In the United States, new pharmaceutical products must be approved by the Food and Drug Administration (FDA) as being both safe and effective. This process generally involves submission of an Investigational New Drug filing with sufficient pre-clinical data to support proceeding with human trials. Following IND approval, three phases of progressively larger human clinical trials may be conducted. Phase I generally studies toxicity using healthy volunteers. Phase II can include pharmacokinetics and dosing in patients, and Phase III is a very large study of efficacy in the intended patient population. Following the successful completion of phase III testing, a New Drug Application is submitted to the FDA. The FDA review the data and if the product is seen as having a positive benefit-risk assessment, approval to market the product in the US is granted.
What type of filing is used before beginning human trials?
Investigational New Drug


Input: Catalan language
The ascription of Catalan to the Occitano-Romance branch of Gallo-Romance languages is not shared by all linguists and philologists, particularly among Spanish ones, such as Ramón Menéndez Pidal.

What kind of linguists do not like placing Catalan in the Occitano-Romance category?
Output: Spanish ones


Input: Article: Estonian language planners such as Ado Grenzstein (a journalist active in Estonia in the 1870s–90s) tried to use formation ex nihilo, Urschöpfung; i.e. they created new words out of nothing.

Now answer this question: What is another term for making up words from nothing?

Output: formation ex nihilo


Article: Additionally, there are issues of connections between different electrical services, particularly connecting intercity lines with sections electrified for commuter traffic, but also between commuter lines built to different standards. This can cause electrification of certain connections to be very expensive simply because of the implications on the sections it is connecting. Many lines have come to be overlaid with multiple electrification standards for different trains to avoid having to replace the existing rolling stock on those lines. Obviously, this requires that the economics of a particular connection must be more compelling and this has prevented complete electrification of many lines. In a few cases, there are diesel trains running along completely electrified routes and this can be due to incompatibility of electrification standards along the route.

Question: Why are disel trains  still used on electrified routes?
Ans: due to incompatibility of electrification standards


Here is a question about this article: While successful predation results in a gain of energy, hunting invariably involves energetic costs as well. When hunger is not an issue, in general most predators will not seek to attack prey since the costs outweigh the benefits. For instance, a large predatory fish like a shark that is well fed in an aquarium will typically ignore the smaller fish swimming around it (while the prey fish take advantage of the fact that the apex predator is apparently uninterested). Surplus killing represents a deviation from this type of behaviour. The treatment of consumption in terms of cost-benefit analysis is known as optimal foraging theory, and has been quite successful in the study of animal behavior. In general, costs and benefits are considered in energy gain per unit time, though other factors are also important, such as essential nutrients that have no caloric value but are necessary for survival and health.
What is the answer to this question: In optimal foraging theory, how are costs and benefits measured?
****
So... energy gain per unit time


Article: After the construction was complete there was no further room for expansion at Les Corts. Back-to-back La Liga titles in 1948 and 1949 and the signing of László Kubala in June 1950, who would later go on to score 196 goals in 256 matches, drew larger crowds to the games. The club began to make plans for a new stadium. The building of Camp Nou commenced on 28 March 1954, before a crowd of 60,000 Barça fans. The first stone of the future stadium was laid in place under the auspices of Governor Felipe Acedo Colunga and with the blessing of Archbishop of Barcelona Gregorio Modrego. Construction took three years and ended on 24 September 1957 with a final cost of 288 million pesetas, 336% over budget.

Question: Who blessed the first stone of the new stadium?
Ans:
Archbishop of Barcelona Gregorio Modrego