Information generated by clinical pharmacology studies can contribute up to 50% of the final product label. A coherent strategy towards this aspect of drug development is essential. consult2deliver have experience of small molecules and biologics, across several therapeutic areas including inflammation, cardiovascular and oncology. Through our expert knowledge of both clinical pharmacology and the regulatory environment we are able to offer clients an objective input into their development programmes, thereby helping them on their way to achieving global regulatory success.
consult2deliver have applied their expertise to address the following challenges
- The integration of pre-clinical PK/PD and toxicokinetic data to design and maximise the value of data from first in human (FIH) studies (Phase I) to determine starting dose in these studies
- Assessing the impact of clinical trial results on the further development of the compound
- Scientific reviews of the literature/data
- Drug:drug interaction potential of your compound; from clinical trial design to the collation of a co-medication policy in early patient studies
- Evaluation of novel formulations through the design, analysis and interpretation of bioavailability and bioequivalence studies
- Input into key regulatory documents
- Presentation of key data at Scientific Advice meetings with the MHRA , EMA and FDA.