Literature DB >> 8456084

Scaleup of immediate release oral solid dosage forms.

J P Skelly, G A Van Buskirk, D R Savello, G L Amidon, H M Arbit, S Dighe, M B Fawzi, M A Gonzalez, A W Malick, H Malinowski.   

Abstract

Keywords:  NASA Discipline Regulatory Physiology; Non-NASA Center

Mesh：

Substances：

Year:  1993        PMID： 8456084     DOI： 10.1023/a:1018915700942

Source DB:  PubMed          Journal:  Pharm Res        ISSN： 0724-8741            Impact factor:   4.200


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  5 in total

1.  Survey: calculation of the characteristics of oral diffusion-controlled release dosage forms related to the drug.

Authors:  I D Rosca; J M Vergnaud
Journal:  Eur J Drug Metab Pharmacokinet       Date:  2010-09       Impact factor: 2.441

2.  A history of biopharmaceutics in the Food and Drug Administration 1968-1993.

Authors:  Jerome Philip Skelly
Journal:  AAPS J       Date:  2009-11-20       Impact factor: 4.009

Review 3.  In vitro/in vivo correlations in biopharmaceutics: scientific and regulatory implications.

Authors:  J P Skelly; G F Shiu
Journal:  Eur J Drug Metab Pharmacokinet       Date:  1993 Jan-Mar       Impact factor: 2.441

Review 4.  Best practices for the development, scale-up, and post-approval change control of IR and MR dosage forms in the current quality-by-design paradigm.

Authors:  Glenn A Van Buskirk; Satish Asotra; Christopher Balducci; Prabir Basu; Gerald DiDonato; Angelica Dorantes; W Mark Eickhoff; Tapash Ghosh; Mario A González; Theresa Henry; Matthew Howard; Jason Kamm; Steven Laurenz; Ryan MacKenzie; Richard Mannion; Patrick K Noonan; Terrance Ocheltree; Umesh Pai; Richard P Poska; Michael L Putnam; Ramani R Raghavan; Colleen Ruegger; Eric Sánchez; Vinod P Shah; Zezhi Jesse Shao; Russell Somma; Vijay Tammara; Avinash G Thombre; Bruce Thompson; Robert J Timko; Satyam Upadrashta; Sivakumar Vaithiyalingam
Journal:  AAPS PharmSciTech       Date:  2014-03-01       Impact factor: 3.246

5.  Scale-up effects on dissolution and bioavailability of propranolol hydrochloride and metoprolol tartrate tablet formulations.

Authors:  N D Eddington; G S Rekhi; L J Lesko; L L Augsburger
Journal:  AAPS PharmSciTech       Date:  2000-06-17       Impact factor: 3.246
  5 in total

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