title: Designing a molecular delivery system within a preclinical timeframe.
abstract: An understanding of solid-state chemistry, including polymorphism, can reduce the time to filing an investigative new drug (IND) application. Obtaining a stable formulation for IND studies is crucial and must be the focus of much of the early solid-state chemistry research. Simple formulations such as a chemical substance in capsule (CIC)--the chemical substance can be crystalline or amorphous--are preferable for the IND trial and the solubility/dissolution rate has an important role in manufacturing IND clinical supplies. Two fast-to-IND flowcharts are presented here for exploratory IND and conventional IND. The utilization of quality by design and process analytical chemistry (PAT) concepts at an early stage will lay the foundation for the accelerated development of the medicines that are successful in the IND trials.
authors.affiliation: SSCI (An Aptuit Company), 3065 Kent Avenue, West Lafayette, IN 47906, USA.
authors.forename: Jan-Olav
authors.initials: JO
authors.lastname: Henck
authors.forename: Stephen R
authors.initials: SR
authors.lastname: Byrn
mesh_terms: D002623:Chemistry Techniques, Analytical / Q000379:methods; D003460:Crystallization; D016503:Drug Delivery Systems; D015195:Drug Design; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D004355:Drug Stability; D015507:Drugs, Investigational; D017387:Investigational New Drug Application / Q000379:methods*; D011786:Quality Control; D012985:Software Design; D012995:Solubility; D013678:Technology, Pharmaceutical
chemical_list: D015507:Drugs, Investigational