Pharmacovigilance and Pharmacoepidemiology Journal is an OpenAccess peer reviewed scientific publication encompasses the wide range of Premarketing Clinical Trial Safety articl">

Pharmacovigilance and Pharmacoepidemiology (ISSN: 2638-8235)

Premarketing Clinical Trial Safety

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Premarketing Clinical Trial Safety, Source: FDA Requirements for ensuring Premarketing Clinical Trial

The Premarketing Clinical Trial Safety module provides a framework and details around drug safety requirements for clinical trials for drugs in humans. This module provides information about safety and ethical safeguards in place to protect human subjects in clinical trials. The typical clinical process of pre-marketing development consists of two successive periods that complete each other. The first one or learning phase that investigates, and the second one or confirmatory phase that validates. The learning phase corresponds to the phases traditionally labelled I and II and the confirmatory phase covers the traditional late phase II and phase III. Premarketing studies will provide the details on individual case reporting and aggregate reporting requirements. Finally, the module will discuss risk assessment and the premarketing review of safety data in an application. Pharmacoepidemiology Researches invites an article to publish in the Journal of Pharmacovigilance and Pharmacoepidemiology. Pharmacovigilance and Pharmacoepidemiology is a scholarly journal maintaining high standards of Pharmacoepidemiology Researches.

Editorial Board List

Professor
Department of Pharmacy
Oman Medical College
Sultanate of Oman

Ozgur Karcioglu
Professor
Department of Emergency Medicine
Istanbul Education and Research Hospital
Istanbul,Turkey

Clinical researcher
department of forensic science and toxicology
Jordan University of Science and Technology
Jordan

Highly Accessed Articles List

Research Article : D-Cell Hypothesis (Trace Amine Hypothesis) of Schizophrenia, and importance of Trace Amine-Associated Receptor, Type 1 (TAAR1)

Keiko Ikemoto


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Research Article : Clinical Particularities of Drug-Induced Agranulocytosis or Severe Neutropenia in Elderly Patients

Emmanuel Andrès, Rachel Cottet Mourot, Olivier Keller, Khalid Serraj and Thomas Vogel


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Mini-Review : Variable Responses to Vitamin-D Dosing

Gokhale SG and Gokhale Sankalp


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Review Article : Preclinical Toxicity Studies-Tool of Drug Discovery

N.Venkatesan and M. Ramanathan


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Research Article : Novel Phytochemical Constituents Identified from the Seeds of Mesua Ferrea L and their Anticancer Activity
Faizan DK, Mehta BK, Yasir AL and Masood AK
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Research Article : The Effect of Curcumin in Patients with Chronic Fatigue Syndrome (or) Myalgic Encephalomyelitis Disparate Responses in Different Disease Severities
C(Linda) MC van Campen*and Frans C Visser
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Review Article : Role of Stem Cells in Health Science and Medicine
Rimsha Imam, Aqsa Saeed and Rana Khalid Iqbal
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Review Article : Glycemic Index of Selected Foods in Jamaica
Ryan D Francis, Perceval S Bahado-Singh, Andrew O Wheatley, Ann Marie Smith and Helen N Asemota
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Research Article : Awareness of Veterinary Drug Retail Outlets on Antimicrobial Resistance and its Containment Strategy in Ethiopia

Hailu Zeru*, Aynalem Gemechu, Tenaw Andualem, Hayat Seid and Fikadu Mengesha


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Research Article : Effect of Kaempferol, Diminazene Aceturate and their Combination on Hematological Parameters in Trypanosoma brucei brucei Experimentally Infected Mice
Muhammad Y, Suleiman MM, Jatau ID and Chiroma MA
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