Syed Abid Hassan
Dallah Pharma, Saudi Arabia
Scientific Tracks Abstracts: J Clin Exp Pharmacol
Chemical/Molecular: Anything which has mass; consisting of matter is chemical, is a substance that is produced or used in a process (reaction) involving changes to atoms or molecules “Chemical” as an adjective; means “of or pertaining to chemistry“ i.e. indicates a relationship to chemistry or to the interaction between substances. Entity: A thing with distinct and independent existence. An NCE or NME is a drug that has an active moiety which has not been previously approved by the FDA. A New Chemical Entity (NCE) is a drug (developed by INNOVATOR company) that contains NO active moiety (therapeutically beneficial part of molecule or ion in a drug which is typically given a name as it can be found within other kinds of molecules as well. For instance, the acetyl moiety is a component of many organic:
• acetic acid,
• acetylcholine,
• acetyl-CoA,
• acetylcysteine,
• acetaminophen (paracetamol),
• acetylsalicylic acid (aspirin)
that has been approved by the FDA in any other
application.
The following are the Steps involved from the Laboratory to Your Medicine Cabinet
Step 1: Drug discovery and target validation
Step 2: Pre/Non-clinical testing on Animals
Step 3: IND (Investigational New Drug) application filing
Step 4: Phase I Clinical studies with Healthy volunteers
Step 5: Phase II Clinical studies with Patients
Step 6: Phase III Clinical studies with Patients
Step 7: NDA (New Drug Application) filing
Step 8: Manufacturing and Marketing
Step 9: Phase IV Post Marketing Studies for adverse reaction, side effects etc
Dr. Syed Abid Hassan is founder of Bismil Welfare Society for social welfare works. He has done his Ph.D. in Chemistry, Diploma in Pharmacy, M.B.A. (in International Business). He is a Certified Lead Auditor for QMS (Quality Management System), by BSI (British Standard Institute) UK, and Certified Lead Auditor for ISO13485 (specialized in/for Medical Device) by IRCA (International Register of Certificated Auditor) UK.