**2.5 Preformulation study challenges and mitigation**

There are various hurdles associated with successful drug product development. That's why a question that comes around scientists working in pharmaceutical product development is Why do 90% of drug development fail at the clinical stage, and what can be done to change that? [11]. The baseline difficulties related to drug candidate evaluation at the research and development level like market potency of a drug candidate, poor project plan, pre-submission challenges, drug development timelines, and cost of drug product development and thereafter the regulatory filing need to be investigated carefully [28]. Drug development starting from discovery is a long and costly process with high chances of failure. Generally, molecules failed to make a place in the market because they do not perform well in clinical phases II and III (40–50%), show unmanageable toxicity (30%), poor drug-like properties and strategic planning (10–15%), and fewer business opportunities (10%). Some of the drug discovery and developmental challenges are listed in **Table 1** [35].
