Paleoceanographic observations combined with an exploration geology perspective provided understanding of the formation of
Literature Management for Pharmacovigilance: Outsource or in-house solution? ...Ann-Marie Roche
Pharmaceutical companies are required to screen scientific literature on a regular basis and this comes with many challenges, such as handling large amounts of data, building search strings and integrating EMA MLM results. Out-sourcing literature screening to service providers reduces the workload for the PV-team, but how does it impact the literature management process overall? Maybe it results in decreased oversight and additional activities like audits and reconciliation? And what about building the search strategy?
During this webinar our PV expert, Dr. Joyce De Langen spoke about the following:
• The importance of literature management in Pharmacovigilance and the challenges.
• An evaluation of the benefits and risks of outsourcing literature management versus alternative solutions.
About the speaker:
Joyce de Langen, Ph.D has more than 10 years of experience in the domain of pharmacovigilance and drug safety. Through her work in the pharmaceutical industry, academia and regulatory authorities, Joyce has developed a broad perspective and knowledge in pharmacovigilance and drug safety.
Finding the right medical device information in embase 11 2016Ann-Marie Roche
The document discusses guidelines for systematic reviews of biomedical literature in Clinical Evaluation Reports (CERs) for medical devices, highlighting how Embase addresses the requirements through its comprehensive indexing of devices, manufacturers, and adverse effects, as well as features for building sensitive searches. It also provides examples of searches in Embase to find information on device clinical performance, comparisons, and safety for a case study on an everolimus eluting coronary stent.
The document discusses medical device adverse event reporting requirements, including definitions of reportable events and timelines for submitting reports to regulatory agencies. It provides an overview of the classification system for medical devices and regulations around reporting malfunctions, deaths and serious injuries caused by devices. Reporting requirements and challenges involving software as a medical device are also reviewed.
The All-New 2016 Engineering Academic Challenge - developed by students for students
The Engineering Academic Challenge (formerly as the Knovel Academic Challenge) is an immersive, 5-week interactive problem-set competition, featuring weekly thematic engineering challenges built around five transdisciplinary themes inspired by the National Academy of Engineering Grand Challenges.
This document discusses how drug analytics based on manually extracted semantic relationships in Embase can be useful for drug development, repurposing, and safety. It describes how relationships between drugs, diseases, and adverse reactions that are manually indexed can provide valuable information for drug repurposing, development, and safety. Specific examples are provided to show how the semantic relationships can guide drug repositioning strategies, investigate new combination drugs, identify drug-drug interactions, collect drug comparison data, and help improve risk management.
This document discusses Lean Six Sigma and resources available through Knovel to support Lean Six Sigma implementation. It provides an overview of the Lean Six Sigma implementation process including strategic leadership and vision, deployment planning, and execution and results. It describes Knovel's Lean Six Sigma resources such as handbooks, case studies, templates, and guides covering tools like DMAIC, DOE, SPC etc. that can help with the different belts and project phases from Define to Control. Other resources discussed include those for Design for Six Sigma and practical applications/case studies.
Reaxys provides a unified information portal that integrates data from multiple chemistry sources through a single interface. It links chemistry data, structures, citations, and full-text articles. Reaxys also integrates in-house data from sources like electronic lab notebooks through its API and can be used for activities like compound screening, literature searching, and patent analysis to support drug discovery.
Phil Lorenzi discusses pathway analysis approaches and their uses in biomedical research and drug development. He compares strategies for analyzing the autophagy and apoptosis pathways, finding that integrating multiple methods provides the most comprehensive understanding. Lorenzi also provides examples of how pathway analysis could have predicted problems with COX-2 inhibitors and helped explain past failures of AKT inhibitors. He concludes that pathway analysis is consistent with approvals of EGFR, MEK, RANKL and PARP inhibitors and may support development of GLS inhibitors.
Searching literature databases for post authorisation safety studies (pass)Ann-Marie Roche
This document discusses using literature databases like Embase to conduct post-authorization safety studies (PASS) through systematic literature reviews and meta-analyses. It provides an example PASS on the drug brentuximab vedotin that identified adverse events like peripheral neuropathy and infections. The document reviews how to structure a literature search using the PICO framework and Embase's in-depth indexing of concepts, relationships, and causality to comprehensively identify safety outcomes reported for a drug.
Julie glanville embase sunrise seminar may 2016Ann-Marie Roche
Simple text mining tools can help Embase users in several ways:
- Frequency analysis of terms in records can identify useful search terms and concepts to explore. Tools like EndNote and Voyant allow viewing frequencies of words in titles, abstracts, and subject headings.
- Phrase analysis identifies common word combinations or concepts in the text, beyond single words. Voyant and TERMINE are useful for this.
- Word collocation analysis shows which words frequently occur near each other, suggesting relationships between ideas. The Voyant collocates tool supports this.
- Cluster and network visualizations identify major themes or concepts within a set of records. VOSviewer creates visual maps of related terms.
Exploring records
Ian crowlesmith embase retrospective mla 2016Ann-Marie Roche
Embase began in 1946 as Excerpta Medica, founded to provide medical abstracts. It was acquired by Elsevier in 1971 and became available online in 1978. Key developments included introducing a controlled vocabulary called Emtree in 1987 and adding item types and check tags for evidence-based medicine in 1990. Currently, Embase indexes articles in great depth using natural language and extensively covers drugs and devices. The taxonomy Emtree is regularly updated to reflect new terms.
The document provides an update on new features and enhancements to Embase.com. Key points include:
- The addition of a new PICO search page that allows users to build clinical searches by splitting questions into Patient, Intervention, Comparison, and Outcome elements.
- Other enhancements include improved search tips, the ability to add synonyms and view all abstracts, as well as analytics capabilities for drug safety and repurposing based on triple indexing of content.
- Future plans include improvements to content, taxonomy, and indexing as well as a revamp of the search platform interface and functionality.
This document discusses upcoming changes to process safety management (PSM) regulations and standards. It notes several major industrial accidents in recent decades that prompted reforms. New PSM requirements in California will likely be adopted more widely and require more prescriptive tasks, reporting, and accountability. To ensure future PSM success, the document recommends: making no distinction between internal/external compliance; expanding the definition of mechanical integrity; understanding "double jeopardy"; not replacing investigations with management of change; knowing what the operations team is doing; and clarifying teamwork expectations regarding stop work authorizations.
This document describes a collaboration between Findacure, a UK charity focused on rare diseases, and Elsevier to mobilize informational resources for congenital hyperinsulinism (CHI), a rare genetic disease. Elsevier will provide Findacure access to its extensive literature database and text mining capabilities to summarize what is known about CHI mechanisms, identify potential drug targets, and find approved drugs that may treat CHI. The collaboration aims to support Findacure's efforts to drive research, develop treatments, and help patients by providing structured, analyzed information extracted from Elsevier's literature and linking researchers and institutions working on CHI.
Dr. Su Golder, NIHR Research Fellow at the University of York, presents findings from her recent publication: “Systematic review on the prevalence, frequency and comparative value of adverse events data in social media”.
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3. Need to know
Webinar control panel:
‘chat’ or ‘ask a question’ for questions
and comments
Option for full screen view
Q&A after presentation
3/9
4. Pharmacokinetics Module:
Value
Unprecedented access to Preclinical and Clinical exposure data extracted
from FDA packages (current & historic) and EMEA documents.
• ~2,000 drugs with preclinical and clinical exposure data at multiple
parameters and usually under various experimental conditions:
• Concomitant drugs, disease states, demographic differences, etc.
• The level of PK data to be contained in this database is almost never
published (competitive reasons) at this level of detail.
Pharmacokinetics, preclinical and clinical, & Drug Safety databases
browsable within the same platform.
4/9
5. Pharmacokinetics Module:
Content
Extracted parameter values for at least 2,000 drugs, taken from :
• FDA Reviews from 1938-Present (FDA Approval Packages)
• If you do not have FDA Classic Collection, you will have acesss to
extracted data, and citation, but will not be able to drill-in to the
original document.
• EMEA EPARs from ~1995 – Present
5/9
6. Pharmacokinetics Module:
Content
• Will contain an estimated 1.25 million lines of extracted
pharmacokinetics observations
• With filterable fields and special designations for:
• Drug name, Species, Study Group (population), Dose, Route,
Parameter, Value (normalized in searching), SD
• Enantiomers, Metabolites, Tissue-specific studies,
Concomitants (Food Effects)
6/9
7. Pharmacokinetics Module:
Sample Uses
Creating Modeling Sets: valuable data in modeling therapeutic window for
new drugs
Drug Development Project assessments
• A newly-available wealth of comparative data to aid in development
candidates’ decisions, prioritizations, and direction.
7/9
8. Pharmacokinetics Module:
Sample Uses
Competitive Opportunity:
• Can we deliver this drug better than our competitors?
• Where has the bar been set in this drug class?
• Where are the opportunities in Drug Class X using our proprietary
methods / formulations?
8/9
10. How may I find protein binding data
for the same drug in animal and
human studies?
Check notes for all solutions in PP
10/X
11. Now let’s see what kind of data we can find if we
look up for example, a drug called Aromasin, a
prescription medicine for the treatment of breast
cancer.
Check notes for all solutions in PP
11/X
12. Now let’s look for protein binding differences for
another drug, Rosuvastatin. Rosuvastatin is a
member of the drug class statins and is used for
lowering cholesterol. Now if we go under clinical
data and select for bioavailability, I would like to
show you what other types of insights you can
get.
Check notes for all solutions in PP
12/X
13. POLL
The poll should appear on your screen shortly….
13/9
13
14. So if we want to see how we can find
metabolite data using the PK module
in PP, let’s click on the PK tab.
Check notes for all solutions in PP
14/X
15. Now, if we want to see how we can find Cmax
data using the PK module in PP, based on what
you have seen already, we can probably not
only look for Cmax data, but also ask questions
like, is Cmax affected by fed vs fasted states?
Will this in turn affect the bioavailability of the
drug?
Check notes for all solutions in PP
15/X
16. So now, if we want to find some interesting
Tmax data, which is data pertaining to how long
it takes to reach Cmax, we can for example look
at analgesics. So we can go under drugs and
drug classes. Click on analgesics and add it.
Then under the PK parameters, we can click on
Distribution, then time values, and then tmax.
Then we click search now. And here you can
see all the results.
Check notes for all solutions in PP
16/X
18. The Q&A will be sent to you by email.
For more information and questions please contact
bdtraining@elsevier.com
The next PharmaPendium webinar is an introductory
webinar and will be on the 27th of June.
Go to www.trainingdesk.elsevier.com/pharmapendium for
all training related materials.
Please fill out the survey that
appears on your screen after
leaving the webinar.
18/9
Editor's Notes
Welcome to this webinar about PharmaPendium, focusing on finding Pharmacokinetic data. My name is Ann-Marie and I am your host today. I am here with our PharmaPendium expert Pooja Jain. Pooja comes with over 10 years of experience in the life sciences industry where she has experience working, for example, at Mimetogen Pharmaceuticals and Eli Lilly. Pooja has both a Master’s in Molecular Biology and an MBA degree and is here to educate us more on the pharmacokinetic module of PharmaPendium, such as how you may make drug development project risk assessments, identify competitive opportunities in a therapeutic area or drug class and gain critical understanding to potential pharmacokinetic responses by looking at critical data such as food effects, concomitant drugs, co-morbidities and demographic effects. We will be placing this webinar online so you can listen to it again, at your own pace! This webinar is aimed at users with some experience with PP. Introductions to PP are also offered and the next introductory webinar is scheduled for June 27 th .
Before we get started, I would briefly like to put PharmaPendium into context with the other activities that go on at Elsevier. Elsevier serves 3 main and interlinked areas, some of which may be of interest to you, Biology, Chemistry and Medicine. [first click] Pharmapendium, gives you searchable access to all FDA and EMA approval documentation and we also provide additional solutions serving the biology and medicine spheres, such as Embase for your biomedical literature searching needs, SciVerse ScienceDirect for full-text access and SciVerse Scopus, an all-science abstract and citation database. [second click] This should help put PharmaPendium into context, and with that we are almost ready to move to today’s session, which Pooja will be taking us through.
Just before we get started, a couple of need to knows. During the session you may send us your questions by using the chat or Ask a Question function on the webinar control panel. We will have 15 minutes for questions at the end and for those questions we do not answer in the webinar, they will be included in a complete Q&A sent to all attendees by email. If you wish to have a full screen view, please click on the red arrow. Your control panel will be hidden. Click again on the red arrow to see your control panel again. Pooja, welcome, could you briefly introduce yourself and tell us all about PharmaPendium?
Well let’s take the drug Enablex. Enablex is a prescription medicine used in adults for the treatment of overactive bladder. Let’s see what kind of information we can find regarding protein binding in animal and human studies. We can search for Enablex under the add drugs and drug classes tab by searching under the “A-Z” tab. We go under “E” and we can find “enablex” here. We add this and we can rightaway select for protein binding data. Let’s narrow the search down to plasma protein binding and then click search. Now we can see that the results can be sorted by species. We can see that there is data present for studies done in dogs, humans, rabbits and rats. We can see that there is a lot of plasma protein data present. By looking at this data, we can see that we can gain some interesting insight. For one, if we look at results 5 & 6, we can see that by increasing the dose by 5x, the plasma protein binding does not significantly change in dogs. However, if we look at lines 10 & 11, we can see that by increasing the dose by up to 5x, the plasma protein binding changes by greater than 90%! This can in part explain why adverse events were seen at higher doses. And this is an example of how PP can significantly influence the way in which you design your preclinical studies.
Besides finding a drug using the method I showed before, we can also go under the general search tab and type the drug of interest. So if we type Aromasin in the search bar, we can then directly click on the pharmacokinetics data link. Now here, because we are looking for all pharmacokinetic data, we will see the preclinical and clinical view. Under the preclinical tab, let’s filter and look at bioavailability data. If we click on show filters tab and click “absorption” and then click on bioavailability, we can see how in dogs and rats, the bioavailability is hovering under 5%. If we now do the same thing on the clinical data tab, we can see that the data is drastically different and the parameter value is actually 86%. This is an example of how having the PK module in PP can really help you mitigate risk when planning your preclinical studies. If you click on the second result, you can see from where they got the data, and in addition, you can find additional interesting information from there.
Here you can see that if we look at the study group and scroll down, we can actually see ethnic differences for bioavailability with Japanese groups having a higher bioavailability than caucasions. Could be a very interesting thing to know if you are looking to penetrate different markets with your drug. This kind of comparative data can really make a big difference!
We go under drugs and drug classes, and we can as an example click on cholinesterase inhibitors. We click add. We can then expand the PK parameters and go under biotransformation and see what %age of the drug dose in transformed into metabolites. Click on metabolic transformation and then “search now” and then we can see all of the relevant data. Look at donepezil hydrochloride and see how you can get extra information when you click on the link in regards to studies done on dogs. Now if we go back, we can see what the data is like in humans. If available, we can even see the metabolite of interest in the parentheses. If we scroll a little bit and look at the data provided in this table, we can actually see that the metabolite “o-glucuronides” is present in both dogs and rats, but possibly not in humans suggesting perhaps a species specific metabolite which would be interesting to know upfront without having to spend too much time wondering if this is something that you need to maybe worry about in humans.
As an example, let’s look at the drug Acebutolol Hydrochloride or Acebutolol. Again we click on the PK tab and now we can for example go under clinical data and find some interesting data in humans. We can filter by clicking on absorption, and then on concentration, and then we can actually select for Cmax. As a side note, we can actually see that this data is from 1984, and this data would actually be present in the classic collection of PP which has data from 1938 till 1991 inclusive. This could be interesting info if, for example, you are looking at PK data for repositioning this drug on the market. So from looking at this data, we can actually see that by doubling the dose, we can also almost double the Cmax value. Now if we click, on let’s say the 3 rd result because it actually also shows us data on the metabolite, we can actually see that it gives us further interesting information. It actually says that “the study demonstrated that although non-fasting conditions resulted in a decrease in the rate and the peak levels of acebutolol absorbed and metabolized by these healthy volunteers, there was no significant difference in the actual bioavailability. And here is a table which shows further info. Obviously some very interesting comparative data here for drug development studies.
As I scroll down you can see all of the interesting data that is available. Now it is pretty straightforward to see all of the data that is available. But let’s see if we can find an example of some interesting data we can find with combinatorial drugs. If we scroll down, we can see data on a combinatorial administration of acetaminophen, asprin and caffeine. Here you can see that you have the doses of all three substances listed here. Now if we click on the link to go straight to the document, we can see the wealth of data that is present in the document itself. It actually presents data in comparison to different forms of the drug, tablet, caplets and geltaps. And you can actually see at the end after scrolling through all this data that the concentrations of the combinatorial drugs is not affected by extra strength acetaminophen which is Excedrin. This data can be really useful if for example you are doing similar combinatorial drug studies. This data can potentially be cited and could maybe help you avoid repeating studies which can save you a lot of time and money. Now let’s see if we have time to go through one more example. Let’s quickly go back and scroll down a bit further till we get to this result where again we see combinatorial drug administration. However here, under Tmax, we actually see them mention a metabolite. If we click on the link and scroll down to the Pharmacokinetic section, we can actually see that there is a difference in PK profiles of tramadol but not acetaminophen when administered together. (see second line of paragraph under the table and the last line). Acetaminophen affects the PK profile of tramadol and the metabolites, but not vice versa. Could be some very interesting data to keep in mind when doing drug development studies. And also something to keep in mind is that this data where we see one drug being affected by acetaminophen is different from the previous example I showed where acetaminophen did not significantly affect the PK profiles of the other combinatorial drugs. Hence being fully informed on the comparative data which can be available to you is critical in order to properly plan out your preclinical and clinical studies.