Tag: FDA guidelines

Prescriber Attitudes on NTI Drug Substitution: Risks, Regulations, and Current Practices

Prescribers have mixed views on substituting generic versions of Narrow Therapeutic Index drugs. FDA guidelines and state laws influence decisions, with some states requiring patient consent. Real-world data shows higher brand usage for critical NTI drugs like warfarin and tacrolimus. Communication between doctors and pharmacists is key to managing substitution risks. Ongoing research aims to improve safety and trust in generic NTI options.

Quality by Design in Generic Drug Development: Modern Science-Based Approaches

Quality by Design (QbD) is now mandatory for generic drug development, shifting focus from end-product testing to science-based design. Learn how QbD improves bioequivalence, cuts approval times, and saves millions-while avoiding common pitfalls.