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New era in bioequivalence global harmonization through ICH M13 initiative: critical review on new concepts, alternative approaches for high-risk products.

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Title: New era in bioequivalence global harmonization through ICH M13 initiative: critical review on new concepts, alternative approaches for high-risk products.
Authors: Khan, Mohammed Shareef1 (AUTHOR), Khan, Sohel Mohammed2 (AUTHOR), Martins, Frederico Severino3 (AUTHOR), Boddu, Rajkumar1 (AUTHOR), Saini, Anuj Kumar1,2 (AUTHOR), Kollipara, Sivacharan1 (AUTHOR) sivacharankollipara@drreddys.com
Source: Xenobiotica. Jun2025, Vol. 55 Issue 6, p464-477. 14p.
Database: Environment Complete
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RecordInfo BibRecord:
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        Value: 10.1080/00498254.2025.2535415
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        Text: English
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        PageCount: 14
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      – TitleFull: New era in bioequivalence global harmonization through ICH M13 initiative: critical review on new concepts, alternative approaches for high-risk products.
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            – D: 01
              M: 06
              Text: Jun2025
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              Y: 2025
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