Advarra

AUGUST 21, 2024

Nowhere is this more painful than in clinical trials, the backbone of drug development. These complex studies typically generate hundreds or thousands of documents to share across clinical trial sites, pharmaceutical sponsors, physicians, patients, and regulators.

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Alta Sciences

OCTOBER 9, 2024

This document examines various analytical techniques that support pharmaceutical product development, with a focus on bioavailability. We take pride in developing, qualifying, and validating robust and rugged analytical procedures to ensure the quality of your products and meet the requirements of regulatory agencies worldwide.

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The Pharma Data

NOVEMBER 24, 2020

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more. There’s absolutely no risk to you.

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Fierce BioTech

SEPTEMBER 13, 2024

The new Guideline replaced the corresponding drug interaction guidance documents from the US FDA, EMA, and PMDA, among others.

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Chemical Biology and Drug Design

MAY 11, 2023

The results suggest that scFv-ACLP fusion proteins may be potential anticancer drug candidates for targeted cancer treatment. Abstract Antibody-directed drugs for targeted cancer treatment have become a hot topic in new anticancer drug development; however, antibody-fused therapeutic peptides were rarely documented.

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Quanticate

SEPTEMBER 2, 2024

One document which plays an essential role in the safety, traceability and overall validity of a clinical trial is the Statistical Analysis Plan (SAP). As a result, clinical trials must be performed to the highest degree of scientific and ethical standards, for results to be recognised as credible and the trial deemed as successful.

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The Premier Consulting Blog

JUNE 3, 2024

When properly defined, the TPP enables drug developers to manage the development equation of risk x cost x time = success, and it starts by keeping the end in mind. It is a core document that positions and differentiates a product. It articulates the unmet medical needs of patients, physicians, and payers.

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Perficient: Drug Development

OCTOBER 9, 2024

Accessibility considerations can impact several portions of the FDA submission process, including: Software Documentation : The FDA requires detailed documentation of the software development process, including usability testing.

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ASPET

OCTOBER 12, 2023

To maintain cadence with looming threats in a prolonged field care environment, the broader medical countermeasure (MCM) enterprise must adopt new strategies for CBRN-addressing drug development.

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Alta Sciences

NOVEMBER 15, 2024

4 Essential Topics to Cover in Your First CRO Meeting pmjackson Fri, 11/15/2024 - 19:22 Starting a partnership with a contract research organization (CRO) is a sometimes intimidating—yet exciting—first step in your drug development journey. IND, CTA, NDA, BLA). “If

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Conversations in Drug Development Trends

APRIL 4, 2024

Global Impact of ICH M10 Validation Guidelines Harmonization of bioanalytical validation methods is crucial in a world where pharmaceuticals are developed and approved across different regions. The ICH M10 guidelines aim to streamline this process, reducing redundancy in drug development and facilitating faster access to new therapies.

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Perficient: Drug Development

OCTOBER 25, 2024

It is important to note that a roadmap is an evolving document. Source: Facebook Insights from MITcon 2018 Source: Sample Agile Roadmap Template from Business Documents Why Use a Product Roadmap? What matters most is maintaining the document as a living reference, helping to guide and align the organization.

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Perficient: Drug Development

JUNE 25, 2024

Apache PDFBox is a versatile open-source library designed to work with PDF documents. It is widely used in various Java applications to create, modify, extract, and print PDF documents. Key Features of PDFBox PDF Creation PDFBox allows developers to create new PDF documents programmatically.

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Cytel

JUNE 2, 2023

Data submissions are very regulated, but every drug and drug development are different. Therefore, the data presented in the Common Technical Document (CTD) needs to be tailored to the specific submission.

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Perficient: Drug Development

MARCH 5, 2024

Every developer should be instructed to reference and update this document as implementation evolves. Work with your IT and cybersecurity team to thoroughly screen the original author to avoid any potential risks.

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The Premier Consulting Blog

NOVEMBER 12, 2024

For drug developers the 505(b)(2) pathway presents an expedited pathway to FDA approval. The 505(b)(2) developer may expect broader access and lower patient out of pocket cost (copay) than the payer is willing to give. De-mystifying the payer evaluation process of 505(b)(2)s A drug developer’s 505(b)(2) product is approved by FDA.

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Perficient: Drug Development

JUNE 25, 2024

To do this, utilize PDFBox, a Java library for managing PDF documents, in combination with Selenium, a potent web automation tool. It enables the creation, modification, and extraction of content from PDF files by developers. Key Features: PDF Creation: Enables the creation of new PDF documents from scratch.

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PPD

JUNE 10, 2024

This update reflects the integrated and expansive approach we bring to your drug development journey. As a part of Thermo Fisher, we bring you an expanded portfolio of offerings across all phases of drug development. It’s a visual representation of our enhanced capabilities and integrated solutions.

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Agency IQ

JUNE 9, 2023

FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity Late last week the FDA released a final guidance document containing recommendations on the nonclinical assessment of potential immunotoxicity for drugs and certain biologics. What are nonclinical studies and when are they conducted in drug development?

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Fierce BioTech

APRIL 4, 2024

Discover how leading organizations leverage AI to revolutionize operations and expedite drug development, ensuring faster access to life-saving treatments. Ensure regulatory compliance through efficient management of documentation, audits, and reporting, powered by AI automation.

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Advarra

DECEMBER 14, 2023

Sites working with an investigational new drug (IND) are often subject to an FDA site inspection. Through the inspection, any potential violations of the FDA’s requirements are documented in a Form FDA 483 as observations, also called findings or citations. Documents should be well named and always up to date on the current version.

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PPD

OCTOBER 17, 2024

This expansion represents a significant opportunity for both drug developers and patients, while also presenting a new and diverse set of challenges for drug developers, particularly in clinical trial execution. They also need to have the medical competencies to manage adverse events often associated with these therapies.

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Fierce BioTech

OCTOBER 26, 2023

Efficient clinical pharmacology review of a marketing application requires early and thoughtful consideration of the development plan, timely conduct of necessary clinical studies, maximizing available clinical data using model-informed drug development (MIDD) approaches, and expert communication of integrated information.

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FDA Law Blog: Biosimilars

OCTOBER 13, 2024

We have heard over and over again how the potential for a priority review voucher has allowed small companies with limited resources to invest in the development of drugs for rare pediatric diseases. We heard and felt the anxiety from many of our clients about the uncertainty this caused. After all, this is what incentives are for.

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Alta Sciences

OCTOBER 7, 2024

During the early stages of drug development, fully characterizing the active pharmaceutical ingredients (APIs) is crucial for optimizing the drug product formulation. Robust analytical testing , selecting the right methods, and documenting results with precision is paramount. WHAT IS THE ALTASCIENTIST?

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Pharmaceutical Development Group

DECEMBER 19, 2021

Effective use of Real World Data (RWD) and Real World Evidence (RWE) can reduce costs of Pharmaceutical Drug and Biologic Products and Process Development, Drug Development Services , expedite a FDA Pre-Submission Review, and lead to FDA Approval. Author Information William E. Spanogle, Ph.D.

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FDA Law Blog: Drug Discovery

MARCH 7, 2024

Other Oversight Groups Both documents described the role of other oversight groups, in addition to DMCs, that may be involved in a clinical trial in similar, sometimes overlapping, roles such as IRBs, trial steering committees, and site monitors. Increased Connections Between a DMC and FDA?

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Perficient: Drug Development

NOVEMBER 6, 2023

The Internal ChatGPT proof of concept was developed on Azure’s OpenAI chat interface. It enables employees to retrieve information from various documents and databases within a company’s internal network. This eliminates the need for manual searches through multiple documents, saving valuable time for employees.

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International Regulations Production 64

Perficient: Drug Development

APRIL 1, 2024

In the Optimizely Search & Navigation admin view, administrators can set a certain weight of different properties (title, content, summary, or document content). According to the documentation, “The default property weight, 1, does not affect the score. And the boost weight of that matching condition is 2.

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Perficient: Drug Development

DECEMBER 12, 2023

Create the vectors that ACS will use to search through the documents using the OpenAI Embeddings class. To load the documents and the vectors to ACS, you need to have an Azure account and a search service. This method takes a list of documents as input and uploads them to ACS along with their vectors.

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Engineering 52

Perficient: Drug Development

SEPTEMBER 3, 2024

With Edge Delivery, you can choose from two flexible implementation options – document-based authoring and WYSIWYT (What You See Is What You Get) – to streamline your development workflow and accelerate content authoring. Example block folder structure.

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KIF1A

JANUARY 13, 2024

Aditi Falnikar’s presentation from our 2023 KAND Conference Read the Article Rare Roundup FDA issues final guidance on rare disease drug development As we continue to explore new therapeutic avenues for treating KAND, it is crucial to think about the regulatory steps those therapies will face.

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The Premier Consulting Blog

NOVEMBER 12, 2023

There have been multiple guidance documents aimed at providing industry oversight of regulatory activities related to AI/ML-enabled devices since the release of these action plan. Providing consultations for drug submissions that involve AI/ML-based devices to help ensure that these submissions meet regulatory requirements.

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Perficient: Drug Development

MAY 27, 2024

Define clear and concise documentation that outlines the API’s functionality, required parameters, and expected responses. Publish the documentation internally or externally to make it available to the API consumers. For more information, you can visit documentation.

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Perficient: Drug Development

OCTOBER 26, 2023

Since I referred to various online sources to execute this, I’ve documented the process below. While the documentation suggests creating or overwriting an icon pack to implement a custom icon (refer to: [link] ), I discovered that the method outlined below also works if you simply want to add a single icon other than an SVG.

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Perficient: Drug Development

NOVEMBER 7, 2023

This implies that the document count for a given index, such as ‘sitecore_web_index,’ differs across each replica node. Confirm the Document Counts To confirm the issue of ‘document counts not being in sync among replica nodes,’ we logged in to the Solr dashboard of the affected environment.

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PPD

NOVEMBER 9, 2023

However, over the past decade, a trend toward incorporating multiple study populations into one protocol has slowly gathered momentum among drug developers. Improved prioritization Promising pipeline candidates with a strong early development protocol may see a positive impact to the net present value of an early-stage asset.

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