Common deficiencies found in generic Finished Pharmaceutical Product (FPP) applications submitted for registration to the South African Health Products Regulatory Authority (SAHPRA)

Background The aim of the study was to investigate the common deficiencies observed in the Finished Pharmaceutical Product (FPP) section of generic product applications submitted to SAHPRA. The study was conducted retrospectively over a 7-year period (2011–2017) for products that were finalised by the Pharmaceutical and Analytical pre-registration Unit. Methods There were 3148 finalised products in 2011–2017, 667 of which were sterile while 2089 were non-sterile. In order to attain a representative sample for the study, statistical sampling was conducted. Sample size was obtained using the statistical tables found in literature and confirmed by a sample size calculation with a 95% confidence level. The selection of the products was according to the therapeutic category using the multi-stage sampling method called stratified-systematic sampling. This resulted in the selection of 325 applications for non-sterile products and 244 applications for sterile products. Subsequently, all the deficiencies were collected and categorised according to Common Technical Document (CTD) subsections of the FPP section (3.2.P). Results A total of 3253 deficiencies were collected from 325 non-sterile applications while 2742 deficiencies were collected from 244 sterile applications. The most common deficiencies in the FPP section for non-sterile products were on the following sections: Specifications (15%), Description and Composition (14%), Description of the Manufacturing Process (13%), Stability Data (7.6%) and the Container Closure System (7.3%). The deficiencies applicable to the sterile products were quantified and the subsection, Validation and/or Evaluation (18%) has the most deficiencies. Comparison of the deficiencies with those reported by other agencies such as the USFDA, EMA, TFDA and WHOPQTm are discussed with similarities outlined. Conclusions The overall top five most common deficiencies observed by SAHPRA were extensively discussed for the generic products. The findings provide an overview on the submissions and regulatory considerations for generic applications in South Africa, which is useful for FPP manufacturers in the compilation of their dossiers and will assist in accelerating the registration process.

Frequency of Genital Tuberculosis in Patients Undergoing Diagnostic Laparoscopy for Infertility

OBJECTIVES: To determine the frequency of genital tuberculosis in patients undergoing diagnostic laparoscopy for infertility. METHODOLOGY: It is a descriptive (cross-sectional) prospective study. The study was performed within the duration of six months i.e., February 12th, 2020 to August 12th, 2020 at the Department of Obstetrics and Gynecology, Khyber Teaching Hospital, Peshawar. A total of 196 patients were observed by using 47.1% proportion of genital tuberculosis in infertility, 95% confidence interval with margin of error 7%, using software of WHO for sample size calculation. Further, sample collection was performed using non-probability (consecutive) sampling techniques. RESULTS: The mean age of the patients in our study was 30 years (SD+3.92). Fifty seven percent of cases were having primary infertility and 43% of patients were having secondary infertility. The incidence of genital tuberculosis undergoing infertility was 45%. CONCLUSION: Our study concludes that the incidence of genital TB in infertility in our setup was 45%.

Prevalence of Headache and Related Factors in Erciyes University Medical Faculty Students

Headache is one of the oldest known symptoms in humans and headache disorders are among the most common diagnoses in neurology clinics. More than 90% of people experience a headache at least once in their lifetime. Medical students may frequently experience headache triggering situations such as insomnia, fatigue, and stress. The purpose of this research; The aim of this study is to examine the frequency of headache in Erciyes University Faculty of Medicine students, the nature of the pain in patients with headache and related factors.Materials-Methods: This descriptive study; It was conducted with medical faculty students studying at Erciyes University. In March 2019, 1602 students were enrolled in the medical faculty and all of them were planned to be included in the study and the sample size calculation was not made, and a total of 1296 people could be reached when the data collection phase was completed. The obtained data were evaluated in computer environment and p <0.05 values were accepted as significant in statistical analysis. Results: 46.5% of the participants in the study were men and 53.5% were women. 6.9% of the participants stated that they had a diagnosed headache disease, 31.7% stated that they had a headache at least once a week. The triggering factors were mostly; insomnia (77.4%), stresssadness (72.4%), fatigue (%70.0), noise (%59.4), study (%44.5). The frequency of headache is significantly higher in women, those with a family history and those living with their families. The mean severity score of those who describe sharp and throbbing pain, which is mostly seen in migraine, is significantly higher than the feeling of tension and heaviness. Conclusion: One-third of the participants stated that they experienced a headache once or more per week. A significant relationship was found between headache and the factors of gender, family history and place of residence. It has been determined that the factors that trigger pain are mostly insomnia, stress-sadness and fatigue. Medical students can be informed about the examination of headache complaints by the physician and the arrangement of necessary treatments, as well as training on sleep hygiene and coping with stress, and social support can be provided.

Angle Recession in Patients with Closed Globe Injury

Purpose: To determine the frequency of angle recession following closed globe injury in patients presenting to the department of ophthalmology of a tertiary care hospital of Pakistan. Study Design: Descriptive observational study. Place and Duration of Study: Study was conducted at Eye-A Unit, Hayatabad Medical Complex, Peshawar from 14th March 2017 to 14th Sept 2017. Methods: One hundred and sixty three patients were selected for this study after applying WHO sample size calculation formula. Patients with history of closed globe injury were recruited through consecutive sampling technique. A detailed history regarding trauma, causative agent, duration of injury and site of impact was taken. Ocular examination including visual acuity and detailed examination of both anterior and posterior segment was carried out using slit lamp biomicroscope. Gonioscopy was performed to check the presence and extent of angle recession. Results: Mean age was 33 ± 8.82 years. Seventy five percent patients were male and 25% female. Type of trauma included; 57 (35%) patients had road traffic accidents, 33 (20%) patients had stone injuries, 37 (23%) patients had sports injuries while 36 (22%) patients had eye trauma due to other types like fall, fight, glass injuries, chemical exposures etc. In 90 (55%) patients, right eye was affected while 73 (45%) patients had trauma in left eye. Duration of trauma was ? 2 days in 124 (76%) patients while mean duration was 1 day with SD ± 1.034. Conclusion: Frequency of angle recession was 28% following closed globe injury. Key Words: Angle recession, closed globe injury, ocular trauma.

MEDICAL VS SURGICAL TREATMENT FOR SYMPTOMATIC ENLARGED INFERIOR TURBINATE: A COMPARATIVE STUDY

Objective: To determine the nasal patency after reducing the size of hypertrophied inferior turbinate with medication and surgery. Study Design: Prospective comparative study. Place and Duration of Study: Department of Ear, Nose, Throat, Head and Neck Surgery, Medical Teaching Institute, Lady Reading Hospital, Peshawar Pakistan, from Jan to Dec 2019. Methodology: This study was conducted at the After-sample size calculation using an online sample size calculator (OpenEpi) and after obtaining informed consent patients were divided into two groups. Patients in group A were put on medicine only and in group B surgery was conducted to reduce the size of hypertrophied inferior turbinate. Data were analyzed using SPSS version 25 and p<0.05 was considered significant. Results: This study comprised of total 86 patients, in the age range 15-55 years with mean ± SD age 33.47 ± 9.57 years. Males were 47 (54.7%) and females were 39 (45.3%) with male to female ratio of 1.2:1. In group A, males were 22 (25.25%), females were 21 (24.41%), while in group B males were 25 (29.1%) and females were 18 (20.3%). There was no statistically significant difference in nasal patency between the two groups before treatment (p=0.59) and after 10 days of treatment (p=0.69). However, at the end of one month, there was a statistically significant difference in nasal patency between the medically treated and surgically treated groups of patients (p=0.023).Conclusion: Surgical treatment is significantly effective than medical treatment alone.

Study Protocol Document forPONE-D-21-18427R2 (Prevalence and Predictors of GMD among PLWH on cART) v1

This is a document that states about sample size calculation, study participant recruitment, interview and medical record data extraction sheet, sample collection, processing and storage until lab analysis. Moreover, it states about how Glucose Metabolism Disorders (GMD) is determined with specific forms of GMDs.

On sample size calculation in testing treatment efficacy in clinical trials

Summary Sample size calculation is an integral part of any clinical trial design, and determining the optimal sample size for a study ensures adequate power to detect statistical significance. It is a critical step in designing a planned research protocol, since using too many participants in a study is expensive, exposing more subjects to the procedure. If a study is underpowered, it will be statistically inconclusive and may cause the whole protocol to fail. Amidst the attempt to maximize power and the underlying effort to minimize the budget, the optimization of both has become a significant issue in the determination of sample size for clinical trials in recent decades. Although it is hard to generalize a single method for sample size calculation, this study is an attempt to offer something that might be a basis for finding a permanent answer to the contradictions of sample size determination, by the use of simulation studies under simple random and cluster sampling schemes, with different sizes of power and type I error. The effective sample size is much higher when the design effect of the sampling method is smaller, particularly less than 1. Sample size increases for cluster sampling when the number of clusters increases.

Effects of Evolocumab Added to Moderate-Intensity Statin Therapy in Chinese Patients With Acute Coronary Syndrome: The EMSIACS Trial Study Protocol

Background: Several studies have demonstrated that using a higher dose of statin can easily induce liver injury and myopathy. Low-density lipoprotein cholesterol (LDL-C) is a well-established modifiable risk factor for cardiovascular disease; however, the large majority of Chinese patients cannot meet the target level of LDL-C recommended by the Chinese expert consensus. Evolocumab has been demonstrated to reduce LDL-C by approximately 60% in many studies. Nevertheless, whether combined evolocumab and moderate-intensity statin is as effective in lowering LDL-C and decreasing incidence of MACE in Chinese patients presenting with the acute phase of acute coronary syndrome (ACS) remains unknown. Therefore, the “Evolocumab added to Moderate-Intensity Statin therapy on LDL-C lowering and cardiovascular adverse events in patients with Acute Coronary Syndrome” (EMSIACS) is conducted.Methods: The EMSIACS is a prospective, randomized, open-label, parallel-group, multicenter study involving analyzing the feasibility and efficacy of evolocumab added to moderate-intensity statin therapy on lowering LDL-C levels in adult Chinese patients hospitalized for acute phase ACS. The sample size calculation is based on the primary outcome, and 500 patients will be planned to recruit. Patients are randomized in evolocumab arm (evolocumab 140mg every 2weeks plus rosuvastatin 10mg/day or atorvastatin 20mg/day) and statin-only arm (rosuvastatin 10mg/day or atorvastatin 20mg/day). The primary outcome is the percentage change in LDL-C in weeks 4 and week 12 after treatment. The secondary outcome is the occurrence of MACE after 12weeks and 1year of treatment.Discussion: If the EMSIACS trial endpoints prove statistically significant, the evolocumab added to moderate-intensity statin therapy will have the potential to effectively lower subjects’ LDL-C levels, especially for the Chinese patients with acute phase ACS. However, if the risk of MACE is not significantly different between the two groups, we may extend follow-up time for secondary outcome when the clinical trial is over.Clinical trial registration: The study is registered to ClinicalTrials.gov (NCT04100434), which retrospectively registered on November 24, 2020.