The Premier Consulting Blog

MAY 4, 2023

The new guidance provides detailed information to applicants and manufacturers regarding compliance with the requirements in 21 CFR Part 4 for ophthalmic drugs packaged with eye cups, eye droppers, or other dispensers.

FDA 52

FDA Packaging Regulations Compliance 52

The Premier Consulting Blog

NOVEMBER 8, 2022

Determining if you have a combination product The high-level definition of combination product seems straightforward: a product with at least two constituent parts, such as: Drug/biologic (e.g., metered-dose inhaler) However, the four-part definition in 21 CFR 3.2(e) The drug product is packaged and shipped as a solid powder.

Production 52

Production Efficacy & Potency Packaging FDA 52

Perficient: Drug Development

DECEMBER 30, 2024

Building a pipeline includes the following major steps: Create a build definition Install NodeJS Restore npm packages Build the solution Package the solution Prepare the Artifacts Publish the Artifacts Create a Build Definition Build definition contains the definition and configuration for the build.

Packaging 52

Packaging Production 52

Perficient: Drug Development

AUGUST 29, 2023

We will dive into creating a BDD Feature file and Step Definition file in Katalon Studio for a test case and perform execution of the test by two methods: Directly running the Feature file and utilizing in-built Keywords to run it from the Test Case. This article will explore how we can perform BDD testing in Katalon Studio.

Packaging 52

Packaging 52

Practical Cheminformatics

JANUARY 8, 2024

When given the prompt “Please estimate the binding affinity between the drug Afatinib and target EGFR”, GPT-4 suggested a docking study, which is definitely not a wise choice. These fingerprint bits then map to atom environments or bond paths, which often don’t correspond to widely accepted functional group definitions.

Drugs 141

Drugs Small Molecule Bioinformatics Packaging 141

Perficient: Drug Development

SEPTEMBER 25, 2023

Hey Sitecore professionals, if you have not heard about Sifon for Sitecore – you must definitely check this out. I spent a lot of time building and testing it and can say Sifon is a definite Swiss army knife for local Sitecore development in the right arms, so you’d really like to learn why. Just one click to it.

Packaging 52

Packaging Licensing Licensing 52

Perficient: Drug Development

AUGUST 8, 2023

Create the Component definitions ( Rendering and Placeholder settings ) in Sitecore using the JSS CLI: jss deploy component Form --allowedPlaceholders jss-main We can change the allowed Placeholder to the placeholder name you want to allow the form to be added to. Create a Form Rendering for the JSS App. application.

Packaging 98

Packaging 98

Perficient: Drug Development

DECEMBER 26, 2023

Kubernetes Testing Approaches Unit Testing: Definition: Unit testing is a software testing approach that focuses on evaluating individual components of a system in isolation. End-to-End Testing: Definition: End-to-end testing is a comprehensive testing approach that evaluates the entire application, including its dependencies.

Packaging 52

Packaging Production 52

Perficient: Drug Development

JUNE 27, 2023

Getting Started with PropTypes: To begin using PropTypes, you need to install the prop-types package, which is already included in most React projects. This not only improves code quality but also enhances the debugging process by providing clear error messages when incorrect data types are passed.

Packaging 52

Packaging Production 52

Perficient: Drug Development

MAY 21, 2024

For example: Type Definitions for External Libraries: If you’re using third-party libraries that don’t have built-in typescript support, you can create type definitions for them using. files or by installing community created definitely typed packages. Within a Next.js

Packaging 52

Packaging Production 52

Agency IQ

FEBRUARY 23, 2024

An AgencyIQ explainer on the EPA’s definition of PFAS may be reviewed here.] In the same month, the California Department of Toxic Substances Control (DTSC) presented its chemical profile for carpets and rugs containing PFAS as well as a webinar for its findings on PFAS in food packaging.

Packaging 40

Packaging Regulations Production Compliance 40

Advarra

JULY 19, 2022

Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting? A: The FDA’s guidance document indicates the briefing package is submitted four weeks before the meeting. Q: What is the definition of a drug? A: This is a complex topic and is best outlined in the FDA’s guidance document.

Packaging 52

Packaging FDA Trials Regulations 52

The Pharma Data

MAY 13, 2021

And why instead, by taking action today and selecting one of the packages you see below…. By clicking on one of the packages you see beneath this video right now…. Once you’ve selected your package of Spade SB-66… You’ll be taken to our 100% encrypted and secure checkout page…. And actually, that’s still just the start.

Packaging 52

Packaging Production International Science 52

Agency IQ

MARCH 15, 2024

Background: SB 54 and its requirements On June 30, 2022, Governor Gavin Newsom signed into effect SB 54, the Plastic Pollution Prevention and Packaging Producer Responsibility Act. Cutting waste: By 2032, SB 54 requires that the state cut the use of single-use packaging and food service ware by 25%.

Regulations 40

Regulations Packaging Compliance Production 40

FDA Law Blog: Biosimilars

JUNE 12, 2023

Moreover, ingredients used in pet food must be approved by FDA, affirmed or listed as Generally Recognized as Safe (GRAS) by FDA, or go through the AAFCO definition process. PFI’s president has stated that “[t]he biggest issue is the inconsistency in state interpretation of AAFCO label definitions.

Regulations 45

Regulations FDA Production Government 45

FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Another rejected proposal was a definition of “vaccine” (vaccines are exempt from Medicaid rebates), which would have limited this term to a product that is administered prophylactically – i.e., to prevent rather than treat a disease. that is not supported by the statute and applicable regulations.” 1396r-8(k)(3).

Drugs 59

Drugs Regulations International Production 59

Perficient: Drug Development

NOVEMBER 8, 2023

and npm (Node Package Manager) by running the following commands in your terminal. file for route definitions and an index.js 5) node modules Directory: All the project’s dependencies and packages are stored in this directory, typically managed by package managers such as npm or Yarn. version 10.6.0 Once Node.js

Packaging 52

Packaging Production 52

Practical Cheminformatics

DECEMBER 4, 2022

In addition, the core code for extracting ring systems from molecules has been incorporated into the latest version of my pip installable useful_rdkit_utils package. Unfortunately, this definition quickly collapses when considering a system such as pyridone. The code accompanying this post is in a Jupyter notebook on GitHub.

Packaging 52

Packaging Clinical Trials Production Drugs 52

Agency IQ

AUGUST 25, 2023

Manufactured since the 1940s, their carbon-fluorine bond tends to be the hallmark of a PFAS (though there is no common definition). As such, they can be found in myriad applications ranging from raincoats, refrigerants, and lubricants to non-stick pans, food packaging, and semiconductors. s PFAS restriction proposal.]

Regulations 40

Regulations Government Packaging Organic Chemistry 40

Perficient: Drug Development

DECEMBER 17, 2023

Dependency Management with Maven or Gradle Introduction to Build Tools In the realm of Spring Boot development, build tools play a crucial role in managing dependencies, compiling source code, and packaging applications. Then maven package option. Two popular build tools in the Java ecosystem are Maven and Gradle.

Packaging 52

Packaging Production 52

The Premier Consulting Blog

MAY 11, 2023

The guidance provides information to biopharma manufacturers regarding ophthalmic drugs packaged with eye cups, eye droppers, or other ophthalmic dispensers, where those articles meet the device definition. All regulated parties, including ophthalmic drug and device manufacturers, should take note.

FDA 52

FDA Compliance Regulations Production 52

The Premier Consulting Blog

OCTOBER 11, 2022

During that meeting, the sponsor presented data by endpoint, which complemented the data package and indicated the benefits of treatment outweighed the risks. The agency encouraged further review of the data for potential reference as a historical control. The FDA also granted a second meeting for review.

Disease 52

Disease FDA FDA Approval Treatment 52

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Here, the draft guidance states that the appropriate timing for an INTERACT meeting should be when a sponsor has identified a specific product and has conducted some preliminary proof-of-concept (POC) studies but has not yet designed and conducted definitive toxicology studies.

Therapies 59

Therapies FDA Production Disease 59

Agency IQ

JULY 8, 2024

It also proposed several packaging changes to safeguard against misidentification. Medical gases were one of several topics during the deliberations that led up to the passage of the final legislative package, which was known as the Food and Drug Administration Safety and Innovation Act (or FDASIA).

FDA 40

FDA Regulations Production Packaging 40

Agency IQ

SEPTEMBER 15, 2023

Although there are several different definitions of what a PFAS is, the class contains thousands of different chemicals. In the same month, the California Department of Toxic Substances Control (DTSC) presented its chemical profile for carpets and rugs containing PFAS as well as a webinar for its findings on PFAS in food packaging.

Regulations 40

Regulations Packaging Production Organic Chemistry 40

Perficient: Drug Development

JULY 25, 2023

Error on publish: Ensure definition type did not complete successfully. This involved comparing files that are included in the WDP package for Azure and Solr and disabling/enabling them. The xConnect Roles were set up initially with Azure Search using WDP templates and Solr Cloud set up is also part of this exercise.

Packaging 52

Packaging Production International Marketing 52

The Pharma Data

NOVEMBER 22, 2020

Distributing the vaccine under ultra-cold chain storage conditions, she said, “is possible, but it’s definitely going to be much more expensive and more difficult.”. Pfizer has designed its own packaging using dry ice that can be stored for weeks without the specialized freezers.

Vaccine 52

Vaccine Virus Trials Regulations 52

Agency IQ

SEPTEMBER 15, 2023

California’s definition of ingredient is the same as defined at the federal level which is, any single chemical entity or mixture used as a component in the manufacture of a cosmetic product ( 21 CFR 700.3(e) A definition of the term “hold” is absent from both of these bills.

Regulations 40

Regulations Packaging Production Government 40

Agency IQ

MAY 10, 2024

Recently introduced legislation North Carolina: On May 1, 2024, North Carolina State Representative JOHN AUTRY introduced HB 973 , a bill to ban intentionally added PFAS in food packaging. However, Maine (and some other states) have more broadly focused on banning all intentionally added PFAS in products after a certain date.

Packaging 40

Packaging Regulations Production Compliance 40

The Pharma Data

SEPTEMBER 7, 2021

The Chinese package insert notes that the safety of KEYTRUDA plus chemotherapy was investigated in 51 Chinese patients with esophageal carcinoma in KEYNOTE-590, and the safety profile of the Chinese patients was generally consistent with the known safety profiles of KEYTRUDA monotherapy and chemotherapy. The median PFS was 6.3

Treatment 52

Treatment Research Laboratories Packaging Laboratories 52

Perficient: Drug Development

MAY 6, 2024

This is definitely a good use case for Conscia. Let’s (re)package up the first three capabilities into a larger topic – stay tuned for part 4 where we will talk about Digital Experience Composition (DXC). to the actual content and data to hydrate those experiences. Let’s better understand the differences here.

Engineering 59

Engineering Production Packaging International 59

Translation

JULY 9, 2024

Ashish Basuray Kevin Leland: So, Ashish, first off, can you tell us your definition of a tech landscape? Kevin Leland: Do you find that these tech landscapes are any materially different whether you’re talking about packaging, gene therapy, or women’s health, for example, or do they all follow the same format?

Packaging 52

Packaging Science Marketing Therapies 52

Perficient: Drug Development

APRIL 4, 2024

<script src="[link] <script src="[link] You can also leverage package managers like NPM to manage your project dependencies more efficiently. Each route definition consists of a URL path, a template URL, and, optionally, a controller. routeProvider.js We configure routes using the `$routeProvider.when()` Method.

Production 52

Production Packaging Engineering 52

Agency IQ

AUGUST 4, 2023

Definitions from the existing E.U. These features should not be included on outer packaging or immediate packaging, if there is no outer packaging. only” labelled packages can only be released into the market beginning January 1, 2025, and not earlier. only” label can be affixed anywhere on the packaging.

Packaging 40

Packaging Licensing Licensing Regulations 40

Perficient: Drug Development

AUGUST 28, 2023

Once the crx-quickstart/logs/stdout.log file prints “Startup Completed”, install the latest service pack via package manager. To optimize performance, I looked at the slowest JCR queries and then used the Oak Index Definition Generator to define custom indexes. Wait another hour and then restart.

Packaging 52

Packaging 52

The Pharma Data

JANUARY 17, 2021

It received FDA guidance January 5 th and is in the midst of preparing the first package of investigational new drug (IND) applications – usually with an n-of-1, for individual patients. We are looking forward to more definitive guidance in the coming months.”. Patient dosing is expected to begin later this year. “No Source link.

Disease 52

Disease Clinical Trials Small Molecule Treatment 52

Perficient: Drug Development

FEBRUARY 28, 2024

In the new Client Library definition, we give the categories name which is called ‘core.wcm.components.teaser.v2.gpt.editor3’ Below is the source code of the Java class for the configuration definition. xml version="1.0" encoding="UTF-8"?> emptyTextstring="Enter prompt for ChatGPT here" fieldLabel="Promps for ChatGPT" name=".

Packaging 52

Packaging Engineering International Research 52