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Olena Gligorich
Olena brings over 16 years of business and biotechnology industry leadership experience to advise companies on how to achieve their goals through directing decision making and impeccable...
https://cmkc.usp.org/members/2480
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Understanding pharmaceutical quality by design
Contributor(s):: Yu, Lawrence X, Amidon, Gregory Khan, Mansoor A Hoag, Stephen W, Polli, James, Raju, G K, Woodcock, Janet
This review further clarifies the concept of pharmaceutical quality by design (QbD) and describes its objectives. QbD elements include the following: (1) a quality target product profile (QTPP) that identifies the critical quality attributes (CQAs) of the drug product; (2) product design and...
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Process analytical technology in continuous manufacturing of a commercial pharmaceutical product
Contributor(s):: Vargas, Jenny, Nielsen, Sarah, Cárdenas, Vanessa, Gonzalez, Anthony, Aymat, Efrain, Almodovar, Elvin, Classe, Gustavo, Colón, Yleana, Sanchez, Eric, Romañach, Rodolfo
The implementation of process analytical technology and continuous manufacturing at an FDA approved commercial manufacturing site is described. In this direct compaction process the blends produced were monitored with a Near Infrared (NIR) spectroscopic calibration model developed with partial...
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Material Properties and Compressibility Using Heckel and Kawakita Equation with Commonly Used Pharmaceutical Excipients
Contributor(s):: Choi, Du-Hyung, Kim, Nam-Ah Chu, Kyung-Rok Jung, Youn-Jung, Yoon, Jeong-Hyun, Jeong, Seong-Hoon
This study investigated basic material properties and compressibility of commonly used pharmaceutical excipients. Five classes of excipients are selected including starch, lactose, calcium phosphate, microcrystalline cellulose (MCC), and povidone. The compressibility was evaluated using...