The Food and Drug Administration's current Good Manufacturing Practices guidelines for the inspection of pharmaceutical quality control laboratories stress the need for explicit standard operating procedure's requirements for retesting criteria and the investigation of specification failures. Out-of-specification results are best handled through a priori procedures for the evaluation of their validity. These procedures should also specify the degree of retesting or resampling permitted. Initial investigations should focus on uncovering apparent laboratory-related or sampling errors. Should this initial investigation prove inconclusive, an expanded investigation should be conducted to uncover any less conspicuous cause, which could include process or operator-dependent as well as analytical errors. A schematic approach to controlling retesting through a rigorous policy of investigating failures, limiting retest analyses, and documenting and reporting all results is described.

1989-12-01·Clinical Pharmacokinetics2区 · 医学

Effects of Age on the Elimination of Labetalol

2区 · 医学

Article

作者: Thomas Valiquett ; Mark A. Sirgo ; Mario L. Rocci

Labetalol is an alpha 1- and beta-adrenergic antagonist currently used in the treatment of hypertension. Studies which have evaluated the effects of age on its pharmacokinetics have yielded conflicting results. The purpose of this study is to comprehensively re-evaluate the effect of age on the elimination of labetalol. Data were obtained from 4 single-dose and 3 multiple-dose studies of the pharmacokinetics of the drug. An analysis of covariance was performed on the single-dose data to determine whether the type of subject evaluated (normotensive vs hypertensive), type of assay methodology used and/or age were significant factors affecting labetalol clearance estimates. A similar covariance procedure was used for the multiple-dose data, to assess whether the type of subject, duration of treatment and/or age were significant variables affecting labetalol elimination. Subsequent to the analysis of covariance, linear regression and correlation analysis was used to evaluate the effects of age on labetalol clearance. A modest though significant relationship was observed between the apparent oral clearance of the drug and age; it appeared slightly stronger when clearance was normalised for bodyweight. No relationship was found following multiple doses of the drug. Hence, age does not appear to be a significant factor affecting the oral clearance of labetalol, particularly in individuals receiving the drug in the long term.

1989-01-01·DICP

Allergic Reaction to Antipyrine, A Marker of Hepatic Enzyme Activity

Article

作者: Rocci, Mario L. ; Mccrea, Jacqueline B. ; Vlasses, Peter H.

Antipyrine is a pyrazole derivative used extensively as a marker for hepatic drug metabolizing enzyme activity. A subject participating in a clinical trial employing antipyrine experienced an acute allergic reaction to the drug which was characterized by diaphoresis, flushing, swelling of the throat, difficulty in breathing, vomiting, swelling of the upper lip, and a diffuse urticarial rash. Intravenous administration of diphenhydramine markedly improved the symptomatology. Clinical investigators as well as study participants should be alerted to the potential for antipyrine to cause an acute allergic reaction.

项与 Oneida Research Services, Inc. 相关的新闻（医药）

2025-02-06

·Endpoints

J&J, Intra-Cellular quickly sealed $14B deal as three others passed on buying the neuro drugmaker

It took one month for Johnson & Johnson to secure its $14 billion acquisition of Intra-Cellular Therapies, according to new securities filings that shed light into the back-and-forth talks behind the biggest biotech buyout of the past 14 months. J&J Innovative Medicine worldwide chair Jennifer Taubert presented Intra-Cellular chair and CEO Sharon Mates with a $115 per-share offer on Dec. 13, according to paperwork filed with the SEC on Wednesday evening. Over the ensuing weeks, execs at Intra-Cellular and J&J hashed out new terms, eventually settling on $132 per share. On Jan. 6, Intra-Cellular’s bankers at Centerview and Jefferies did a quick check to see if three other companies would be interested in acquiring the biotech. Within two days, all three counterparties said they weren’t interested in buying Intra-Cellular, according to the SEC filing. J&J came knocking on Intra-Cellular’s doors just days after the New Jersey biotech said it asked the FDA to expand the label of its bipolar depression and schizophrenia drug Caplyta to include major depressive disorder. The drug, first approved in December 2019, reeled in $175 million in sales in the third quarter of 2024, a 39% jump over the same period of 2023. It’s expected to hit $5 billion in peak sales, according to Leerink Partners. J&J, which has the most M&A firepower according to Jefferies analysts, has dished out tens of billions of dollars to bring new medical technology and drug development companies into its fold in recent years. Intra-Cellular gives the healthcare giant an approved neuro medicine and a broad pipeline of experimental therapies being explored for conditions like depression, pain, generalized anxiety disorder, and Alzheimer’s agitation and psychosis, among other indications. Citing a wide-ranging pipeline and a quickly growing commercial franchise, Intra-Cellular’s board told J&J that the initial offer “significantly undervalued” the company. Mates told J&J CEO Joaquin Duato that an offer closer to $140 per share “would be necessary to obtain the support of the board,” according to the filing. J&J eventually upped its initial offer by $17 per share. The final offer of $132 per share — shy of the $140 request — made a splash at the annual JP Morgan Healthcare Conference in January. The announcement breathed new life into the biopharma M&A market, marking the largest buyout since deal-heavy December 2023. That month, Karuna Therapeutics, ImmunoGen and Cerevel Therapeutics announced exits of $14 billion, $10.1 billion and $8.7 billion, respectively. It’s also one of the largest M&A exits for a woman-led biotech. Mates founded the biotech in 2002 and has been CEO ever since. Intra-Cellular’s work is based on research from the late Paul Greengard, a neuroscientist who investigated how different signal substances operate and affect the “inner-working of cells in the body,” per the company’s website. While at Rockefeller University, he shared the 2000 Nobel Prize for Physiology or Medicine with Arvid Carlsson and Eric Kandel. The company raised a $2.9 million Series A in 2002 and secured about $40 million over the next decade, according to Bruce Booth, a partner at Atlas Venture. Booth and Atlas were not investors in Intra-Cellular. It then reverse-merged into shell company Oneida Resources Corp. in 2013 and soon after raised about $180 million. A decade later, Intra-Cellular raised an eye-popping $460 million in 2022 and $575 million in 2024.

并购上市批准细胞疗法

100 项与 Oneida Research Services, Inc. 相关的药物交易

登录后查看更多信息

100 项与 Oneida Research Services, Inc. 相关的转化医学

登录后查看更多信息