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Guideline on good pharmacovigilance practices (GVP) Regulations

Guideline on good pharmacovigilance practices (GVP) - Definition Regulations

Guidelines for Biowaiver Regulations

Guidance for Submission Regulations

Data Requirements for the Renewal of Marketing Authorizations for human medicinal products Regulations

Policy Guidance for Pharmaceutical Reference Standard Regulations

Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Amlodar Capsules (10 mg amlodipine) Produced by Dar AlDawa / Jordan versus Amlor® Capsules (10 mg amlodipine) Produced by Pfizer / KSA, in healthy subjects under fasting condition. Drug Clinical Trial

Randomized, three-way, three-period, single oral dose, open-label, crossover, bioequivalence study to compare Torvacol tablets (20 mg atorvastatin) Produced by JPM / Jordan, versus Lipitor® tablets (20 mg atorvastatin) Produced by Pfizer / Irland in healthy subjects under fasting conditions. Drug Clinical Trial

Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Narapril tablets (20 mg enalapril) Produced by Julphar / UAE versus Renitec® tablets (20 mg enalapril) Produced by Merck Sharp & Dohme / UK, in healthy subjects under fasting condition. Drug Clinical Trial

Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Glymide tablets (5 mg glibenclamide) Produced by Julphar / UAE versus Daonil® tablets (5 mg glibenclamide) Produced Sanofi-Aventis / Germany, in healthy subjects under fed condition. Drug Clinical Trial