Ich M7

Teasdale, Andrew

doi:10.1002/9781118971147.ch24

Cited by 30 publications

(6 citation statements)

References 35 publications

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“…Any other impurity listed in other international pharmacopeias should also be controlled in the API specifications unless otherwise, scientific justification should be provided. Limits for impurities for non-compendial APIs should be in line with the relevant ICH guidelines [ 16 – 19 ].…”

Section: Discussionmentioning

confidence: 99%

A Retrospective Analysis of Applications for Registration of Generic Medicines Processed by the Medicines Control Authority of Zimbabwe

Samunda

Sithole

Khoza

2022

Ther Innov Regul Sci

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Background Many applications for registration of medicines are rejected because applicants fail to submit or resolve critical deficiencies in the quality, efficacy, and safety of the medicines. The study aimed to establish approval rates, processing timelines, and common deficiencies of generic medicines applications processed by the Medicines Authority of Zimbabwe (MCAZ). Method A retrospective study of applications finalized by MCAZ between 2018 and 2020 was conducted. Data were collected from the assessment reports and verified with copies of letters sent to the applicants. Deficiencies were classified as administrative, quality, efficacy, and safety. Other characteristics collated included time to finalization, dosage form, region of origin, and therapeutic class. Results Of the 579 finalized applications, 74.1% were approved while 25.9% were refused. Approved applications had more review cycles (median = 3 cycles) compared to refused applications (median = 2 cycles). However, refused applications had longer review times (median = 25 months) compared to approved applications (median = 18 months). The majority of applications (83.0%) were from Asian manufacturers and intended for oral administration (66.1%). Medicines for the endocrine system (50.0%) and rheumatism/gout (53.3%) had lower approval rates compared to other therapeutical classes (p < 0.001). The most common reasons for refusal of applications included failure to respond to review queries (52.6%), deficiencies in the API information (54.7%), FPP specifications (42.7%), FPP stability data (36.0%), and pharmaceutical development (31.3%). Conclusion To improve the quality of applications and evaluation outcomes, there may be a need for the regulatory authority to engage applicants through training and pre-submission meetings.

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Section: Discussionmentioning

confidence: 99%

A Retrospective Analysis of Applications for Registration of Generic Medicines Processed by the Medicines Control Authority of Zimbabwe

Samunda

Sithole

Khoza

2022

Ther Innov Regul Sci

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“…FDA recommendations put the emphasis on design and analysis of shedding studies for virus or bacteria‐based gene therapy and oncolytic products (FDA, 2015). For genetically modified oncolytic viruses, ICH Q5B Quality guidelines (Teasdale, 2018) can be useful with regard to evaluating gene stability.…”

Section: Discussionmentioning

confidence: 99%

Oncolytic virus preclinical toxicology studies

Rasa¹,

Alberts²

2022

J of Applied Toxicology

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With the ever‐emerging concerns of patient safety during medical care, the search for treatments as safe as possible is a priority, especially when focusing on cancer treatment of which therapies often go hand in hand with severe side effects. Oncolytic virotherapy is an emerging treatment for cancer that is promising in both safety and efficacy. Many currently ongoing clinical trials demonstrate the growing interest in this field. To conduct clinical trials, preclinical studies are mandatory; however, there are not many reviews of toxicology studies on oncolytic virus therapies. This article summarizes the preclinical toxicology studies of the most well studied oncolytic viruses, including Oncorine, Talimogene laherparepvec, Cavatak, ONYX‐015, teserpaturev and Rigvir, a non‐pathogenic ECHO‐7 virus. It is concluded that oncolytic viruses have been shown to have low toxicity and high tolerability in preclinical toxicology studies.

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“…The optimized HPLC method was validated according to ICH Quality Guidelines Q2(R1) Validation of Analytical Procedures (2018) with parameters including specificity, stability, accuracy, precision, linearity, range, the limit of detection (LOD), the limit of quantification (LOQ), and robustness [33].…”

Section: Rp-hplc Methods Validationmentioning

confidence: 99%

RP-HPLC-Based Flavonoid Profiling Accompanied with Multivariate Analysis: An Efficient Approach for Quality Assessment of Houttuynia cordata Thunb Leaves and Their Commercial Products

Nguyen,

Ha,

et al. 2023

Molecules

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Chemical profiling for quality monitoring and evaluation of medicinal plants is gaining attention. This study aims to develop an HPLC method followed by multivariate analysis to obtain HPLC profiles of five specific flavonoids, including rutin (1), hyperin (2), isoquercitrin (3), quercitrin (4), and quercetin (5) from Houttuynia cordata leaves and powder products and assess the quality of H. cordata samples. Eventually, we successfully established HPLC-based flavonoid profiles and quantified the contents of 32 H. cordata fresh leave samples and four powder products. The study also quantified the contents of those five essential flavonoids using an optimized RP-HPLC method. Peak areas of samples were then investigated with principal component analysis (PCA) and hierarchical cluster analysis (HCA) to evaluate the similarity and variance. Principal components in PCA strongly influenced by hyperin and quercetin showed that the samples were clustered into subgroups, demonstrating H. cordata samples’ quality. The results of HCA showed the similarity and divided the samples into seven subgroups. In conclusion, we have successfully developed a practical methodology that combined the HPLC-based flavonoid profiling and multivariate analysis for the quantification and quality control of H. cordata samples from fresh leaves and powder products. For further studies, we will consider various environmental factors, including climate and soil factors, to investigate their effects on the flavonoid contents of H. cordata.

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Ich M7

Cited by 30 publications

References 35 publications

A Retrospective Analysis of Applications for Registration of Generic Medicines Processed by the Medicines Control Authority of Zimbabwe

A Retrospective Analysis of Applications for Registration of Generic Medicines Processed by the Medicines Control Authority of Zimbabwe

Oncolytic virus preclinical toxicology studies

RP-HPLC-Based Flavonoid Profiling Accompanied with Multivariate Analysis: An Efficient Approach for Quality Assessment of Houttuynia cordata Thunb Leaves and Their Commercial Products

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