Understanding Human ADME
ADME (Absorption, Distribution, Metabolism, Excretion) is the acronym that has been used for decades to describe studies that address what happens to the drug molecule itself when it is administered to humans and animals used in toxicology assessments. The strategic question for drug developers is how much knowledge about human ADME is needed or valuable at different stages of clinical development. Read more.
ADME Studies in Early Clinical Development: Addressing MIST
As discussed in the introductory section of this newsletter, “Understanding Human ADME”, the timing of human ADME studies is shifting earlier in the clinical development of a new drug. Part of the impetus for this shift can be attributed to the 2002 landmark publication of PhRMA/FDA recommendations on the safety assessment of circulating drug metabolites1. Read more.
Understanding the Benefits of On-Site Extemporaneous Sterile Compounding in a USP <797> Clean Room
USP <797> refers to chapter 797 “Pharmaceutical Compounding–Sterile Preparations”, in the USP National Formulary. It is the first set of enforceable sterile compounding standards issued by the United States Pharmacopeia (USP). Read more.
Overview: ADME Services
In response to a growing interest in conducting human 14C-radiolabeled ADME studies earlier in drug development, Celerion has expanded and renovated its ADME suite in Lincoln, Nebraska. As discussed in the section on “ADME Studies in Early Clinical Development: Addressing MIST”, client demand for conducting human 14C ADME studies has continued to increase since the issuance of the MIST (Metabolites in Safety Testing) guidances from the FDA and ICH. Read more.
Malle Jurima-Romet, Ph.D., Senior Director, Drug Development
Dr. Jurima-Romet has 25 years of biomedical and pharmaceutical research experience, with a focus on drug metabolism. She earned her Ph.D. in pharmacology from the University of Toronto where her doctoral research was in the field of pharmacogenetics. Read more.
Lincoln Facility Overview
Celerion’s corporate headquarters in Lincoln, Nebraska has a long history in the local community having conducted the first clinical study in 1969. The facility has an on-site Phase I clinic, bioanalytical laboratory, and scientists focused on comprehensive PK/PD, statistics and data management. Read more.