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EMA: Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues

15.01.2015
The Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (EMEA/CHMP/BMWP/42832/05 Rev.1) lays down the ...

FDA: Draft Guidance - Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product

12.06.2014
This draft guidance is intended to assist spon sors with the design and use of clinical pharmacology studies to support a decision that a proposed therapeutic biological product is biosimilar to ...

EMA: Draft concept paper on revision of the points to consider on pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products (CHMP/EWP/2655/99) and conversion to a CHMP guideline

05.03.2014
This concept paper proposes a revision of the CHMP’s points to consider on pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products (CPMP/EWP/2655/99) and its ...

EMA: Draft guideline on the evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function

05.03.2014
Pharmacokinetic studies can be used to estimate drug exposure in subpopulations of patients with characteristics that might affect the pharmacokinetics of the drug, and alternative dosing regimens ...

EMA: Guideline on the clinical investigation of medicinal products for the treatment of urinary incontinence

25.07.2013
This guideline considers pharmacodynamic and clinical data required to support indications, dose regimens and durations of therapy for the treatment of urinary incontinence (UI). It applies to the ...

EMA: Guideline on non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight heparins (draft)

07.02.2013
This guideline lays down the non-clinical and clinical requirements for low-molecular-weight-heparin (LMWH)-containing medicinal products claiming to be similar to another one already marketed. ...

EMA: Guideline on the investigation of drug interactions

12.07.2012
The potential for pharmacokinetic interactions between new medicinal products and already marketed drugs should be evaluated. This applies to both effects of the medicinal product on other drugs ...