First time in human

Boxenbaum, H., DiLea, C., First-time-in-human dose selection allometric... 

CS, preclinical candidate selection I I II I, first time in human PI, phase 1 P2, phase 2 POC, proof of concept. 

Another interesting bit of history regarding tin came around 500 BCE, when the tin mines of the eastern Mediterranean region were depleted. This created a problem because tin, a rather rare metal, was very necessary to make the hardened bronze alloy for weapons and tools. This also is thought to be the first time in human history that a mineral was depleted in a region due to mining. 

When an antigen is administered for the first time in human body, the antibodies that is elicited first is entirely of the IgM type. The IgM antibody titres rise steadily during the next three to four days, reaches a peak and then declines. Meanwhile if the antigenic stimulus was sufficient, IgG antibody appears in a few days, reaches a peak in a week time and gradually falls over a period of weeks or months, this is called as primary response. 

Fig. 1. The Pharmaceutical Pipeline. The different phases of drug development are outlined, starting with a lead compound and moving forward through preclinical and clinical testing towards market approval. (CS candidate selection IND investigational new drug application POC proof of concept NDA new drug application FTIH first time in human).

If we point to the specifications of the brain basis of intellect vs. instinct, the answer is a resounding yes. We see, most clearly in the case of waking vs. dreaming consciousness, how the brain s overall chemical states and how its associated regional emphasis shift in ways that give us, for the first time in human history, a blueprint for the scientific psychology that Freud envisaged. 

Nasal spray 18 healthy volunteers in Bristol-Myers first time in humans study withdrawal not seen when drug discontinued after 16 days92 Nasal spray Bristol-Myers clinical trial in post-Caesarian-section pain no assessment of abuse liability or withdrawal93 Continued... 

The answers to these questions drive the next issue—of when to switch vendors. The needs of the project may drive the sponsor to run one or more parallel programs with other vendors one campaign to produce materials for first time in human studies, another to produce phase II clinical trail supplies materials, and a third to determine the impact of the different campaigns on the clinical program. Now what started as one sponsor-vendor relationship for one project has turned into three. Multiply this by the number of projects your company is managing at any given time and you will begin to understand the extent of the impact of such a decision. 

While the efficacy of an approved drug is extremely relevant, so too is its safety profile, sometimes referred to as its toxicity profile since every drug will have some unwanted side effects. Initial safety evaluations are conducted in healthy adult subjects in first time in human (FTTH) studies. The terms healthy volunteers or normal volunteers are often seen in this context, but they seem particularly unsuitable By definition, all participants in all clinical trials are volunteers, and the use of the word volunteer in just Fl IH trials could mistakenly be seen to imply that participants in other trials are not volunteers. Additionally, the word normal seems questionable in that it may mistakenly be seen to imply that subjects in other trials are abnormal in ways not related to having or not having the disease or condition of interest. The term healthy adult subjects circumvents such misperceptions. 

For the first time in human history, the future of mankind is in our own hands. Onto the road leading to a sustainable and peaceful future, we ourselves have placed several "roadside bombs." We must safely pass these. We must avoid energy wars, the collapse of the global economy, creating a drastic change in the climate or bringing a nuclear winter. 

The term should be considered allows flexibility either to do the studies before first time in humans or at a later stage of development. In practice, these studies are most often available before IND, because one wants to cope with this issue in time and wants to provide best safety to volunteers and patients. 

As Pauling took up the technique, only 10 years after its discovery, laboratories in Europe were already describing the atomic architecture of dozens of crystals, from rock salt to diamonds. They were confirming some old theories— finding, as predicted, that carbon atoms often join to make three-sided pyramids called tetrahedra—but throwing out others. Hard data about structure at the atomic level could now, for the first time in human history, be used to test chemists ideas. 

The organophosphate (OP) insecticide-induced intermediate syndrome (IMS) was reported for the first time in human patients in Sri Lanka in 1987 (Senanayake and Karalliede, 1987 Karalliede and Henry, 1993). Thereafter, this syndrome has been reported in South Africa (1989), Turkey (1990), Belgium (1992), India (2003), and many other countries. IMS is clearly a separate entity from acute... 

Finally, how informed could a subject be about a new chemical entity when the aim of the study is to gain information for the first time in humans To balance the apparent lack of information, the investigator is responsible for carefully monitoring the subject during all stages of the investigation. 

With these encouraging reports from the old French literature, Turnicliffe and Stebbing in England tried pure oxygen intravenously for the first time in humans in 1916. 

Attain activity with druglike properties to achieve candidate selection (first time in humans). 

Clinical development continues with the application of the learn-confirm-learn paradigm applied to drug development. Scale up to the first-time-in-human (FTIH) study is best done by the application of sound PM methods as described by several authors (10, 51, 56). 

---