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What is a clinical pharmacology study? A clinical pharmacology study is a systematic scientific study performed with an active pharmaceutical ingredient (API) on volunteer, healthy or unhealthy human subjects. A clinical pharmacology study is conducted in order to discover or verify the API therapeutic effects and/or identify its adverse reactions and/or study its absorption, distribution, metabolism (biotransformation) and excretion with the purpose of determining its efficacy and safety. Clinical pharmacology studies are classified into four phases characterized as follows: Phase I: this phase relates to the initial introduction of a new API in human beings, in order to determine its metabolism, pharmacologic actions and side effects on increasing doses and, if possible, to obtain early evidence of its efficacy. This phase includes the study of the variations among sub-populations and the interactions with food and other drugs. These studies become the basis for using the product in successive phases. Usually, Phase I studies are strictly monitored and may be carried out on volunteer healthy subjects or, occasionally, patients. Phase II: the efficacy and safety of the different dose ranges are determined in this phase. Likewise, the dose-response relations will be determined, if possible, so as to obtain a sound background for the design of widened therapeutic studies (Phase III). Phase III: this phase studies are performed on large and varied groups of participants in order to determine both the short and long-term benefit-risk ratio of the proposed formulation(s) and the overall relative therapeutic value. The nature and characteristics of the most frequent adverse reactions and the API special characteristics are assessed in Phase III studies. These studies include clinically significant interactions and main effect modifying factors such as age, among others. Phase IV: these are studies conducted after the API marketing is approved in order to determine the therapeutic value, the appearance of new adverse reactions and/or the confirmation of frequency of the known ones and the treatment strategies. Randomization this is a method or mechanism used to assign the participants to the different treatment groups, in such a manner that the research participants bear the same probability of receiving any of the interventions envisaged in the clinical study. Placebo this is an inactive pharmaceutical ingredient used as a comparator in a clinical research, when appropriate and when subject protection criteria allow for its use.
 
Who can be a clinical pharmacology study sponsor? l pharmacology study sponsor? A sponsor is a physical person or legal entity who is responsible for the initiation, management and financing of a clinical pharmacology study.
 
Can any person participate in a clinical pharmacology study? Yes, every healthy or unhealthy person meeting the eligibility criteria to participate in a proposed clinical pharmacology study can join it. Eligibility criteria are the following:

1- Inclusion criteria: the set of conditions a person must meet to be able to participate in a given pharmacology study.

2- Exclusion criteria: the set of conditions determining that a person must not be included in a clinical pharmacology study.

3- Withdrawal or discontinuation criteria: the set of conditions determining that a participant should be withdrawn from the study for safety reasons.

 
Will the persons participating in a clinical pharmacology study be benefited from or damaged by it? Every participant of a clinical pharmacology study must know that the study is conducted because the intervention under study is reasonably assumed as beneficial for health. This does not mean that the subject will be benefitted from participating; moreover, he or she could be damaged.
 
In what type of institutions are clinical pharmacology studies conducted? Clinical pharmacology studies are conducted in either public or private owned institutions which have been previously proposed by the sponsor and authorized by ANMAT.
 
What requirements should a person consider when deciding to participate in a clinical pharmacology study? To clearly understand all the reasons and grounds for having been invited to join a clinical pharmacology study, as well as the guidelines he or she should follow throughout the study. All this must be included in the written information the prospective participant should be given by the study doctor (an investigator doctor who is a member of the research team) prior to signing the participation consent (informed consent). The potential participant must not sign the informed consent if he or she has not clearly understood the information provided. Likewise, the prospective participant is encouraged to discuss the study details with the doctor or take advice from the ethics committee involved.
 
What is the Informed Consent? It is the process by which a person confirms his or her decision to participate in a human health research study To clearly understand all the reasons and grounds for having been invited to join a clinical pharmacology study, as well as the guidelines he or she should follow throughout the study. All this must be included in the written information the prospective participant should be given by the study doctor (an investigator doctor who is a member of the research team) prior to signing the participation consent (informed consent). The potential participant must not sign the informed consent if he or she has not clearly understood the information provided. Likewise, the prospective participant is encouraged to discuss the study details with the doctor or take advice from the ethics committee involved. after having been duly informed about all its relevant aspects. The informed consent is documented by means of signing a specific form.
 
 
 
 
 
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