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Performance Characteristics for Identification Tests: What’s Actually Required?
Performance characteristics are method validation parameters that help determine whether a test method is fit for its intended purpose....
bhaskar napte
Jul 252 min read
505(b)(2) vs. ANDA Suitability Petition: Navigating USFDA Regulatory Pathways for Modified Drug Products
Introduction When pharmaceutical companies look to bring modified versions of existing drugs to market—whether it's a new strength,...
bhaskar napte
May 274 min read
Defining Specifications for Known and Unknown Impurities in Drug Substance
The ICH Q3A guideline provides a clear regulatory framework for managing impurities in drug substances. It introduces three critical...
bhaskar napte
May 263 min read
Understanding the Differences Between 505(j), 505(b)(1), and 505(b)(2) Drug Approval Pathways
When bringing drugs to the U.S. market, pharmaceutical companies have different regulatory pathways to follow based on the nature of the...
bhaskar napte
Nov 4, 20243 min read
Common Mistakes in Dossier Preparation and How to Avoid Them
This quick guidance will help you to avoid mistakes in dossier
bhaskar napte
Sep 6, 20247 min read
Overview of Common Technical Document (CTD)
Introduction The Common Technical Document (CTD) is an internationally recognized standard used for submitting applications to regulatory...
bhaskar napte
Sep 1, 20243 min read
Investigational Medicinal Product Dossier (IMPD)
Introduction to the Investigational Medicinal Product (IMP) An Investigational Medicinal Product (IMP) refers to a pharmaceutical form of...
bhaskar napte
May 11, 20242 min read
Biologics & Biosimilar and their approval process in US
Biologics have transformed the treatment landscape for numerous diseases, including cancers, autoimmune disorders, and chronic...
bhaskar napte
May 6, 20242 min read
Exploring Career Opportunities in the Pharma Industry: A Comprehensive Guide
The pharmaceutical industry offers a wealth of career opportunities that go beyond the traditional roles commonly associated with...
bhaskar napte
May 5, 20244 min read
EU Drug Approval Process
Introduction: The EU drug approval system includes several routes that pharmaceutical companies can utilize to get their products...
bhaskar napte
Apr 30, 20245 min read
The Journey of Drug Discovery to Commercialization in EU
Introduction The pharmaceutical landscape in the European Union (EU) is a complex and regulated environment where new drugs undergo a...
bhaskar napte
Apr 30, 20242 min read
Classification of Hygroscopicity
Hygroscopicity: Hygroscopicity refers to the ability of a substance to absorb moisture from the environment. In the context of...
bhaskar napte
Mar 7, 20241 min read
A Look Into the Working Standards of the Pharmaceutical Industry
How to qualify working standard
bhaskar napte
Dec 7, 20234 min read
Why You Must Avoid Highly Aqueous Mobile Phases When Using C8/C18 Columns?
This article delves into the challenges due to the usage of high aq. mobile phases in RPLC and offers solutions
bhaskar napte
Dec 6, 20233 min read
How to Select the Dimension of an HPLC Column?
Selecting the right HPLC column dimensions during HPLC method development
bhaskar napte
Dec 1, 20232 min read
How to reduce mobile phase consumption during an HPLC analysis
How to reduce mobile phase consumption during HPLC analysis
bhaskar napte
Nov 30, 20233 min read
Essential Precautions for HPLC Mobile Phase Handling and Use
This article will help you to solve the challenges related to mobile preparation and the use for your HPLC/UPLC analysis
bhaskar napte
Nov 28, 20233 min read
💥Effect of Triethylamine (TEA) on the Retention in RPLC
Impact of Triethylamine on Retention, and Peak Tailing in HPLC analysis
bhaskar napte
Nov 27, 20232 min read
Guidance on creating your new password by using the Forgot Password option
STEP 1: Visit www.pharmagrowthhub.com Click on the Log In tab (top right on the main menu bar) as shown below STEP 2: The next page as...
bhaskar napte
Nov 23, 20232 min read
What is the effect of free silanols in RPLC and how to reduce it?
Understand the silanol effect and way out to minimize it in RPLC
bhaskar napte
Nov 23, 20232 min read
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