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The rate and extent of absorption of a drug from its dosage form is referred to as bioavailability. While bioequivalence between two drug products is attained if their extent and rate of absorption do not relatively differ when administered at the same dose. A bioequivalence study comprises of two or more bioavailability studies which are performed by i) Measurement of active drug substance or its metabolites in the biological fluid; ii) Comparative pharmacodynamic studies in humans; iii) Comparative clinical trials; iv) Comparative in-vitro dissolution studies. The rationale of the study is the monitoring of the pharmacokinetic-pharmacodynamic parameters (AUC, Cmax) after administration of the tested drug. This study is not an experimental study but a form of data analysis and reporting of comparative bioavailability studies. The study data obtained is required to be equipped with applications of new drug products as notified in Schedule Y. Cumulatively, it aids in the development of pharmaceutical preparations in the pharmaceutical industry. This review article aims to illustrate the systematic overview of BA/BE study with an emphasis on its experimental aspects like study design, volunteer selection, dosing regimen, sample collection procedures along with a detailed insight on Informed Consent Document, Case Report Form, Trial Master file and the Protocol which collectively form the backbone of the clinical study.

The aim was to compare objective and subjective cure rates between Uphold™ hysteropexy (HP) and vaginal hysterectomy (VH) with uterosacral suspension. A sample size of 49 in each arm would be required to detect a clinical difference of 20% between the groups. Owing to delayed recruitment, this originally planned randomised controlled trial was changed to a patient preference study after randomising initial 6 participants. Women with symptomatic stage ≥2 uterine descent wishing a surgical solution were included. Routine follow-up was scheduled at 6 weeks, 6 months, 12 months, and annually thereafter. Primary outcome was absence of stage ≥2 apical prolapse. Secondary outcomes included a composite cure of no leading edge beyond the hymen, absence of bulge symptoms and no retreatment; patient-reported outcomes were based on quality-of-life questionnaires (PFDI-20, PFIQ-7, PISQ-12, PGI-I, EQ5D and a health score). We recruited 50 patients undergoing VH between 2011 and 2013 and 51 patients undergoing HP between 2011 and 2016. Participants were followed up for a median of 25 months (23–96). Five women from the VH (10%) and 7 from the HP (14%) group were lost to follow-up. Combined anatomical and symptomatic outcomes were available for 41 (82%) VH and 39 (76%) in the HP group. There was no difference in objective apical outcomes; the incidence of stage 2 prolapse was 0% in the VH group and 2% in HP group (p = 0.50). We found no difference in the composite cure rate (78% VH vs 85% HP, 0.45) between the groups. There was no significant difference in surgical complications (p = 0.33), assessed using Clavien–Dindo classification. There was a 2% surgery rate for mesh exposure in the HP group. Uphold™ uterine suspension and VH appear to have similar objective and subjective cure at 25 months, with no significant difference in surgical complications.

Adolescence is a distinctive stage in human development during which many simple and complex medical conditions can present for the first time. Paediatric and adolescent gynaecological conditions need careful multidisciplinary clinical management with a sensitive approach understanding the patients' psychological and physiological circumstances. The objective of this study is to review the tertiary paediatric and adolescent gynaecology service in Leeds, United Kingdom and to present an overview of the various conditions that present to such a clinic. A total of 985 patients were seen over a 16-year period and the increasing number of patients seen over this time establishes the need for such a service to exist. Complex developmental anomalies of the genital tract and disorders of sexual differentiation formed a major portion of the referrals. Presence of a significant number of referrals for simple gynaecological conditions including menstrual irregularities, gynaecological pain, vulvovaginitis, polycystic ovary syndrome and concerns about labial appearance indicates the reluctance of general gynaecologists and general practitioners to manage such conditions in young patients. This emphasizes the need for continued education of primary health care professionals and establishment of clear guidelines and care pathways for the management of this special patient group.

The present study was undertaken at the Port Moresby General Hospital, Papua New Guinea, to evaluate the ease of use and acceptability of a perineal measuring device (Episiometer) for giving a correct length and angle of a mediolateral episiotomy. An Episiometer was placed on the perineum to guide the angle and length immediately before giving an episiotomy. A feedback survey was collected and the angle and length of the episiotomy were measured at the time of delivery and at 6 weeks postpartum. The length and angle of episiotomy were found to be accurate in 86% of the cases. Forty-two of the fifty (86%) clinicians felt that the Episiometer was easy or very easy to use. They also found this device to be beneficial (92%). The Episiometer seems to be an easy-to-use and feasible device that is well accepted by clinicians and patients and may aid in standardising the length and angle of an episiotomy.Impact statement What is already known on this subject? Episiotomy is the commonest obstetric procedure performed worldwide. However, the angle and length of an episiotomy vary greatly amongst operators. It is also recognised that birth trauma and an inaccurate episiotomy result in debilitating anal sphincter injury. Therefore, a pilot study was conducted to evaluate the ease of use and acceptability of a new, inexpensive, low- tech device "Episiometer" to guide clinicians and midwives to perform an appropriate episiotomy. What do the results of this study add? This pilot study to evaluate the usability of the new innovation amongst clinician and patients revealed high acceptance of the device amongst clinicians and positive attitude of the patients towards the device. The clinicians also felt the device to be an effective teaching tool. Usage if the device results in a more accurate length and angle of an episiotomy.

Conventional surgery for female stress incontinence is usually successful but recurrent cases are difficult to treat. This study of 20 such cases treated by the Remeex TRT system shows symptomatic benefit up to 5 years following insertion of the device. The benefit of this procedure is that the sling can be adjusted to the correct tension in the optimum leak position and circumstances, and anytime thereafter without the need to repeat the entire operation. As a result, the voiding dysfunction rate and need to intermittent self-catheterise is reduced, even with a low pressure urethra. The cost per procedure and complication rate is higher that standard TVT, and the device may occasionally need removal due to persistent seroma. However, the improved quality of life makes this operation an attractive option in recurrent cases of female stress incontinence.

There are various indications for screening pregnant women for gestational diabetes. Screening is then often carried out by performing a timed random blood sugar (t-RBS). In this unit a raised t-RBS is an indication to perform a glucose tolerance test (GTT), and if this is abnormal, the patient is managed with dietary modification or insulin therapy. A t-RBS is considered abnormal if the fasting value (2 hours since last meal) is5.7 mmol/l, or the non-fasting value (2 hours since last metal) is6.3 mmol/l. However, higher t-RBS values have been recommended by the Diabetic Pregnancy Study Group. This group considers a t-RBS abnormal if the fasting value is6.1 mmol/l, or the non-fasting value is7.0 mmol/l. A retrospective audit was carried out to determine if cases of gestational diabetes would have been missed if the new guidelines were adopted. There were 112 patients with a fasting t-RBS of 5.8 to 6.1 mmol/l, inclusive, and 196 patients with a non-fasting t-RBS of 6.4 to 7.0 mmol/l, inclusive; 45 patients did not have a GTT result. Therefore 263 patients were included in the study. The number of patients with a normal GTT result was 257 (97.7%), and 6 (2.30%) patients had an abnormal GTT result. Only 4 (1.52%) were labelled as gestational diabetics, and all these cases were managed with diet alone with no adverse obstetric outcome. A large number of GTTs are performed unnecessarily in our unit, and the values recommended by the Diabetic Pregnancy Study Group should be adopted.

Aim. To describe a new technique of uterine manipulation in laparoscopic management of pelvic cancers.Material and Methods. We used a novel uterine hitch technique in 23 patients from May 2008 to October 2008. These patients underwent pelvic oncologic surgery including laparoscopic radical hysterectomy (n=7), laparoscopic anterior resection (n=4), laparoscopic abdominoperineal resection (n=3), laparoscopic posterior exenteration (n=4), or laparoscopic anterior exenteration (n=5). The uterus was hitched to the anterior abdominal.wall by either a single suture in the fundus or by sutures through the round ligaments.Results. The uterine hitch technique was successfully accomplished in all procedures. It was performed in less than 5 minutes in all cases. It obviated the need for vaginal manipulation. An extra port for retraction could be avoided. There were no intraoperative complications.Conclusion. A practical, cheap and reproducible method for uterine manipulation, during pelvic oncologic surgery is described. It improves the stability of the uterus and also obviates the need for keeping an additional assistant for vaginal manipulation in any of the procedures.