Challenges and opportunities in the development of complex generic long-acting injectable drug products.

Autor: O'Brien MN; Pfizer, Inc., Worldwide Research, Development, & Medical, 375 N Field Dr., Lake Forest, IL 60045, USA. Electronic address: obrienlm@gene.com., Jiang W; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA. Electronic address: wenlei.jiang@fda.hhs.gov., Wang Y; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA., Loffredo DM; Pfizer, Inc., Worldwide Research, Development, & Medical, 375 N Field Dr., Lake Forest, IL 60045, USA.

Publikováno v: Journal of controlled release : official journal of the Controlled Release Society [J Control Release] 2021 Aug 10; Vol. 336, pp. 144-158. Date of Electronic Publication: 2021 Jun 11.

Tricaprylin‐based drug crystalline suspension for intramuscular long‐acting delivery of entecavir with alleviated local inflammation.

Autor: Jeong, Min Young¹ (AUTHOR), Ho, Myoung Jin¹ (AUTHOR), Park, Joon Soo¹ (AUTHOR), Jeong, Hoetaek¹ (AUTHOR), Kim, Jin Hee¹ (AUTHOR), Jang, Yong Jin¹ (AUTHOR), Shin, Doe Myung¹ (AUTHOR), Yang, In Gyu¹ (AUTHOR), Kim, Hye Rim¹ (AUTHOR), Song, Woo Heon¹ (AUTHOR), Lee, Sangkil² (AUTHOR), Song, Seh Hyon³ (AUTHOR), Choi, Yong Seok¹ (AUTHOR), Han, Young Taek¹ (AUTHOR), Kang, Myung Joo¹ (AUTHOR) kangmj@dankook.ac.kr

Publikováno v: Bioengineering & Translational Medicine. Jul2024, Vol. 9 Issue 4, p1-18. 18p.

Risk Assessment of Failures in Generic Drug Development and Approval Procedure under Competitive Generic Drug Therapy and Patent Challenge Exclusivities Provided by the United States Food and Drug Administration.

Autor: Reddy, M Vivek¹ (AUTHOR), Ganesh, GNK¹ (AUTHOR) gnk@jssuni.edu.in, Babu, B² (AUTHOR), Jagadeesan, Ramesh³ (AUTHOR), MR, Praharsh Kumar⁴ (AUTHOR)

Publikováno v: Acta Marisiensis. Seria Medica. Mar2022, Vol. 68 Issue 1, p28-34. 7p.

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