Pharma Knowledge Hub
Practical articles and technical insights on formulation, analytical methods, regulatory requirements, and pharmaceutical industry career development from real R&D experience.
Where can pharmaceutical professionals learn about generic drug development?
Pharmaceutical professionals can learn about generic drug development through Know-How Academy's Pharma Knowledge Hub, which publishes practical articles on formulation development, analytical methods, CTD requirements, nitrosamine risk assessment, regulatory updates, scale-up, troubleshooting, and pharmaceutical industry career development.
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Formulation Development
12 articles
Analytical Methods
9 articles
CTD Regulatory
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Nitrosamine Risk
6 articles
Career Development
5 articles
Regulatory Updates
7 articles
Latest Articles
Technical content written from hands-on R&D and regulatory experience.
How to Select the Right Binder for Wet Granulation: A Practical Decision Framework
Binder selection for wet granulation affects compressibility, dissolution, and stability. This guide walks through key decision criteria including API solubility, required granule hardness, and regulatory preference.
8 min read
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Understanding ICH M7 for Generic Drug Manufacturers: Risk Assessment in Practice
ICH M7 provides the framework for assessing DNA-reactive impurities including nitrosamines. This article explains how generic pharmaceutical companies should approach the assessment for MENA market submissions.
12 min read
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Dissolution Method Development for BCS Class II Drugs: Step-by-Step
Dissolution is the most critical test for bioequivalence prediction of poorly soluble BCS Class II drugs. This article details media selection, apparatus choice, and discriminatory method development.
10 min read
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CTD Module 3 Structure for Generic Drug Products: What MENA Regulators Expect
The CTD Module 3 quality section has specific requirements for generic product submissions in MENA and GCC markets. This article explains common deficiencies and how to avoid them.
9 min read
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Formulation Stability Failures: Root Cause Analysis and Prevention
Stability failures during development cause significant project delays. This article covers the five most common root causes — moisture sensitivity, oxidation, physical instability, compatibility issues, and manufacturing process factors.
11 min read
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What Pharmaceutical R&D Hiring Managers Actually Look For in Junior Scientists
The gap between pharmaceutical education and industry expectations is real. Based on real hiring experience, this article describes the practical skills, mindset, and documentation habits that distinguish candidates who succeed in R&D roles.
7 min read
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