Early drug development requires adherence to Good Manufacturing Practices (GMP) guidelines when manufacturing investigational medicinal products (IMPs) for clinical studies conducted within Europe. Studies which are directly supported by GMP-compliant on-site manufacturing facilities add substantial value by significantly cutting costs and timelines through proven, efficiency-focused processes.
Predicting Screen Failure Rates of Human Abuse Potential Studies
Human Abuse Potential (HAP) studies are required for New Drug Approvals of all drugs that have a potential psychoactive effect. The steps of…
Oral Abuse Potential of Benzhydrocodone, a Novel Prodrug of Hydrocodone
Hydrocodone bitartrate (HB) and acetaminophen (APAP) combination products are known to be abused via oral, intranasal, and intravenous…
Targeting Patients In A Complex Phase II Rheumatoid Arthritis Study
Targeting Patients In A Complex Phase IIa Rheumatoid Arthritis Study.