STABILITY STUDY: REGULATORY REQUIRENMENT

Stability is an essential factor of quality, safety and efficacy of a drug product. The objective of stability study is to determine the shelf life, the time period of storage at a specified condition within which the drug product still meets its established specifications. Stability study is of three types that is physical, chemical and microbial stability. Various factors like oxygen, water, temperature, pH, moisture, light and concentration affect the stability. Present work aims to represent the stability testing (ST) requirements of International Conference on Harmonization (ICH), different regulatory agencies like, World Health Organization (WHO), Association of South East Asian Nations (ASEAN) and European Agency for Evaluation of Medicinal and Health Products (EMEA) and difference of those agencies with respect to ICH guideline. Most of the stability requirements for WHO, ASEAN, and EMEA are similar to the ICH guideline, except for the parameters like selection of batches and storage conditions

STABILITY STUDY: REGULATORY REQUIREMENT

Stability is an essential factor of quality, safety and efficacy of a drug product. The objective of stability study is to determine the shelf life, the time period of storage at a specified condition within which the drug product still meets its established specifications. Stability study is of three types that is physical, chemical and microbial stability. Various factors like oxygen, water, temperature, pH, moisture, light and concentration affect the stability. Present work aims to represent the stability testing (ST) requirements of International Conference on Harmonization (ICH), different regulatory agencies like, World Health Organization (WHO), Association of South East Asian Nations (ASEAN) and European Agency for Evaluation of Medicinal and Health Products (EMEA) and difference of those agencies with respect to ICH guideline. Most of the stability requirements for WHO, ASEAN, and EMEA are similar to the ICH guideline, except for the parameters like selection of batches and storage conditions

Anomalistic Disturbance Torques during the Entry Phase of the Mars Exploration Rover Missions: A Telemetry and Mars-Surface Investigation

Shortly after landing on Mars, post-flight analysis of the "Spirit" entry data suggested that the vehicle experienced large, anomalistic oscillations in angle-of-attack starting at about M=6. Similar analysis for "Opportunity " found even larger oscillations starting immediately after maximum dynamic pressure at M=14. Where angles-of-attack of 1-2 degrees were expected from maximum dynamic pressure to drogue deployment, the reconstructions suggested 4 to 9 degrees. The next Mars lander, 2007 Phoenix project, was concerned enough to recommend further exploration of the anomalies. Detailed analysis of "Opportunity" data found significant anomalies in the hypersonic aerodynamic torques. The analysis showed that these torques were essentially fixed in the spinning vehicle. Nearly a year after landing, the "Oportunity" rover took pictures of its aeroshell on the surface, which showed that portions of the aeroshell thermal blanket assembly still remained. This blanket assembly was supposed to burn off very early in the entry. An analysis of the aeroshell photographs led to an estimate of the aerodynamic torques that the remnants could have produced. A comparison of two estimates of the aerodynamic torque perturbations (one extracted from telemetry data and the other from Mars surface photographs) showed exceptional agreement. Trajectory simulations using a simple data derived torque perturbation model provided rigid body motions similar to that observed during the "Opportunity" entry. Therefore, the case of the anomalistic attitude behavior for the "Opportunity" EDL is now considered closed and a suggestion is put forth that a similar event occurred for the "Spirit" entry as well

Relationship between the amniotic fluid index at term and the perinatal outcome

Background: Amniotic fluid index (AFI) is commonly used to estimate amniotic fluid volume. A proper AFI is between 10 and 24 centimetres. If it is below 5 cm, it is can represent oligohydramnios, and in case AFI is above 24 cm, it can represent polyhydramnios. This study was undertaken to determine whether measuring AFI at term is useful in the prediction of perinatal outcome.Methods: A prospective study of 250 pregnant women with gestational age between 37 and 42 weeks was conducted at Sola Civil Hospital. AFI was measured in each patient using the Phelan’s technique and the perinatal outcome was studied. The results were analysed and presented in the form of tables and graphs.Results: Total 250 patients were studied. Out of them, 33 patients (13.2%) had AFI =25.19 out of 33 (57.57%) patients with AFI <= 5, had to undergo caesarean section, out of which, 12 caesarean sections (63.15%) were taken for non-reassuring foetal status. 36.27% (78/215) of patients with AFI between 6 and 24 underwent caesarean section, out of which 38.46% (30/78) underwent caesarean section for non-reassuring foetal status.Conclusions: In the presence of oligohydramnios, the rates of LSCS due to foetal distress, the occurrence of low Apgar score and of low birth weight are higher than in patients with normal liquor at term. Thus, measuring the amniotic fluid index at term can be helpful in the prediction of perinatal outcome

New limits on top squark NLSP from ATLAS 4.7 fb−1fb^{-1} data

Using the ATLAS 4.7 $fb^{-1}$ data on new physics search in the jets + \met channel, we obtain new limits on the lighter top squark ($\tilde t_1$) considering all its decay modes assuming that it is the next to lightest supersymmetric particle (NLSP). If the decay \lstop \ra c \lspone dominates and the production of dark matter relic density is due to NLSP - LSP co-annihilation then the lower limit on \mlstop is 240 GeV. The limit changes to 200 GeV if the decay \lstop \ra b W \lspone dominates. Combining these results it follows that \lstop NLSP induced baryogenesis is now constrained more tightly.Comment: 9 pages, 2 figures, published in MPL

Analysis of Mullerian developmental defects in a tertiary care hospital: a four year experience

Background: Mullerian duct anomalies are congenital anomalies of the female genital tract. Mullerian duct anomalies affect the reproductive health of the female to a varied extent. This may present as obstructive or as non-obstructive anomalies. When clinically suspected, proper investigations are required to confirm the diagnosis including ultrasonography, laparoscopy and hysteroscopy.Methods: In the present study, all the patients presenting with Mullerian duct anomalies to the gynaecology OPD at General Hospital, Sola, GMERS Medical College, Ahmedabad during the four year duration from 2011 to 2014 were included. These patients were analysed with respect to their incidence, presenting complain, age at presentation, classified according to AFS classification after proper diagnosis and managed individually.Results: The incidence of Mullerian duct anomalies was found to be 0.084%.52.9% belonged to the age group of 21 to 25 years. Most of these patients (73.5%) presented with chronic complains. Only a few presented with acute symptoms (14.7%) whereas a few were asymptomatic (11.8%). Septate uterus (20.6%) was the most common anomaly diagnosed at our setup followed by bicornuate uterus (17.7%) and tansverse vaginal septum (17.6%). History along with clinical and USG examination were adequate in diagnosis of patients with vaginal agenesis, didelphic, bicornuate uterus, TVS and imperforate hymen. Laparoscopy was needed to confirm cases of MRKH & unicornuate uterus and hysteroscopy for cases of septate uterus. Arcuate uterus was diagnosed during LSCS. Conclusions: It was thus concluded that with timely evaluation, diagnosis and optimal management, their menstrual disturbances are relieved early in adolescence period recuperating their psychiatric health & improving their reproductive carrier. Delay in management may cause serious complications and potential infertility

Research in the assessment of capture and culture fisheries along the Indian coast

A review of the research conducted at National Institute of Oceanography, Goa to assess the capture and culture fishery potential of India is presented in the paper- the primary, secondary and benthic productivity of estuaries and backwaters are elucidated by taking the Mandovi-Zuari estuarine system as an example. The productivity of the coastal and oceanic waters around India are discussed. The expected fishery yield and present level of exploitation are assessed and further course of action discussed in this paper, in culture fisheries the contributions of NIO in the fields of mussel culture, shrimp culture, brine shrimp culture, seaweed culture, horse-shoe crab culture and fish culture are reviewed and discussed

Pyometra in the postpartum: a forgotten complication

We report a case of 37 years old women who conceived after in vitro fertilization (IVF). Her antenatal course was uneventful. On delivery there was placenta acreta. She later presented in the postpartum period with pyometra. She was managed with conservative treatment. We believe that the placental bed sutures and the sloughing placenta could have led to sterile pyometra in this patient. This rare but important complication need to be kept in mind specially in high risk women with thin endometrium, h/o IVF, cervical encerclage, and placenta acreta

Failure to obtain positive MEM tests in either cell-mediated immune conditions in the guinea-pig or in human cancer.

The macrophage electrophoretic mobility test described by Caspary and Field (1971) and modified by Pritchard et al. (1973) was investigated in various models of cell-mediated immune conditions in the guinea-pig and in cancer in man. No positive results were obtained in 92 guinea-pig experiments. Only 17 of 154 experiments on 74 patients gave definite positives in experiments with human cancer and a few positive results were obtained with normal healthy subjects