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Applications of Cli...
Applications of Clinically Relevant Dissolution Testing : Workshop Summary Report
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- Suarez-Sharp, Sandra (författare)
- US FDA, Div Biopharmaceut, Off New Drug Prod, Off Pharmaceut Qual,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA
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- Cohen, Michael (författare)
- Pfizer Inc, Eastern Point Rd, Groton, CT 06340 USA
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- Kesisoglou, Filippos (författare)
- Merck & Co Inc, Pharmaceut Sci, 770 Sumneytown Pike, West Point, PA 19486 USA
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- Abend, Andreas (författare)
- Merck & Co Inc, Pharmaceut Sci, 770 Sumneytown Pike, West Point, PA 19486 USA
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- Marroum, Patrick (författare)
- Abbvie Inc, 1 North Waukegan Rd North, Chicago, IL 60064 USA
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- Delvadia, Poonam (författare)
- US FDA, Div Biopharmaceut, Off New Drug Prod, Off Pharmaceut Qual,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA
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- Kotzagiorgis, Evangelos (författare)
- EMA, Specialized Disciplines Dept, Human Med Res & Dev Support Div, 30 Churchill Pl, London E14 5EU, England
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- Li, Min (författare)
- US FDA, Div Biopharmaceut, Off New Drug Prod, Off Pharmaceut Qual,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA
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- Nordmark, Anna (författare)
- MPA, Dept Efficacy & Safety 2, Uppsala, Sweden
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- Bandi, Nagesh (författare)
- Merck & Co Inc, Pharmaceut Sci, 770 Sumneytown Pike, West Point, PA 19486 USA
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- Sjögren, Erik, 1977- (författare)
- Uppsala universitet,Institutionen för farmaci,Pharmetheus, S-75237 Uppsala, Sweden
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- Babiskin, Andrew (författare)
- US FDA, Div Quantitat Methods & Modeling, Off Res & Stand, Off Gener Drugs, Silver Spring, MD USA
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- Heimbach, Tycho (författare)
- Novartis Pharmaceut, One Hlth Plaza, E Hanover, NJ 07936 USA
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- Kijima, Shinichi (författare)
- PMDA, Adv Review Elect Data Promot Grp, Tokyo, Japan
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- Mandula, Haritha (författare)
- US FDA, Div Biopharmaceut, Off New Drug Prod, Off Pharmaceut Qual,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA
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- Raines, Kimberly (författare)
- US FDA, Div Biopharmaceut, Off New Drug Prod, Off Pharmaceut Qual,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA
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- Seo, Paul (författare)
- US FDA, Div Biopharmaceut, Off New Drug Prod, Off Pharmaceut Qual,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA
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- Zhang, Xinyuan (författare)
- US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA
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(creator_code:org_t)
- 2018-08-27
- 2018
- Engelska.
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Ingår i: AAPS Journal. - : SPRINGER. - 1550-7416. ; 20:6
- Relaterad länk:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- This publication summarizes the proceedings of day 3 of a 3-day workshop on "Dissolution and Translational Modeling Strategies Enabling Patient-Centric Product Development." Specifically, this publication discusses the current approaches in building clinical relevance into drug product development for solid oral dosage forms, along with challenges that both industry and regulatory agencies are facing in setting clinically relevant drug product specifications (CRDPS) as presented at the workshop. The concept of clinical relevance is a multidisciplinary effort which implies an understanding of the relationship between the critical quality attributes (CQAs) and their impact on predetermined clinical outcomes. Developing this level of understanding, in many cases, requires introducing deliberate but meaningful variations into the critical material attributes (CMAs) and critical process parameters (CPPs) to establish a relationship between the resulting in vitro dissolution/release profiles and in vivo PK performance, a surrogate for clinical outcomes. Alternatively, with the intention of improving the efficiency of the drug product development process by limiting the burden of conducting in vivo studies, this understanding can be either built, or at least enhanced, through in silico efforts, such as IVIVC and physiologically based pharmacokinetic (PBPK) absorption modeling and simulation (M&S). These approaches enable dissolution testing to establish safe boundaries and reject drug product batches falling outside of the established safe range (e.g., due to inadequate in vivo performance) enabling the method to become clinically relevant. Ultimately, these efforts contribute towards patient-centric drug product development and allow regulatory flexibility throughout the lifecycle of the drug product.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Farmakologi och toxikologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Pharmacology and Toxicology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Farmaceutiska vetenskaper (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Pharmaceutical Sciences (hsv//eng)
Nyckelord
- clinically relevant specifications
- dissolution
- IVIVC/IVIVR
- PBPK absorption modeling and simulation
- safe space
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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Till lärosätets databas
- Av författaren/redakt...
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Suarez-Sharp, Sa ...
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Cohen, Michael
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Kesisoglou, Fili ...
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Abend, Andreas
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Marroum, Patrick
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Delvadia, Poonam
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visa fler...
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Kotzagiorgis, Ev ...
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Li, Min
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Nordmark, Anna
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Bandi, Nagesh
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Sjögren, Erik, 1 ...
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Babiskin, Andrew
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Heimbach, Tycho
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Kijima, Shinichi
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Mandula, Haritha
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Raines, Kimberly
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Seo, Paul
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Zhang, Xinyuan
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