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[在2024年为小动物提供新药]

Christin Jana Kamutzki1, Ilka Ute Emmerich1

  • 1Institut für Pharmakologie, Pharmazie und Toxikologie, Veterinärmedizinische Fakultät, Universität Leipzig.

Tierarztliche Praxis. Ausgabe K, Kleintiere/Heimtiere
|April 15, 2025
PubMed
概括

2024年,在德国推出的用于小动物的新兽药包括治疗,焦虑和糖尿病的药物. 还批准了一种针对子出血性疾病病毒的新疫苗.

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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...