After the "Thalidomide Incident" in the 1960s, regulatory authorities in many countries established voluntary reporting systems for adverse drug reactions to collect adverse drug reactions.
Protein drugs, also known as biologics, have revolutionized the treatment of various diseases by specifically targeting specific molecules or pathways involved in disease progression.
As indicated, effective use of protein drugs can be compromised by their instability in the body, rapid rates of clearance, premature uptake by tissues and immunogenicity or antigenicity.
Pharmacometric models describe the current understanding of the drug/therapy and simulations help predict next steps for testing the drug in animals and humans.
The market is expected to benefit from constant growth in the genomics and genetic modification markets as progress in genetic instruments simplifies oligonucleotide synthesis.
Compounds resembling key metabolites can compete with them or disrupt their use, or get incorporated into biological macromolecules, creating faulty structures that hinder cell growth and can be lethal.
The definition of IBD in the Guideline refers to the date of the first marketing approval for any product containing the active substance granted to any company in any country in the world.