The<unk>  is the full<unk>  of bringing a new drug (i.e., new chemical entity) to market from drug discovery through clinical trials to approval. Typically, companies spend tens to hundreds of millions of U.S. dollars on drug<unk> . One element of the complexity is that the much-publicized final numbers often not only include the out-of-pocket expenses for conducting a series of Phase I-III clinical trials, but also the capital<unk> s of the long period (10 or more years) during which the company must cover out-of-pocket<unk> s for preclinical drug discovery. Additionally, companies often do not report whether a given figure includes the capitalized<unk>  or comprises only out-of-pocket expenses, or both. One study assessed both capitalized and out-of-pocket<unk> s as about US$1.8 billion and $870 million, respectively. In an analysis of the drug<unk> <unk> s for 98 companies over a decade, the average<unk>  per drug developed and approved by a single-drug company was $350 million. But for companies that approved between eight and 13 drugs over 10 years, the<unk>  per drug went as high as $5.5 billion, due mainly to geographic expansion for marketing and ongoing<unk> s for Phase IV trials and continuous monitoring for safety. A new study in 2020 estimated that the median<unk>  of getting a new drug into the market was $985 million, and the average<unk>  was $1.3 billion, which was much lower compared to previous studies, which have placed the average<unk>  as $2.8 billion. Alternatives to conventional drug<unk>  have the objective for universities, governments and pharmaceutical industry to collaborate and optimize resources.
Cost of drug development
Good clinical practice
Bicycle safety
Medication costs
Personal health application
Automotive safety
Usual, customary and reasonable
Drug Safety