Pakiet 4

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1. Package 4 – FARICIMAB 2. A detailed description of the subject of the contract is contained in Annex No. 2 to the TOR – Pricing form. 3. The trade names provided in the TOR pricing form are exemplary. The contracting authority allows the possibility of submitting equivalent offers, i.e., pharmaceutical and therapeutic equivalents. Basic concepts and definitions regarding drug bioequivalence issues; modified according to Kaliszan and compared drugs contain the same amount of the active substance in the same (or essentially similar - e.g., tablets, capsules) drug form, corresponding to the same comparable standards and intended to be administered by the same route; pharmaceutical equivalence does not guarantee therapeutic equivalence as differences in excipients and manufacturing processes may cause differences in dissolution and bioavailability, and consequently in the effect of the pharmaceutical agent. Therapeutic equivalence Two agents are therapeutically equivalent if they are pharmaceutically equivalent and if, after administration in the same dose, their effects in terms of efficacy and safety are as expected based on relevant studies. 4. The rules for the implementation…

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