أدوات مجانية للمتخصصين في الصناعة الدوائية · تعمل في متصفحك ولا يغادر ما تدخله جهازك
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حاسبة متوسط درجة الحرارة الحركي وتقييم الانحرافات
Computes mean kinetic temperature from a temperature record and assesses shipment or storage excursions against the product's climatic zone, using the office's stability dataset for the Arab markets.
حاسبة عتبات الشوائب وفق ICH Q3A وQ3B
Derives reporting, identification and qualification thresholds for drug-substance and drug-product impurities from the maximum daily dose, following ICH Q3A and Q3B.
مدقق الإعفاء الحيوي وفق تصنيف BCS ودليل ICH M9
Walks a product through the ICH M9 biowaiver logic — BCS class, dissolution criteria and excipient considerations — to show whether an in-vivo bioequivalence study may be waived.
محاكي انقطاع سلاسل التوريد
Simulates supply-chain disruption scenarios for a product's API and excipient portfolio, using sourcing origins, routes and lead-time bands from the office's 363-substance data bank.
مصنف الأجهزة الطبية وفق الأنظمة الأوروبية والأمريكية والسعودية
Classifies a medical device under EU MDR rules, the US FDA scheme and SFDA, and shows the registration picture across a 22-market atlas.
محدد الحد الفاصل بين الببتيد والمنتج البيولوجي
Settles which side of the regulatory border a molecule sits on — at 40 amino acids or fewer it is a drug and a copy is a generic; above, a protein whose copy is a biosimilar — with the current FDA peptide guidance context.
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Cite as: AUPAM Experts' Office, Free regulatory & GMP calculators — AUPAM tools, retrieved 2026-08-31, https://aupameo.org/tools/