Clinical Pharmacokinetic Registration File for Nda and Anda Procedures

The Rietveld Method as a Tool to Quantify the Amorphous Amount of Microcrystalline Cellulose

“…In this context, it is essential that during the research/development of formulations, one can be able to select the correct polymorphic form of an active pharmaceutical ingredient as well as excipients that do not suffer any kind of interaction, ensuring that both bioavailability and the pharmacological effect take place. Thus, the research of polymorphism in pharmaceuticals and excipients is one of the most important subjects to be considered prior to the production of medicaments, mainly because the lack of knowledge of different crystalline forms can influence the production procedure and may bring health problems to patients and financial losses to their manufacturers …”

Open Questions on Bioequivalence: An Updated Reappraisal

“…In addition, in rare cases, it could be the result of substandard pharmaceutical procedures, set up many years ago with the reference [9,23]. In case the latter observation is true, the use of a new formulation prepared according to more accurate and modern techniques can produce pharmacokinetic data with less dispersion than older formulations.…”

“…However, in current bioequivalence trials the enantioselective bioassay is in most cases neglected [23], due to the difficulty and the relatively high costs involved in setting up and validating this kind of methods, mainly for substances active at low concentrations [75]. Typical examples areagonists, which are administered at low doses and are active at very low plasma concentrations [75].…”

Prerequisites for Phase I and II Clinical Drug Trials in Human

“…Major new developments in pharmaceutical technology which have produced controlled-release delivery systems and the market introduction of generics would never have occurred but for the active contribution of pharmacokinetics [2].…”