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Certara Tools for Drug Development – PML, Phoenix, and Regulatory Data
New Horizons in Pediatric Drug Development - Day 2 - Opening Remarks

New Horizons in Pediatric Drug Development - Day 2 - Opening Remarks

Certara Tools for Drug Development – PML, Phoenix, and Regulatory Data

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جميع الدروس
102 درس
02:54 Certara.R School - Lesson 12: History and Advantages of the PML Language
01:22 Pinnacle 21 Enterprise
47:51 Unlocking Efficiency and Quality: What is New in Phoenix™️ 8.4?
23:10 What’s New for SEND 2023 Webinar
22:54 AI in Healthcare Today – Dell Technologies & Certara
01:34 Vyasa Layar Explainer
44:45 Certara SEND Webinar Series Session #1
00:16 FDA Modernization Act 2.0 – What does it mean for drug developers?
41:59 D360 as your organization’s extendable and central data engine
57:48 Machine learning model selection with Darwin in Pirana
56:19 Learn how Certara’s Integral streamlines PK/PD workflows
35:46 Learn how to leverage the power of cloud computing to streamline your workflow!
00:06 Learn how to create CDISC domains in minutes with PK Submit
55:19 How to Define & Measure Clinical Endpoints to Optimize Your Oncology Drug Dosing
57:48 Learn how to leverage the power of cloud computing to streamline your workflow!
42:26 Phoenix WinNonlin Secure
42:09 Learn how to shorten the drug discovery design-make-test-analyze cycle with D360
35:27 Learn how to save valuable time on PK/PD analysis and modeling with Certara’s Phoenix Platform
40:25 Learn how to streamline PK/PD workflows with Certara’s Integral Data Repository
48:01 Learn why Phoenix is the industry gold standard for PK/PD analysis
31:44 eChalk Talk: How Oncology Drug Developers Can Prepare for FDA’s Project Optimus
01:22 BaseCase Video Control Demo
48:46 Learn how Integral streamlines PK/PD workflows & ensures compliance with regulatory requirements
04:07 1. Phoenix Screen Resolution
01:08 Improved Workflow and Expanded Functionality of RsNLME - Version 1
54:26 What Oncology Drug Developers Should Expect from the FDA’s Project Optimus
11:29 Predicting and Taming Immunogenicity: Overview of Immunogenicity & ADA Assays
06:24 Predicting and Taming Immunogenicity: What is an Integrated Summary of Immunogenicity (ISI)?
08:08 Predicting and Taming Immunogenicity: Complex Biologic Considerations
13:11 Best Practices in Data Programming: A Chat with Susan Potts
07:04 The TOGETHER Study Shows that Fluvoxamine Reduces Risk of Prolonged Hospitalization
05:05 Predicting and Taming Immunogenicity: Strategies for your Biologic Drug
45:39 Learn How Discovery Data Technology Enables Faster Discovery Research
44:56 New Horizons in Pediatric Drug Development - Day 2, Session 2 - Panel Discussion
12:53 New Horizons in Pediatric Drug Development - Day 2, Session 3
25:21 New Horizons in Pediatric Drug Development - Day 2, Session 3 - Panel Discussion
18:52 New Horizons in Pediatric Drug Development - Day 2, Session 3
13:14 New Horizons in Pediatric Drug Development - Day 2, Session 3
19:29 New Horizons in Pediatric Drug Development - Day 2, Session 2
23:01 New Horizons in Pediatric Drug Development - Day 2, Session 2
20:17 New Horizons in Pediatric Drug Development - Day 2, Session 2
14:57 New Horizons in Pediatric Drug Development - Day 2, Session 1 - Panel Discussion
19:11 New Horizons in Pediatric Drug Development - Day 2, Session 1
14:57 New Horizons in Pediatric Drug Development - Day 2, Session 1
01:38 New Horizons in Pediatric Drug Development - Day 2 - Opening Remarks
20:51 New Horizons in Pediatric Drug Development - Day 1, Session 2 - Panel Discussion
17:53 New Horizons in Pediatric Drug Development - Day 1, Session 2, Part 2
21:51 New Horizons in Pediatric Drug Development - Day 1, Session 2, Part 1
46:02 New Horizons in Pediatric Drug Development - Day 1, Session 2 - Panel Discussion
17:18 New Horizons in Pediatric Drug Development - Day 1, Session 1, Part 2
12:57 New Horizons in Pediatric Drug Development - Day 1, Session 1, Part 1
16:46 New Horizons in Pediatric Drug Development - Day 1 Q&A
32:25 New Horizons in Pediatric Drug Development - Keynote
03:11 New Horizons in Pediatric Drug Development - Day 1 - Introduction & Welcome
25:13 Better Together: An Interview with Patrick Smith, Raj Bhardwaj, and Mayumi Hasegawa
41:27 What does the Clin Pharm Plan for a Biologic Look Like?
55:38 Pharmacometrics & Clinical Pharmacology FOMO: Why the Future of Research is in Africa
00:53 When you have a spot, get your spot!
01:00 Your First Choice in Complex Biologics Drug Development
56:56 The Wizard of Oligos: There’s no place like having a successful drug development program!
44:17 The Promises and Pitfalls of Gene Therapy for Rare Diseases
55:27 Sealing Pharma Commercialization Deals: Creating Optimal Value for Investors
06:17 Best Practices for oligonucleotide therapeutic development: Q&A
25:20 Oligonucleotide therapeutic development: Clinical pharmacology considerations
25:00 Oligonucleotide therapeutic development: Pre-clinical and translational considerations
09:25 What are oligonucleotide therapeutics, and how do they work?
05:50 Expert Tips for Pediatric Drug Development and Regulatory Success
26:49 Getting the Dose Right for COVID-19 Vaccines
07:07 Submerge in the Oligonucleotide Emerge: Best Practices for Developing These Complex Biologics
43:01 How to Accelerate COVID-19 Vaccine Development with Biosimulation
52:55 Enhance Your Drug Development Capacity with Clin Pharm Study Execution & Operational Support
57:46 Model-based meta-analysis for comparative efficacy and safety of therapeutics for COVID-19
02:36 Making your drug program investor-ready
24:29 Avoid these common mistakes to secure a deal
04:41 An Introduction to Asset Evaluation
33:59 The Role of MIDD in Drug Development for COVID-19
59:51 Juvenile toxicity studies considerations – not just “mini” general tox!
02:57 Supporting the global approval of an antiviral drug for infants
53:51 Intro to Smart In Silico Tools to Aid in Translating In Vitro & In Vivo Studies
02:04 Accelerating Medicines & Vaccines Using Virtual Patients
02:46 Solving a Mystery Using PBPK: How Drug-excipient Complexes Can Confound a Metabolic DDI Result
02:53 CODEx Demo
00:54 Fostering Pediatric Oncology Drug Development
19:05 Accelerating Therapeutics for COVID-19: Dr. Craig Rayner
02:06 D360 Overview
02:53 Accelerating Vaccine Development: Applications to COVID-19 and Future Pandemics
18:30 HIV Déjà Vu? Optimizing Cocktail Therapies for COVID-19
48:46 COVID-19 Therapeutic Considerations for Children and Pregnant Women
03:19 Team Certara - Let's Beat COVID Together
57:48 Pharmacology to Payer: One Quantitative Drug Development Framework to Rule Them All
52:49 Using PK/PD M&S for Pediatric Drug Development: Regulatory Insights into Practical Issues
43:45 Found in Translation Building an Early Development Strategy for Complex Biologics
49:02 How Due Diligence Facilitates Successful Biotech Investments, Deals, and Partnerships
59:22 Application of Tracer Kinetics in Drug Development A Valuable but Underused Tool in Clinical Pharmac
02:07 A House Divided – The Interplay of Bioanalysis and Pharmacokinetics
56:16 Apocalyptic Clinical Pharmacology A Comprehensive Approach to Drug Development
03:16 Value Focused MIDD: Influenza Model-informed Drug Development Program
04:05 Value Focused MIDD: Respiratory Syncytial Virus (RSV) Model-informed Drug Development Program
03:13 Value Focused MIDD: Oncology Model-informed Drug Development Program
01:01 Town Level Agent Based Influenza Model
01:22 Influenza pandemic model of US
58:45 Best Practices in Clinical Pharmacology Gap Analysis