scholarly journals Regulatory policies on medicines for psychiatric disorders: is Europe on target?

2007 ◽  
Vol 190 (2) ◽  
pp. 91-93 ◽  
Author(s):  
Corrado Barbui ◽  
Silvio Garattini
Keyword(s):  
Central Nervous System ◽  
Psychiatric Disorders ◽  
Marketing Authorisation ◽  
European Medicines Agency ◽  
Regulatory Body ◽  
Scientific Advice ◽  
Medicinal Products ◽  
Safety And Efficacy ◽  
Regulatory Policies ◽  
The Central Nervous System

SummaryThe European Medicines Agency (EMEA) is the regulatory body that provides the institutions of the European Community with the best possible scientific advice on the quality, safety and efficacy of medicinal products. Drugs approved by the EMEA are automatically marketable in all the European member states. Since the beginning of the EMEA's activities a number of drugs acting on the central nervous system obtained marketing authorisation. This editorial highlights some aspects of the EMEA rules that may negatively affect the evaluation of medicines for psychiatric disorders.

Pediatric Fronto-Orbital Skull Reconstruction

2021 ◽  
Author(s):  
Andrew M. Ferry ◽  
Rami P. Dibbs ◽  
Shayan M. Sarrami ◽  
Amjed Abu-Ghname ◽  
Han Zhuang Beh ◽  
...  
Keyword(s):  
Central Nervous System ◽  
Facial Trauma ◽  
Limited Data ◽  
Significant Morbidity ◽  
Craniofacial Skeleton ◽  
Optimal Care ◽  
Orbital Reconstruction ◽  
Safety And Efficacy ◽  
The Central Nervous System ◽  
Orbital Region

AbstractCraniofacial surgery in children is a highly challenging discipline that requires extensive knowledge of craniofacial anatomy and pathology. Insults to the fronto-orbital skeleton have the potential to inflict significant morbidity and even mortality in patients due to its proximity to the central nervous system. In addition, significant aesthetic and ophthalmologic disturbances frequently accompany these insults. Craniosynostosis, facial trauma, and craniofacial tumors are all pathologies that frequently affect the fronto-orbital region of the craniofacial skeleton in children. While the mechanisms of these pathologies vary greatly, the underlying principles of reconstruction remain the same. Despite the limited data in certain areas of fronto-orbital reconstruction in children, significant innovations have greatly improved its safety and efficacy. It is imperative that further investigations of fronto-orbital reconstruction are undertaken so that craniofacial surgeons may provide optimal care for these patients.

Neurochemical Systems in the Central Nervous System

2013 ◽  
pp. 12-26
Author(s):  
Ariel Y. Deutch ◽  
Robert H. Roth
Keyword(s):  
Central Nervous System ◽  
Nervous System ◽  
Psychiatric Disorders ◽  
Neurotrophic Factors ◽  
Drugs Of Abuse ◽  
Large Majority ◽  
System P ◽  
Target Neuron ◽  
The Central Nervous System ◽  
The Brain

Chapter 2 describes the neurochemical organization of the brain. It summarizes the diverse types of molecules that neurons in the brain use as neurotransmitters and neurotrophic factors, and how these molecules are synthesized and metabolized. The chapter also presents the array of receptor proteins through which these molecules regulate target neuron functioning and the reuptake proteins that generally terminate the neurotransmitter signal. Today a large majority of all drugs used to treat psychiatric disorders, as well as most drugs of abuse, still have as their initial targets proteins involved directly in neurotransmitter function.

Biological correlates of personality: considerations on the possible usefulness of central nervous system peripheral markers

1993 ◽  
Vol 8 (3) ◽  
pp. 115-124 ◽  
Author(s):  
P Castrogiovanni ◽  
F Pieraccini ◽  
I Maremmani ◽  
D Marazziti
Keyword(s):  
Central Nervous System ◽  
Nervous System ◽  
Psychiatric Disorders ◽  
Human Studies ◽  
Biological Research ◽  
The Central Nervous System ◽  
Methodological Problems ◽  
Biological Substrates ◽  
Peripheral Markers ◽  
Made In

SummaryAlthough a great deal of biological research has been carried out on several psychiatric disorders, it is disappointing to see how little progress has been made in the field of the biology of personality. The authors underline the methodological problems that arise in the investigation of biological substrates of human personality and review both currently available and putative peripheral markers of the central nervous system that might be used in further human studies.

scholarly journals Mitochondria and the central nervous system: searching for a pathophysiological basis of psychiatric disorders

2014 ◽  
Vol 36 (2) ◽  
pp. 156-167 ◽  
Author(s):  
Emilio L. Streck ◽  
Cinara L. Gonçalves ◽  
Camila B. Furlanetto ◽  
Giselli Scaini ◽  
Felipe Dal-Pizzol ◽  
...  
Keyword(s):  
Central Nervous System ◽  
Nervous System ◽  
Psychiatric Disorders ◽  
The Central Nervous System

Immune Mechanisms Affecting the Functioning of the Central Nervous System (CNS)

2018 ◽  
pp. 47-64
Author(s):  
Moises E. Bauer ◽  
Natália P. Rocha ◽  
Wilson Savino ◽  
Antonio L. Teixeira
Keyword(s):  
Central Nervous System ◽  
T Cells ◽  
Nervous System ◽  
Psychiatric Disorders ◽  
Hippocampal Neurogenesis ◽  
Behavioral Symptoms ◽  
Immune Mechanisms ◽  
The Central Nervous System ◽  
Health And Disease ◽  
Impaired Cognition

This chapter presents an overview of the immune mechanisms affecting the functioning of the central nervous system (CNS). The cross-talk between the immune system and the CNS is established by three independent pathways: the humoral, neural, and cellular (leukocyte) routes. Of note, increased circulating pro-inflammatory cytokines and concomitant activation of brain-resident microglia can lead to impaired cognition and depressive behavioral symptoms. The activated microglia phenotype has been associated with neuroinflammation reported in neurodegenerative and psychiatric disorders. This chapter also reviews novel physiological roles for adaptive immunity (especially T cells) during health and disease. T cells support hippocampal neurogenesis, cognition, mood, resilience to stress, and are protective against the development of psychiatric disorders.

scholarly journals Social Experience-Dependent Myelination: An Implication for Psychiatric Disorders

2015 ◽  
Vol 2015 ◽  
pp. 1-6 ◽  
Author(s):  
Michihiro Toritsuka ◽  
Manabu Makinodan ◽  
Toshifumi Kishimoto
Keyword(s):  
Central Nervous System ◽  
Nervous System ◽  
Psychiatric Disorders ◽  
Conduction Velocity ◽  
Neuronal Activity ◽  
Social Experience ◽  
Multiple Factors ◽  
The Central Nervous System ◽  
Extracellular Molecules ◽  
Activity Dependent

Myelination is one of the strategies to promote the conduction velocity of axons in order to adjust to evolving environment in vertebrates. It has been shown that myelin formation depends on genetic programing and experience, including multiple factors, intracellular and extracellular molecules, and neuronal activities. Recently, accumulating studies have shown that myelination in the central nervous system changes more dynamically in response to neuronal activities and experience than expected. Among experiences, social experience-dependent myelination draws attention as one of the critical pathobiologies of psychiatric disorders. In this review, we summarize the mechanisms of neuronal activity-dependent and social experience-dependent myelination and discuss the contribution of social experience-dependent myelination to the pathology of psychiatric disorders.

scholarly journals The orexins/hypocretins: hypothalamic peptides linked to sleep and appetite

2002 ◽  
Vol 32 (6) ◽  
pp. 955-958 ◽  
Author(s):  
SHAHRAD TAHERI ◽  
SEPEHR HAFIZI
Keyword(s):  
Central Nervous System ◽  
Nervous System ◽  
Sleep Disorder ◽  
Psychiatric Disorders ◽  
Lateral Hypothalamus ◽  
Scientific Knowledge ◽  
State Of The Art ◽  
Molecular Techniques ◽  
Medical Community ◽  
The Central Nervous System

The orexins/hypocretins are novel neuropeptides synthesized by neurons whose cell bodies are located in the lateral hypothalamus. Although these neurons are few in number, they send projections widely throughout the central nervous system (Kilduff & Peyron, 2000). There has been great excitement about the orexins/hypocretins from both the scientific and medical community. These peptides are remarkable in that they were discovered using state-of-the-art molecular techniques before their physiological actions were studied. Furthermore, there has been an exponential progress in our scientific knowledge of these peptides culminating in the orexins/hypocretins being linked to the sleep disorder, narcolepsy. With the importance of the orexins/hypocretins in sleep and arousal being increasingly recognized, it is likely that these peptides are altered by or contribute to several medical and psychiatric disorders.

scholarly journals Where is Industry Getting it Wrong? A Review of Quality Concerns Raised at Day 120 by the Committee for Medicinal Products for Human Use during European Centralised Marketing Authorisation Submissions for Chemical Entity Medicinal Products

2009 ◽  
Vol 12 (2) ◽  
pp. 181 ◽  
Author(s):  
John Joseph Borg ◽  
Jean-Louis Robert ◽  
George Wade ◽  
George Aislaitner ◽  
Michal Pirozynski ◽  
...  
Keyword(s):  
Marketing Authorisation ◽  
Drug Product ◽  
Point Of View ◽  
Chemical Entity ◽  
European Medicines Agency ◽  
Medicinal Products ◽  
Drug Products ◽  
Human Use ◽  
Consistent Information ◽  
The Impact

ABSTRACT – Purpose. The aim of this study was to identify common trends in the deficiencies identified in the quality part of the dossier during the evaluation of marketing authorisation applications for medicinal products for human use submitted through the EU’s centralised procedure. Methods. We analysed all the adopted Day 120 list of questions on the quality module of 52 marketing authorisation applications for chemical entity medicinal products submitted to the European Medicines Agency and evaluated by the Committee for Medicinal Products for Human Use (CHMP), during 12 consecutive plenary meetings held in 2007 and 2008. Subsequently we calculated the frequency of common deficiencies identified across these applications. Results. Frequencies and trends on quality deficiencies have been recorded and presented for 52 marketing authorisation applications. 32 “Major Objections” originated from 13 marketing authorisation applications. 13 concerned were raised regarding drug substances and 19 for drug products. Furthermore, 905 concerns on drug substance and 1,054 on drug product were also adopted. Conclusions. The impact of the frequencies and trends in quality deficiencies that were identified are discussed from a regulatory point of view. It is expected that the results of this study will not only be of interest to pharmaceutical companies but will also aid regulators’ in obtaining consistent information on drug products based on transparent rules safeguarding the necessary pharmaceutical quality of medicinal products.

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