Defining dosage

Defining dosage

The landmark studies on therapeutic hypothermia have demonstrated an improved outcome in comatose patients after cardiac arrest targeting a temperature of 33°C for 24 hours [1,2]. The investigated temperature of 33°C was derived from the results of animal studies suggesting the best compromise between neuroprotection and adverse events. In the decade that followed, no randomized controlled tria...

Defining disability – Re-defining policy

Introduction: In 2002, an EC study reported that different European countries define disability differently, and this is one of the primary reasons why no common Europe-wide policies on disability exist. The EU-MHADIE project was funded with the aim of producing recommendations and guidelines for future common disability policies. The WHO’s ICF classification and its bio-psycho-social model of ...

Proposal for defining the relevance of drug accumulation derived from single dose study data for modified release dosage forms

Recently, the European Medicines Agency (EMA) published the new draft guideline on the pharmacokinetic and clinical evaluation of modified release (MR) formulations. The draft guideline contains the new requirement of performing multiple dose (MD) bioequivalence studies, in the case when the MR formulation is expected to show 'relevant' drug accumulation at steady state (SS). This new requireme...

Normal Dosage

Liquisolid Dosage System: A Novel Approach for Dosage formulation

Liquisolid system is a novel concept of dosage formulation for water insoluble drugs and lipophilic drugs via oral route. Formulation concept of liquisolid technology involves water insoluble drugs dissolved in suitable non-volatile liquid vehicles, and converted in to compact by blending with selective powder excipients. Liquisolid compacts are compressible powdered forms of liquid medications...