Chinese Journal of New Drugs 

About: Chinese Journal of New Drugs is an academic journal. The journal publishes majorly in the area(s): Pharmacokinetics & High-performance liquid chromatography. It has an ISSN identifier of 1003-3734. Over the lifetime, 870 publications have been published receiving 1912 citations.

Guideline on missing data in confirmatory clinical trials

Abstract: Missing data is an unavoidable problem in the research of confirmatory clinical trials,and the approach for handling missing data is an important factor affecting the objectivity of the trial conclusions.The data missing in the clinical trial is mainly induced by drop-out,which could be classified as missing completely at random(MCAR),missing at random(MAR) and missing not at random(MNAR) according to the mechanism.The bias of trial conclusion could be reduced through the complete case analysis,careful selection of the method handling for missing data(e.g.,imputation and mixed models) and the sensitivity analysis.To address this issue,European Medicines Evaluation Agency(EMEA) published a guideline on the missing data in the confirmatory clinical trial,and now it had come into effect.With focus on this guideline,we presented the main methods for handling missing data in clinical trials in this paper with the aim providing information for the drug development and clinical research in China.

Efficacy and safety of pregabalin in patients with diabetic peripheral neuropathy or postherpetic neuralgia:Open-label, non-comparative,flexible-dose study

Abstract: We assessed the efficacy and safety of a flexible‐dose pregabalin regimen in patients with diabetic peripheral neuropathy (DPN) or postherpetic neuralgia (PHN) under clinical practice conditions. Further, the trial investigated the correlation of unspecific measures of change (patient and physician global impression of change, PGIC and CGIC) and specific measures of morbidity.

Emergency use authorization of medical products

Abstract: The Emergency Use Authorization(EUA) is an authorization by the Food and Drug Administration(FDA) for the use of medical products,i.e.,an unapproved product or for the unapproved use of an approved product,when an emergency or a potential emergency exists.The background and legal bases for the EUA,the role of the EUA as a mission of the FDA,the procedures of the review,issuing,termination of the EUA are studied,and the successful experiences in responding to the 2009 H1N1 influenza pandemic and the challenges are analyzed.The emergency authorization of ArepanrixTM A/H1N1 vaccine and Novartis H1N1 vaccine in Japan in 2009 is also analyzed comparatively.

Ceftaroline:a new cephalosporin with activity against resistant Gram-positive pathogens

Abstract: Ceftaroline fosamil is a novel,parenteral,broad-spectrum cephalosporin exhibiting bactericidal activity against Gram-positive organisms,including MRSA and multidrug-resistant Streptococcus pneumoniae(MDRSP),as well as common Gram-negative pathogensOn Oct29,2010,the USFood and Drug Administration approved ceftaroline fosamil to treat adults with community acquired bacterial pneumonia(CABP) and acute bacterial skin and skin structure infections(ABSSSI),including methicillin-resistant Staphylococcus aureus(MRSA)The chemistry and structure-activity relationship,antibacterial activity,pharmacokinetics,pharmacodynamics,therapeutic efficacy,adverse effects were reviewed in this paper

Glycan changes:cancer metastasis and anti-cancer vaccines

Abstract: Changes in glycosylation are often hallmark in malignant tumors.Those changes hap- pened on the whole cells or some specific molecules.The review focuses on the recent recognitions in the correlationship between glycosylation and the metastasis potential of tumor cells.Utilizing these glycosyla- tions in development of anti-adhesion approach to prevent tumor metastasis,development of anti-cancer vaccine is one of promising targets of future study.