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...
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bhaskar napte
Sep 67 min read
Common Mistakes in Dossier Preparation and How to Avoid Them
This quick guidance will help you to avoid mistakes in dossier
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bhaskar napte
Sep 13 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...
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bhaskar napte
May 112 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...
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bhaskar napte
May 62 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...
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bhaskar napte
May 54 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...
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bhaskar napte
Apr 305 min read
EU Drug Approval Process
Introduction: The EU drug approval system includes several routes that pharmaceutical companies can utilize to get their products...
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bhaskar napte
Apr 302 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...
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bhaskar napte
Mar 71 min read
Classification of Hygroscopicity
Hygroscopicity: Hygroscopicity refers to the ability of a substance to absorb moisture from the environment. In the context of...
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bhaskar napte
Dec 7, 20234 min read
A Look Into the Working Standards of the Pharmaceutical Industry
How to qualify working standard
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bhaskar napte
Dec 6, 20233 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
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bhaskar napte
Dec 1, 20232 min read
How to Select the Dimension of an HPLC Column?
Selecting the right HPLC column dimensions during HPLC method development
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bhaskar napte
Nov 30, 20233 min read
How to reduce mobile phase consumption during an HPLC analysis
How to reduce mobile phase consumption during HPLC analysis
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bhaskar napte
Nov 28, 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
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bhaskar napte
Nov 27, 20232 min read
💥Effect of Triethylamine (TEA) on the Retention in RPLC
Impact of Triethylamine on Retention, and Peak Tailing in HPLC analysis
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bhaskar napte
Nov 23, 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...
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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
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bhaskar napte
Nov 22, 20232 min read
Residual Solvents and Elemental Impurities: Classification & Exposure Limits as per ICH Q3C AND Q3D
Comparison between Residual Solvents and Elemental Impurities for Classification & Exposure Limits as per ICH
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bhaskar napte
Nov 21, 20233 min read
What are the probable reasons for the increase in assay during the stability study of a drug product
quick reference for probable reasons for increase in assay during stability study for a drug product
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bhaskar napte
Nov 20, 20232 min read
How to Access Courses on Mobile Phone
Congratulations on being part of the Pharma Growth Hub! Please check your inbox. You must have received several emails from...
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