Veterinary Pharmacovigilance in the European Union

Woodward, K. N.

doi:10.1002/9781444322958.ch2

Cited by 4 publications

(4 citation statements)

References 41 publications

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“…Ovo je iznenađujuće s obzirom da u ovoj zemlji postoji zakonska obaveza veterinarskih stručnjaka da prijave sve neželjene reakcije veterinarskih lekova (Naidoo i Sykes, 2006). Iako se čini da se neželjene reakcije na veterinarske lekove retko javljaju, one mogu biti česte i to kao posledica profesionalne greške ili nepravilne primene (Woodward, 2009).…”

Section: Rezultati Rada I Diskusijaunclassified

The importance of monitoring adverse drug reactions

Stojanović¹,

Kovačević²,

Zugic³

2015

Letopis nau rad Poljop fak

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REZIME UVODU razvijenim zemljama, shodno naporima kliničkih farmakologa i farmaceuta, farmakovigilanca se razvila u naučnu i veoma dinamičnu kliničku disciplinu. Začetak razvoja farmakovigilance vezuje se za tzv. talidomidsku katastrofu. Talidomid se u ranim 60-im godinama prošlog veka propisivao trudnicama za uspavljivanje i smanjenje mučnine, a njegova primena je izazvala 10.000-15.000 slučajeva teške deformacije ekstremiteta kod dece čije su majke uzimale ovaj lek (Sherman i Strauss, 1986). Posle ovog slučaja, mnoge zemlje su uspostavile sistem praćenja bezbednosti lekova, a sve u cilju ranog otkrivanja i prevencije mogućih rizika u vezi sa njihovom primenom. U Sjedinjenim Američkim Državama (SAD), talidomidska katastrofa je podstakla Agenciju za hranu i lekove (Food and Drug Administration -FDA) da od sponzora zahteva da testiraju i utvrde relativnu bezbednost leka, pre pokretanja kliničkih ispitivanja za utvrđivan-30 dr Dragica Stojanović, red. prof., mr Zorana Kovačević, asistent, Departman za veterinarsku medicinu, Poljoprivredni fakultet, Novi Sad 2 dr Gordana Žugić, Agencija za lekove i medicinska sredstva Srbije, BeogradRad je realizovan po projektu TR31062Letopis naučnih radova Godina 39 (2015), Broj 1, strana 135

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Section: Rezultati Rada I Diskusijaunclassified

The importance of monitoring adverse drug reactions

Stojanović¹,

Kovačević²,

Zugic³

2015

Letopis nau rad Poljop fak

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“…In some areas of the world, veterinary products may be partially regulated by agricultural, environmental, and/or health agencies. 52–59…”

Section: Development Of Veterinary Drugsmentioning

confidence: 99%

“…In some areas of the world, veterinary products may be partially regulated by agricultural, environmental, and/or health agencies. [52][53][54][55][56][57][58][59] In addition, for veterinary products, there are regulatory requirements to ensure that any residues persisting in tissues after slaughter of food animals, secreted into milk, or that may find their way into foods like honey, are not toxic to consumers and do not pose unacceptable risks to users. 56 Studies to predict safety and efficacy of veterinary products are similar to those for human products and include evaluation of toxicity, pharmacology, microbiology, consumer safety, user safety, and target animal safety (TAS).…”

Section: Development Of Veterinary Drugsmentioning

confidence: 99%

The Role of the Toxicologic Pathologist in the Biopharmaceutical Industry

et al. 2011

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Toxicologic pathologists contribute significantly to the development of new biopharmaceuticals, yet there is often a lack of awareness of this specialized role. As the members of multidisciplinary teams, toxicologic pathologists participate in all aspects of the drug development process. This review is part of an initiative by the Society of Toxicologic Pathology to educate scientists about toxicologic pathology and to attract junior scientists, veterinary students, and veterinarians into the field. We describe the role of toxicologic pathologists in identifying candidate agents, elucidating bioactive pathways, and evaluating efficacy and toxicity in preclinical animal models. Educational and specialized training requirements and the challenges of working in a global environment are discussed. The biopharmaceutical industry provides diverse, challenging, and rewarding career opportunities in toxicologic pathology. We hope that this review promotes understanding of the important role the toxicologic pathologist plays in drug development and encourages exploration of an important career option.

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“…It has a rapid onset and relatively short duration of action (Blane et al 1967;DeRossett & Holtzman 1984). Etorphine's use in immobilising drug combinations is popular because of its ability to induce reversible catatonic immobilisation and analgesia at relatively low doses compared to other anaesthetics, and because its high potency allows for the administration of small volumes via projectile darts (Blane et al 1967;Riviere & Papich 2009;Woodward 2009).…”

Section: Introductionmentioning

confidence: 99%