Dissolution Testing: What it is, How we do it, and Why it matters
Dissolution testing is a fundamental analytical technique in the [...]
Endotoxin Testing: A Complete Approach at Kymos Group
At Kymos Group, we continuously expand our analytical capabilities [...]
Denosumab Biosimilars: Accelerating Drug Development for RANKL Inhibitors
Denosumab represents one of the leading biologics applied today [...]
New FDA Guideline for Oligonucleotide Therapeutics
In June 2024, the FDA published the final version [...]
New EMA Guideline on Topical Products: Impact on IVRT and IVPT
The European Medicines Agency (EMA) announced in October 2024 the [...]
miRNA Analysis: From Fundamental Research to Product Innovation
The Nobel Prize in Medicine for 2024 brings long-awaited recognition [...]
ICH M10 Comparison with EMA and FDA Past Guidelines on Bioanalytical Method Validation
Although the ICH has published recommendations for the validation of [...]
Extractables & Leachables: Analysis, Study Design and ICH Q3E Guideline
When developing and releasing pharmaceutical products to the market, ensuring [...]
Transdermal Testing: Analysis and Quality Control of Transdermal Patches
Transdermal patches, or Transdermal Drug Delivery Systems (TDDS), are designed [...]
Stability Testing: What’s to come in 2024
Stability testing is an essential part of drug development as [...]