Publications & Comments

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407 total entries

Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment; Draft Guidance for Industry

Date of Publication: September 16, 2021

Author(s): DruSafe LG

Docket # FDA-2015-D-1246-0001 (http://www.regulations.gov/#!documentDetail;D=FDA-2015-D-1246-0001)

Agency: FDA

Guideline on the Evaluation of the Pharmacokinetics of Medicinal Products in Patients with Decreased Renal Function

Date of Publication: September 16, 2021

Author(s): CPLG

Docket # EMA/83874/2014 (https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-evaluation-pharmacokinetics-medicinal-products-patients-de)

Agency: EMA

Comments on 'Concept Paper on the Revision of the ‘Guideline on Strategies to Identify and Mitigate Risks for First-in-Human Clinical Trials with Investigational Medicinal Products’

Date of Publication: September 16, 2021

Author(s): CPLG, DMLG, DruSafe

Docket # EMEA/CHMP/SWP/28367/07 (https://www.ema.europa.eu/documents/scientific-guideline/guideline-strategies-identify-mitigate-risks-first-human-early-clinical)

Agency: EMA

Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product

Date of Publication: September 16, 2021

Author(s): CPLG

Docket # FDA-2014-D-0234-0028 (http://www.regulations.gov/#!documentDetail;D=FDA-2014-D-0234-0028)

Agency: FDA

Evaluation of a New Molecular Entity as a Victim of Metabolic Drug-Drug Interactions - an Industry Perspective Drug Metabolism and Disposition

Date of Publication: September 16, 2021

Author(s): Tonika Bohnert, Aarti Patel, Ian Templeton, Yuan Chen, Chuang Lu, George Lai, Louis Leung, Susanna Tse, Heidi J Einolf, Ying-Hong Wang, Michael Sinz, Ralph Stearns, Robert Walsky, Wanping Geng, Sirimas Sudsakorn, David Moore, Ling He, Jan Wahlstrom, Jim Keirns, Rangaraj Narayanan, Dieter Lang, Xiaoqing Yang

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