Obstacles in Drug Development and How to Overcome Them
Drug discovery and development is a complex, expensive undertaking that can often end in failure to secure drug approval for critically needed medicines. The pre-clinical and clinical phase of drug development starts after target identification. During this phase, missteps in overall strategy, IND-enabling animal studies, lack of bioavailability or drug stability, formulation and manufacturing challenges, […]
Why Your Early-Stage Drug Development Needs an R&D-Focused CDMO Partner
Early-stage drug development is best performed at an R&D-focused CDMO. Initial formulation and small batch manufacturing for proof-of-concept clinical trials require speed, agility, and cost-effectiveness as opposed to the scale of a Phase III or routine commercial manufacturing-focused CMO. Preclinical work in early-stage drug development encompasses the following: These activities must generally be completed prior […]