STABILITY TESTING GUIDELINES OF PHARMACEUTICAL PRODUCTS

Stability studies of pharmaceutical products ensuring the maintenance of product quality, safety and efficacy throughout the shelf life are considered as pre-requisite for the acceptance and approval of any pharmaceutical product. Stability of a pharmaceutical product may be defined as the capability of a particular formulation in a specific container/closure system to remain within its physical, chemical, microbiological, toxicological, protective and informational specifications. Stability studies are required to be conducted in a planned way following the guidelines issued by ICH, who and or other agencies. Importance of various methods followed for stability testing of pharmaceutical products, guidelines issued for stability testing and other aspects related to stability of pharmaceutical products have been included in the present review Keywords: stability testing, stability studies, stability, pharmaceutical products, international council for harmonisationÂ

Treatment decision for recurrences in non-small cell lung cancer during or after adjuvant osimertinib: an international Delphi consensus report

IntroductionOsimertinib is recommended by major guidelines for use in the adjuvant setting in patients with EGFR mutation-positive NSCLC following the significant improvement in disease-free survival observed in the Phase III ADAURA trials. Due to limited real-world data in the adjuvant setting, little guidance exists on how to approach potential recurrences either during or after the completion of the treatment. This study aimed to reach a broad consensus on key treatment decision criteria in the events of recurrence.MethodsTo reach a broad consensus, a modified Delphi panel study was conducted consisting of two rounds of surveys, followed by two consensus meetings and a final offline review of key statements. An international panel of experts in the field of NSCLC (n=12) was used to provide clinical insights regarding patient management at various stages of NSCLC disease including patient monitoring, diagnostics, and treatment approach for specific recurrence scenarios. This study tested recurrences occurring 1) within or outside the central nervous system (CNS), 2) during or after the adjuvant-osimertinib regimen in NSCLC disease which is 3) amenable or not amenable to local consolidative therapy.ResultsPanellists agreed on various aspects of patient monitoring and diagnostics including the use of standard techniques (e.g., CT, MRI) and tumour biomarker assessment using tissue and liquid biopsies. Consensus was reached on 6 statements describing treatment considerations for the specific NSCLC recurrence scenarios. Panellists agreed on the value of osimertinib as a monotherapy or as part of the overall treatment strategy within the probed recurrence scenarios and acknowledged that more clinical evidence is required before precise recommendations for specific patient populations can be made.DiscussionThis study provides a qualitative expert opinion framework for clinicians to consider within their treatment decision-making when faced with recurrence during or after adjuvant-osimertinib treatment

Recrafing Indian Industry: A Note

After independence in 1947, India embarked on an ambitious path of industrialisation, following the standard modern developmental prescription drawn from the experience of the so-called developed countries. Since the inauguration of the reform era in 1991, this model of development, duly globalised, has been reinforced by the decisions made by metropolitan policy elites both within and beyond India

Property rights, deforestation, and community forest management in the Himalayas: An analysis of forest policy in British Kumaun, 1815-1949

Under what conditions can one expect to see a sustained system of community management of forests in operation? Considerable theoretical scepticism has been expressed by economists and others about the viability of any such institution. In this view, such institutions will inevitably result in a tragedy of the commons. However, evidence from around the world has accumulated in recent years which suggests that common property institutions do exist, and in some cases, have existed for a long time. Using archival sources in India and the U.K., this thesis explores the fate of community management of forests in a region of the central Himalayas known as Kumaun. Kumaun was under British administration over the period 1815-1949. The forests of the region were not under formal state management till the 1860s. In fact, there is evidence of customary cooperative arrangements--informal local institutions--before the arbitrary takeover of forests by the new administrators. The new property regime had a disruptive effect on local institutions and precipitated much deforestation, especially since the state did not have the logistical wherewithal to enforce the new forest rules at a time when local arrangements had lost credibility. Two schools of thought emerged within the state bureaucracy to address the emerging crisis of rapidly diminishing forests. The centralizers argued for more effective supervision and an increase in state power in order to protect the forests. The devolutionists, by contrast, canvassed for decentralized management by user communities. Several decades of experimentation with centralized methods failed to protect forests effectively and caused much political protest. The government ultimately had to resurrect local institutions in the 1920s. In the beginning this was a failure, since community management had lost all credibility in the eyes of local users. However, persistent efforts by government officers finally paid off and the new system of van panchayats (village forest councils) finally solved a problem which the state, on its own, could not

Economists on the wrong foot

Abstract: The operations of the mainstream growth economy are actually taking something away from the survival and subsistence economies of the poor

Impact of Moderate Sedation versus Monitored Anesthesia Care on Outcomes and Cost of Endobronchial Ultrasound Transbronchial Needle Aspiration

Background and Objectives. The ideal type of sedation for endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) is not known. Two previous studies comparing the diagnostic yield between moderate sedation (MS) and deep sedation/general anesthesia (DS/GA) had provided conflicting results with one study clearly favoring the latter. No study had addressed cost. This is concerning for pulmonologists without routine access to anesthesia services. Our objective was to assess the impact of MS and Monitored Anesthesia Care (sedation administered and monitored by an anesthesiologist) on the outcomes and cost of EBUS-TBNA. Materials and Methods. We performed a retrospective review of prospectively collected data on consecutive EBUS-TBNA performed under two different types of sedation in a single academic center. A diagnostic TBNA was defined as an aspirate yielding any specific diagnosis or if subsequent surgery or follow-up of nondiagnostic/normal aspirates showed no pathology. Current Medicare time-based allowances were used for professional charges calculation. Results. There was no difference observed between MS and MAC in regards of the diagnostic yield (92.9% versus 91.9%), procedure duration, number, location, and size of lymph node (LN) sampled, but there were more passes per LN with MAC. The average charges were 74.30 USD for MS and 319.91 for MAC. There were more hypotensive and desaturations episodes with MAC but none required escalation of care. Conclusions. When performed under MS, EBUS-TBNA has similar diagnostic yield as under MAC but may be associated with less side effects. The difference in sedation cost is modest; however, an additional 245$ for each EBUS done under MAC would have significant cost implications on the health system. These findings are of critical importance for bronchoscopists without routine access to anesthesia services and for optimization of healthcare cost and resource utilization

Antibody-Negative Relapse of Goodpasture Syndrome with Pulmonary Hemorrhage

Goodpasture syndrome is a rare autoimmune disease comprising antiglomerular basement membrane (anti-GBM) crescentic glomerulonephritis and pulmonary capillaritis with circulating anti-GBM antibodies. Rarely, antibody-negative cases have been described. We report a young, African American adult woman admitted with flank pain and hematuria with laboratory testing and kidney biopsy demonstrating anti-GBM crescentic glomerulonephritis with elevated anti-GBM antibody levels. She received treatment but remained dialysis-dependent. She was seronegative and clinically stable until she presented 8 months later with dyspnea and hemoptysis requiring mechanical ventilation. Bronchoscopy revealed diffuse alveolar hemorrhage. She was treated for relapse of Goodpasture syndrome. However, anti-GBM antibodies were undetectable. This case emphasizes prompt diagnosis and treatment of Goodpasture syndrome to preserve renal function. Additionally, clinical manifestations of Goodpasture syndrome and its degree of activity do not necessarily correlate with the actual antibody titer on relapse. Clinicians should have enhanced awareness of this atypical presentation of a rare disease