Impact Pharmaceutical Services

MAY 4, 2022

In May of 2014 and February of 2019 , the FDA released final Guidance for Industry outlining the Agency’s policies and procedures regarding expedited development and review programs for new drugs and biologics intended to treat serious or life-threatening conditions. Category: Regulatory Affairs , Drug Development Consulting.

FDA 52

FDA Documentation Communication 52

Roots Analysis

NOVEMBER 3, 2023

NAMPT inhibitors are a class of drugs that target the enzyme nicotinamide phosphoribosyltransferase (NAMPT). One of the main challenges is the development of drug resistance, as cancer cells can develop mechanisms to bypass the inhibition of NAMPT. Several trials focused on evaluation of such drugs were discontinued in the past.

FDA 40

FDA 40

ISPE

JULY 10, 2023

But can we imagine applying a tool like ChatGPT in a safety-critical, product-related environment? ChatGPT : “Yes, ChatGPT can be useful in regulated areas of the pharmaceutical industry, such as providing information on drug products, their uses, dos-ages, side effects, and interactions with other medications. The Keyword.

Labelling 52

Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

IDStewardship

MARCH 17, 2024

Pharmacists aim to ensure medication safety and efficacy—a goal that involves diverse tasks across different settings, often requiring skills beyond traditional pharmacy knowledge. Drug references & literature review AI is transforming the pharmacists’ approach to essential tasks like using drug references and literature reviews.

Documentation 336

Documentation Patient Care 336