Author: ChemRealm
Industry
Pharmaceutical
Regulation
How ICH Guideline Topics Are Named And Categorized?
If you are new to the regulatory guidance, even some peers in the regulated field for a while, it is still quite unclear what are the M10, S6, R2 means in ICH guidelines. So this article...
Chemical
Pharmaceutical
Regulation
What are Nitrosamine Impurities in Drugs
Nitrosamine, formally known as N-nitrosoamine, is a class of organic molecules with the above core structure. These type of chemicals are believed carcinogenic due to their potential as alylating reagents inside cells, which will cause cancer....
GLP
Industry
Brief Introduction to Ten GLP Principles and How are they Audited
GLP is a quality system concerned with the organizational process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. While Good Laboratory Practices ( GLP ) in clinical studies...
Pharmaceutical
Regulation
A Quick Guide for IND Application
How many types of FDA IND application? There are multiple types of IND application. Generally, your IND will be either 1) commercial or 2) research. It depends on whether it will be used to support marketing application afterwards. There are then three...
Pharmaceutical
Regulation
A Quick Guide to FDA pre IND Meeting
What is a pre IND meeting with FDA? Pre IND meeting with FDA is an important step of IND application. An IND application is (a) sponsor(s) that submit the product’s data and information to FDA (Food...
cGMP
GLP
Industry
Regulation
GLP VS GMP testing
For beginners to regulated pharmaceutical industry, GLP(Good Laboratory Practice) and cGMP(Current Good Manufacturing Practice) probably are the two most encountered regulatory standards. In some case, it may feel like very similar in terms of analytical testing....
Industry
Regulation
FDA-Approved Radiopharmaceuticals
I am very interested in radiopharmaceuticals, so I posted several posts about it. And Recently, I am thinking about summarize the radiopharmaceutical that already approved safe and effective in treat disease. I found http://www.radiopharmaceuticals.info is a...
Sci&Tech
Basics of Radiopharmaceuticals
What is radiopharmaceutical? Radiopharmaceuticals include a group of radioactive agents used for either diagnostic or therapeutic interventions. Radiopharmaceutical therapy is defined by the delivery of radioactive atoms to disease-associated targets. But do not be confused with...
Sci&Tech
KRAS is no longer undruggable
A while ago, I wrote simply about the KRAS gene related research trend. It is official!! FDA grants FIRST accelerated approval to sotorasib for KRAS G12C mutated NSCLC. See the follow link for report by Fierce...
Industry
Sci&Tech
Program Overview: Small Business Innovation Research (SBIR) & Small Business Technology Transfer program (STTR)
When you come up a innovative idea that potentially can change the current tech market and enhance people’s life, why not chase your dream and bring your idea to market. Of course, you need funding to...