P
Patrick J. Marroum
Researcher at AbbVie
Publications - 38
Citations - 1920
Patrick J. Marroum is an academic researcher from AbbVie. The author has contributed to research in topics: Dissolution testing & Bioequivalence. The author has an hindex of 19, co-authored 33 publications receiving 1737 citations. Previous affiliations of Patrick J. Marroum include Silver Spring Networks & Food and Drug Administration.
Papers
More filters
Journal ArticleDOI
FIP/AAPS guidelines to dissolution/in vitro release testing of novel/special dosage forms
Martin Siewert,Jennifer B. Dressman,Cynthia K. Brown,Vinod P. Shah,Jean-Marc Aiache,Nobuo Aoyagi,Dennis Bashaw,Cynthia Brown,William Brown,Diane J. Burgess,John R. Crison,Patrick P. DeLuca,Ruzica Djerki,Thomas C. Foster,Kirsti Gjellan,Vivian A. Gray,Ajaz S. Hussain,Tom Ingallinera,James Klancke,Johannes Kraemer,Henning G. Kristensen,Kofi Kumi,Christian Leuner,Jobst Limberg,Petra Loos,Lenny Margulis,Patrick J. Marroum,Helga Moeller,Bernd W. Mueller,Martin Mueller-Zsigmondy,Ngozi Okafo,Larry Ouderkirk,Shravan Parsi,Saeed Qureshi,Joseph R. Robinson,Vinod P. Shah,Ramana S. Uppoor,Roger Williams +37 more
TL;DR: This study presents a meta-analysis of the phytochemical properties of seven novel drugs that have been developed over a period of several years and show promise in terms of protecting against adverse events and promoting drug safety.
Journal ArticleDOI
New Era in Drug Interaction Evaluation: US Food and Drug Administration Update on CYP Enzymes, Transporters, and the Guidance Process
Shiew-Mei Huang,John M. Strong,Lei Zhang,Kellie S. Reynolds,Srikanth Nallani,Robert Temple,Sophia Abraham,Sayed Al Habet,Raman K. Baweja,Gilbert J. Burckart,Sang Chung,Philip Colangelo,David M. Frucht,Martin D. Green,Paul Hepp,Elena Karnaukhova,Hon Sum Ko,Jang Ik Lee,Patrick J. Marroum,Janet Norden,Wei Qiu,Atiqur Rahman,Solomon Sobel,Toni Stifano,Kenneth E. Thummel,Xiao Xiong Wei,Sally Yasuda,Jenny H. Zheng,H Zhao,Lawrence J. Lesko +29 more
TL;DR: A comprehensive overview of the evolution of the drug interaction guidances, including a synopsis of the steps taken by the FDA to revise the original drug interaction guidance documents, and summarizes and highlights updated sections in the current guidance document.
Journal ArticleDOI
Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications.
Venkatesh A. Bhattaram,Brian Booth,Roshni Ramchandani,B. Nhi Beasley,Yaning Wang,Veneeta Tandon,John Duan,Raman K. Baweja,Patrick J. Marroum,Ramana S. Uppoor,Nam Atiqur Rahman,Chandrahas G. Sahajwalla,J. Robert Powell,Mehul Mehta,Jogarao V. S. Gobburu +14 more
TL;DR: Assessment of the role of pharmacometrics at the US Food and Drug Administration in making drug approval and labeling decisions finds the need for early interaction between the FDA and sponsors to plan the development more efficiently by appreciating the regulatory expectations better.
Journal ArticleDOI
FDA Guidance for Industry 1 Extended Release Solid Oral Dosage forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations
H. Malinowski,Patrick J. Marroum,Venkata Ramana Uppoor,William R. Gillespie,Hae-Young Ahn,Peter Lockwood,James Henderson,Raman K. Baweja,Mohammad Awlad Hossain,Nicholas Fleischer,Lloyd G. Tillman,Ajaz S. Hussain,Vinod P. Shah,Angelica Dorantes,Ray Zhu,He Sun,Kofi Kumi,Stella Machado,Vijaya Tammara,Ting Eng Ong-Chen,Houda Mahayni,Lawrence J. Lesko,Roger Williams +22 more