Chapter 2.3. Type of study and general design

From the point of view of the knowledge that the doctor and the patient they have about the medication that is receiving the patient distinguish the open studies and the blind studies. In the open studies as much the investigator as the patient knows the treatment that receives the patient. Usually they are opened to [...]

Chapter 2.2. Type of study and general design

The design of an investigation study is the general plan of the investigator to obtain the answer to a raised question, that is to verify the investigation hypothesis. The selection of the type of design depends on the objective of the study, the resources on which count the investigator, the scope where to the results [...]

Chapter 2.1.Clinical research protocol..Methodology

Methodology:
In this section, I will describe in detailed :
l) The variables that will be evaluated in each clinical study and the form to measure them.
2) The design of the study .
3) Techniques and procedures that are going away to use to reach the proposed objectives.
4) The procedures to safeguard the security of the patients during [...]

Chapter 2.0.Clinical Research Protocol .

With this post begins the chapter 2. It´s about the clinical research protocol.

The protocol is a methodologist and administrative document where all the necessary information for the execution of an investigation is. In fact the protocol is the “handbook of operations” of all investigation.

TITLE OF THE INVESTIGATION

It must be short, precise and [...]

Chapter 1.3. Introduction to clinical trials. Phase IV , Beta error, Planning a Trial

There is another type of error that can be generated in these studies and that are not to realize that one . We called error beta to the highest probability of not recognizing a difference between treatments that in fact exists. This point is very serious since it implies that it would be let pass [...]

Chapter 1.2 .Introduction to clinical trials. Phase II & III studies.

Phase II

If the work made with the new molecule well were planned and executed and phase I were completed finding the answer to the three fundamental questions of this phase (safe dose recommended, profile of toxicity and pharmacokinetics in human beings), it will know that dose of the new drug is going away to use [...]

Chapter 1.1.Introduction to clinical trials.

The animal studies, and especially toxicological, have been criticized by defending organizations of the animals. They are essential to the future establish the necessary parameters of security for use in humans. In this stage of the development of a new molecule they are made, generally, the following studies:
1) Pharmacodynamics studies: To evaluate the actions [...]

Chapter 1.0. Introduction to clinical trials.

The investigation and development of a new drug, biological product or medical device are a long and complex process that follows a logical, systematic and planned sequence in careful form and that requires the application of the scientific method, the participation of disciplinary groups and adapted economic resources. In this chapter a general vision of [...]