Anavex Life Sciences Corp (AVXL)

[Investor2014]

Nobody improves in a P1 study.

Some people in the p1 improved with lower concentration than others.

Because such a trial is testing drug safety in human healthy volunteers and is most often a Dose Escalation Study (SAD) design to record Adverse Events (AEs) and to find Dose Limiting Adverse Event (DLAEs), just like the A2-73 and A3-71 P1 trials.

Such as study often includes:

Pharmacokinetics vs. Pharmacodynamics
The difference between pharmacokinetics (PK) and pharmacodynamics (PD) is that pharmacokinetics is the movement of drugs through the body, whereas pharmacodynamics is the body’s biological response to drugs. In the simplest terms, pharmacokinetics is what the body does to the drug and pharmacodynamics is what the drug does to the body.

PK describes a drug’s absorption, distribution, metabolism, and excretion properties (known as ADME) and PD describes how biological processes in the body respond to or are impacted by a drug. While PK describes a drug’s exposure by characterizing its ADME properties and bioavailability as a function of time, PD describes a drug’s response in terms of biochemical or molecular interactions. PK/PD together can be thought of as an exposure/response relationship.

Understanding the exposure-response relationship (PK/PD) is key to the development and approval of every drug. PK and PD data contribute to about 25% of what is in a drug package insert or drug label. Strategic planning of the overall drug development program and an intelligent pharmacokinetic study design can accelerate the development process to help ensure safety and efficacy endpoints are achievable.

So something new to learned about biotech today.