Pre-clinical Efficacy and Safety Pharmacology of PEGylated Recombinant Human Endostatin
CONCLUSION: On the basis of the pre-clinical efficacy and safety pharmacology data of M2ES, M2ES can be authorized to carry out further clinical studies.PMID:36999708 | DOI:10.2174/1566524023666230331091757 (Source: Cancer Control)
Source: Cancer Control - March 31, 2023 Category: Cancer & Oncology Authors: Lifang Guo Linbin Hua Bin Hu Jing Wang Source Type: research
Pre-clinical Efficacy and Safety Pharmacology of PEGylated Recombinant Human Endostatin
CONCLUSION: On the basis of the pre-clinical efficacy and safety pharmacology data of M2ES, M2ES can be authorized to carry out further clinical studies.PMID:36999708 | DOI:10.2174/1566524023666230331091757 (Source: Current Molecular Medicine)
Source: Current Molecular Medicine - March 31, 2023 Category: Molecular Biology Authors: Lifang Guo Linbin Hua Bin Hu Jing Wang Source Type: research
Pre-clinical Efficacy and Safety Pharmacology of PEGylated Recombinant Human Endostatin
CONCLUSION: On the basis of the pre-clinical efficacy and safety pharmacology data of M2ES, M2ES can be authorized to carry out further clinical studies.PMID:36999708 | DOI:10.2174/1566524023666230331091757 (Source: Molecular Medicine)
Source: Molecular Medicine - March 31, 2023 Category: Molecular Biology Authors: Lifang Guo Linbin Hua Bin Hu Jing Wang Source Type: research
Pre-clinical Efficacy and Safety Pharmacology of PEGylated Recombinant Human Endostatin
CONCLUSION: On the basis of the pre-clinical efficacy and safety pharmacology data of M2ES, M2ES can be authorized to carry out further clinical studies.PMID:36999708 | DOI:10.2174/1566524023666230331091757 (Source: Current Molecular Medicine)
Source: Current Molecular Medicine - March 31, 2023 Category: Molecular Biology Authors: Lifang Guo Linbin Hua Bin Hu Jing Wang Source Type: research
Pre-clinical Efficacy and Safety Pharmacology of PEGylated Recombinant Human Endostatin
CONCLUSION: On the basis of the pre-clinical efficacy and safety pharmacology data of M2ES, M2ES can be authorized to carry out further clinical studies.PMID:36999708 | DOI:10.2174/1566524023666230331091757 (Source: Current Molecular Medicine)
Source: Current Molecular Medicine - March 31, 2023 Category: Molecular Biology Authors: Lifang Guo Linbin Hua Bin Hu Jing Wang Source Type: research
Pre-clinical Efficacy and Safety Pharmacology of PEGylated Recombinant Human Endostatin
CONCLUSION: On the basis of the pre-clinical efficacy and safety pharmacology data of M2ES, M2ES can be authorized to carry out further clinical studies.PMID:36999708 | DOI:10.2174/1566524023666230331091757 (Source: Current Molecular Medicine)
Source: Current Molecular Medicine - March 31, 2023 Category: Molecular Biology Authors: Lifang Guo Linbin Hua Bin Hu Jing Wang Source Type: research
Pre-clinical Efficacy and Safety Pharmacology of PEGylated Recombinant Human Endostatin
CONCLUSION: On the basis of the pre-clinical efficacy and safety pharmacology data of M2ES, M2ES can be authorized to carry out further clinical studies.PMID:36999708 | DOI:10.2174/1566524023666230331091757 (Source: Current Molecular Medicine)
Source: Current Molecular Medicine - March 31, 2023 Category: Molecular Biology Authors: Lifang Guo Linbin Hua Bin Hu Jing Wang Source Type: research
Pre-clinical Efficacy and Safety Pharmacology of PEGylated Recombinant Human Endostatin
CONCLUSION: On the basis of the pre-clinical efficacy and safety pharmacology data of M2ES, M2ES can be authorized to carry out further clinical studies.PMID:36999708 | DOI:10.2174/1566524023666230331091757 (Source: Current Molecular Medicine)
Source: Current Molecular Medicine - March 31, 2023 Category: Molecular Biology Authors: Lifang Guo Linbin Hua Bin Hu Jing Wang Source Type: research
A mass balance study of [14C]SHR6390 (dalpiciclib), a selective and potent CDK4/6 inhibitor in humans
SHR6390 (dalpiciclib) is a selective and effective cyclin-dependent kinase (CDK) 4/6 inhibitor and an effective cancer therapeutic agent. On 31 December 2021, the new drug application was approved by National Medical Product Administration (NMPA). The metabolism, mass balance, and pharmacokinetics of SHR6390 in 6 healthy Chinese male subjects after a single oral dose of 150 mg [14C]SHR6390 (150 µCi) in this research. The Tmax of SHR6390 was 3.00 h. In plasma, the t1/2 of SHR6390 and its relative components was approximately 17.50 h. The radioactivity B/P (blood-to-plasma) AUC0-t ratio was 1.81, indicating the preferen...
Source: Frontiers in Pharmacology - March 31, 2023 Category: Drugs & Pharmacology Source Type: research
Drug Development for New Psychiatric Drug Therapies
Adv Neurobiol. 2023;30:131-167. doi: 10.1007/978-3-031-21054-9_5.ABSTRACTDrug development is an expensive, high risk, and highly regulated process. Only about 6.2% of new molecules tested for mental disorders eventually achieve Food and Drug Administration (FDA) approval. New molecular entities are produced, and extensive in vitro animal testing is performed before they are evaluated in humans. The compound is used in animals to predict clinical effects in humans, and studies addressing pharmacodynamics, pharmacokinetics, toxicology, and mutagenicity are conducted. Human research proceeds in three stages with the ultimate ...
Source: Adv Data - March 17, 2023 Category: Epidemiology Authors: M Lynn Crismon Janet Walkow Roger W Sommi Source Type: research
Drug Development for New Psychiatric Drug Therapies
Adv Neurobiol. 2023;30:131-167. doi: 10.1007/978-3-031-21054-9_5.ABSTRACTDrug development is an expensive, high risk, and highly regulated process. Only about 6.2% of new molecules tested for mental disorders eventually achieve Food and Drug Administration (FDA) approval. New molecular entities are produced, and extensive in vitro animal testing is performed before they are evaluated in humans. The compound is used in animals to predict clinical effects in humans, and studies addressing pharmacodynamics, pharmacokinetics, toxicology, and mutagenicity are conducted. Human research proceeds in three stages with the ultimate ...
Source: Adv Data - March 17, 2023 Category: Epidemiology Authors: M Lynn Crismon Janet Walkow Roger W Sommi Source Type: research
The Prevalence of Several Treatments in Preventing the Back Conversion of Acyl Glucuronide Metabolites in Abbreviated New Drug Applications
The objective of this study was to investigate the impact of back conversion of acyl glucuronide metabolites on drug concentration measurement in bioequivalence (BE) studies submitted to Abbreviated New Drug Applications (ANDAs). The prevalence of several treatments for preventing the back conversion of acyl glucuronide metabolites and the results of incurred sample reanalysis (ISR) were analyzed. In total, 322 ANDAs for 26 drugs known to generate acyl glucuronide metabolites were surveyed. Many studies have applied multiple preventive treatments during the clinical and bioanalytical phases. More than two-thirds (67.2%) of...
Source: The AAPS Journal - March 1, 2023 Category: Drugs & Pharmacology Source Type: research
FDA Advisory Panel Recommends Approval for Over-the-Counter Narcan
Last week the U.S. Food and Drug Administration (FDA) Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee voted unanimously, 19-0, to recommend that Narcan (naloxone HCl) 4 mg nasal spray be made available without a prescription, Emergent BioSolutionsannounced. The medication reverses an opioid overdose by blocking the effects of opioids.The FDA is not bound by the committees ’ guidance but will take their advice into consideration when it makes its decision on whether to make the drug available over the counter (OTC). If approved, Narcan would be the first OTC nalox...
Source: Psychiatr News - February 21, 2023 Category: Psychiatry Tags: Food and Drug Administration naloxone narcan opioid overdose over-the-counter STAT Source Type: research
Neural text generation in regulatory medical writing
Conclusion: The results of this study indicate that a heuristic approach to generating inputs for an abstractive summarization model increased ROUGE scores, compared to a global or manual approach when automatically generating biomedical text. Such methods hold the potential to significantly reduce the manual labor burden in medical writing and related disciplines. (Source: Frontiers in Pharmacology)
Source: Frontiers in Pharmacology - February 10, 2023 Category: Drugs & Pharmacology Source Type: research
Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview
AbstractOn September 30 and October 1, 2021, the US Food and Drug Administration (FDA) and the Center for Research on Complex Generics cosponsored a live virtual workshop titled “Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches.” The overall aims of the workshop included (i) engaging the generic drug industry and other involved stakeholders regarding how mechanistic modeling and simulation can support their product development and regulatory submissions; (ii) sharing the current state of mechanistic modeling for bioequivalence (BE) assessment through case studies; (iii) establ...
Source: CPT: Pharmacometrics and Systems Pharmacology - February 6, 2023 Category: Drugs & Pharmacology Authors: Andrew Babiskin,
Fang Wu,
Youssef Mousa,
Ming ‐Liang Tan,
Eleftheria Tsakalozou,
Ross L. Walenga,
Miyoung Yoon,
Sam G. Raney,
James E. Polli,
Anna Schwendeman,
Vishalakshi Krishnan,
Lanyan Fang,
Liang Zhao Tags: MINI REVIEW Source Type: research
