Insights

Vol. 2: Wow! The success rate of drug development is shockingly low!

2025.07.01
In the previous volume, we discussed the types of pharmaceutical medicines and patents, so you will remember that “new drugs” are brand drugs under the category of ethical drugs… 黒澤伸行

Insights

Vol. 1: First, let’s talk about medicine classification and patents

2025.05.30
Most people understand that patents are important in the life sciences industry, including pharmaceuticals and biotechnology. However, many might feel that the complexities of patents make them difficult … 黒澤伸行

Cleaning Validation

7-Part Series: Part 6 – Calculating MAC in Cleaning Validation

2025.06.12
Hello everyone. In this article, we will discuss how to calculate the Maximum Allowable Carryover (MAC), which plays a critical role in cleaning validation in the pharmaceutical industr… 黒澤伸行

Cleaning Validation

7-Part Series: Part 5 – Evaluating Cleaning Effectiveness: The Role of Swab Recovery Rate Testing

2025.05.26
This time, we will discuss the feasibility testing of swab recovery rates for compounds. This test is designed to verify the recovery rate of Total Organic Carbon (TOC) analysis when dealing w… 黒澤伸行

Cleaning Validation

7-Part Series: Part 4 – A New Approach to Cleaning Validation: The Effectiveness of TOC

2025.05.12
Cleaning validation in the pharmaceutical industry plays a critical role in ensuring that manufacturing equipment is properly cleaned and free from residues before the next production batch. Ho... 黒澤伸行

Cleaning Validation

7-Part Series: Part 3 – Cost Comparison Between TOC Analyzers and HPLC in Cleaning Validation

2025.04.14
Cleaning validation is a critical process in the pharmaceutical industry. Various analytical methods are used to confirm that manufacturing equipment is properly cleaned. Among these methods, Tot… 黒澤伸行

Cleaning Validation

7-Part Series: Part 2 – Cleaning Validation in the Pharmaceutical Industry: Importance of Analytical Method Validation for TOC

2025.04.01
In this article, we introduce analytical method validation for TOC in cleaning validation for the pharmaceutical industry. This innot… 黒澤伸行

Cleaning Validation

7-Part Series: Part 1 – The Cutting Edge of Cleaning Validation: An Efficient Approach Utilizing TOC

2025.03.18
In the pharmaceutical industry, cleaning validation is a critical quality control process that requires strict compliance with regulatory authorities. This series covers a wide range of practical topi… 黒澤伸行

Columns

Issue No. 7: Baseline Research and Biomarker Exploration

2024.07.18
It is believed that it will take at least 10 years for the drugs currently under development to begin practical use. By then, the overall healthcare system surrounding drugs is expected to differ significantl… 黒澤伸行

Columns

Issue No. 6: Expectations for Drug Discovery and Health Research Using Simple Model Organisms – From the Perspective of ICT Utilization

2024.07.05
This series is based on the recognition that “drug development is entering a major t… 黒澤伸行