- NLM Digital Collections - Amino Acid Residues Essential for Biological Activity of a Peptide Derived From a Major ...Publication: National Academy Press (U.S.), 1993... cell surfaces consequent to inhibition of receptor and transporter internalization (1-3). Dk-(61-85) is active only if it has assumed an ordered conformation prior to its interaction with cells (2). The initial findings were with ...
- NLM Digital Collections - In vitro drug interaction studies : cytochrome P-450 enzyme- and transporter-mediated drug ...Publication: Silver Spring, MD : Center for Drug Evaluation and Research, January 2020... Induction Working Group in Response to Drug-Drug Interaction Guidances From ... the Renal Active Tubular Secretion of Creatinine and Mechanism for Serum ...
- NLM Digital Collections - Drug products, including biological products, that contain nanomaterialsPublication: Silver Spring, MD : Center for Drug Evaluation and Research, April 2022... enzymes or eliminated unchanged in the urine. The interaction of active ... Therefore, experimental evidence supporting or rejecting this notion ...
- NLM Digital Collections - Acute myeloid leukemia developing drugs and biological products for treatment : guidance for ....Publication: Silver Spring, MD : Center for Drug Evaluation and Research, October 2022... elimination pathways of the parent drug and its active metabolites. If ... Transporter- Mediated Drug Interactions Guidance for Industry (January 2020). ...
- NLM Digital Collections - Clinical drug interaction studies : cytochrome P450 enzyme- and transporter-mediated drug ...Publication: Silver Spring, MD : Center for Drug Evaluation and Research, January 2020... FDA’s Web site for Drug Development and Drug Interactions as transporter substrates, inducers, or inhibitors cannot be considered as ... clinical DDI studies that investigate the effects of transporter interactions are considered concomitant-use studies. See section IV. ...
- NLM Digital Collections - Chronic hepatitis B virus infection : developing drugs for treatmentPublication: Silver Spring, MD : Center for Drug Evaluation and Research, April 2022... Clinical Drug Interaction Studies-Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions (January 2020), In Vitro Drug Interaction Studies-Cytochrome ...
- NLM Digital Collections - Evaluation of gastric pH-dependent drug interactions with acid-reducing agents : study design,...Publication: Silver Spring, MD : Center for Drug Evaluation and Research, March 2023... Clinical Drug Interaction Studies – Cytochrome P450 Enzymes and Transporters-Mediated Drug Interactions (January 2020). We update guidances periodically. For the ...
- NLM Digital Collections - Rare diseases : considerations for the development of drugs and biological products : ...Publication: Silver Spring, MD : Center for Drug Evaluation and Research, December 2023... Vitro Drug Interaction Studies – Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions (January 2020), Clinical Drug Interaction Studies – Cytochrome P450 ...
- NLM Digital Collections - Development of anti-infective drug products for the pediatric populationPublication: Silver Spring, MD : Center for Drug Evaluation and Research, December 2021... Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter- Mediated Drug Interactions (January 2020). 6 Contains Nonbinding Recommendations Existing animal ...
- NLM Digital Collections - Expansion cohorts : use in first-in-human clinical trials to expedite development of oncology ...Publication: Silver Spring, MD : Center for Drug Evaluation and Research, March 2022... Clinical Drug Interaction Studies - Cytochrome P450 Enzyme and Transporter-Mediated Drug Interactions (January 2020) D. Further Dose/Schedule Exploration Sponsors ...
57 results