i) Regulatory requirements

CLINICAL TRIALS = MOST PLACES LEGAL REQUIREMENT BEFORE NEW DRUG CAN BE SOLD/CLAIMED TO HAVE THERAPEUTIC BENEFIT/CLAIMED TO BE SAFE

International regulatory requirements published by International Committee on Harmonization
ICH harmonize regulation clinical trials in USA, EU & Japan - prevents unnecessary duplication of clinical research programmes in these regions
Regulatory requirements for clincal trials:
1. All trial participants must given their free & informed consent prior to participation - privacy must be assured
2. Trial must follow a trial protocol - which has been previously approved by constituted ethics committee
3. Only properly qualified physicians can provide medical care to trial subjects - i.e. cardiologists for cardiac drugs
4. Clinical trial data must be recorded, handled & stored allowing accurate reporting, interpretation & verification
Researchers must submit an Investigational New Drug Application - contains info regarding:
- Animal pharmacology & toxicology studies
- Manufacturing info
- Clinical protocols + investigator info (patient info, trial design & process, outcome measures)

	Creado por Niamh McLoughlin hace más de 8 años

(Clinical development ) Pharmacology Apunte sobre Clinical development , creado por Niamh McLoughlin el 04/11/2017.