The AAPS journal

AAPS J · ISSN (e) 1550-7416 · 10 papers in corpus
other 2023
doi:10.1208/s12248-023-00794-6 ·PMID:36949256

In lieu of large bioequivalence studies and exposing healthy postmenopausal women to additional drug exposure for elagolix coadministered with hormonal add-back therapy, physiologically based pharmacokinetic (PBPK) modeling was used with in…

review 2021
doi:10.1208/s12248-021-00602-z ·PMID:33973067

Bacterial vaginosis (BV) is one of the most common vaginal infections that affects hundreds of millions of women of reproductive age, worldwide. Traditional treatment strategies, such as oral and topical antibiotics, have shown efficacy aga…

lab-animal 2015
doi:10.1208/s12248-015-9769-x ·PMID:25956382

The enzymatic stability, antitumor activity, and gonadotropin stimulatory effects of glycosylated luteinizing hormone-releasing hormone (LHRH) analogs were investigated in this study. Conjugation of carbohydrate units, including lactose (La…

review 2015
doi:10.1208/s12248-014-9687-3 ·PMID:25366889

Development of peptide drugs is challenging but also quite rewarding. Five blockbuster peptide drugs are currently on the market, and six new peptides received first marketing approval as new molecular entities in 2012. Although peptides on…

lab-animal 2014
doi:10.1208/s12248-013-9559-2 ·PMID:24442753

Mifepristone (RU486) is marketed and used widely by women as an abortifacient, and experimentally for psychotic depression and anticancer treatments. After administration, metapristone is found to be the most predominant metabolite of mifep…

review 2012
doi:10.1208/s12248-011-9307-4 ·PMID:22105442

Absorption enhancers are functional excipients included in formulations to improve the absorption of a pharmacologically active drug. The term absorption enhancer usually refers to an agent whose function is to increase absorption by enhanc…

nonrandomized-trial 2011
doi:10.1208/s12248-011-9304-7 ·PMID:22028249

Telapristone is a selective progesterone antagonist that is being developed for the long-term treatment of symptoms associated with endometriosis and uterine fibroids. The population pharmacokinetics of telapristone (CDB-4124) and CDB-4453 …

review 2010
doi:10.1208/s12248-009-9156-6 ·PMID:19921439

Drug product specifications are a critical element of a good control strategy. Parenteral microsphere products are complex dosage forms, requiring careful development of test methods and acceptance criteria for the specifications. In partic…

review 2010
doi:10.1208/s12248-010-9203-3 ·PMID:20458565

Simulation of gastrointestinal conditions is essential to adequately predict the in vivo behavior of drug formulations. To reduce the size and number of human studies required to identify a drug product with appropriate performance in both …

review 2009
doi:10.1208/s12248-009-9081-8 ·PMID:19199044

The reduced injection frequency and more nearly constant serum concentrations afforded by sustained release devices have been exploited for the chronic delivery of several therapeutic peptides via poly(lactide-co-glycolide) (PLG) microspher…