15^th International Conference on Clinical and Experimental Dermatology September 28-29, 2018 San Antonio, Texas, USA

Biography:

Bindu has completed her Bachelors in Pharmacy at the age of 21 years from Acharya Nagarjuna University, India and M.S. in Chemistry (Thesis) from Western Illinois University, US. She started her career as an Associate Scientist and worked on a variety of dosage forms including oral solutions, transdermal patches, topical dosage forms and parenteral dosage forms. She worked in generic dermatology industry over 8 years and has more than 18 ANDA approvals in US within short span and 8 more products are currently under filing with the agency. She has 2 publications in reputed journals and also completed her Regulatory Affairs Certification (RAC).

Abstract:

Topical drug delivery is considered one of the safest and easiest drug delivery approaches for many reasons. Topical formulations are designed to deliver drugs to the skin to treat skin disease conditions or to alleviate symptoms. Developing a dermatology generic drug product involves many regulations and needs critical understanding of the test product as well as reference product in order to make the test formulation structurally and functionally similar to the reference product. Current regulations require conducting clinical end point trials for demonstrating bioequivalence (BE) between topical generic and refernce listed drug (RLD) products. A variety of surrogate methods have been explored but with limited success. FDA has been continuously coming up with new regulatory standards to make high quality and affordable medicines available to public and the generic industry is trying to adapt to the new requirements. Bioequivalence sudies on topical products still remained one of the challenging topics in the generic industry because of two reasons: i) due to high complexity of topical dosage forms ii) due to lack of proper design of BE studies. The new GDUFA II guidance gives a clear pathway to assist generic pharmaceutical industry with identifying the most relevant methodologies for developing drugs and generating evidence needed to support ANDA approval. To develop a therapeutically equivalent drug product to a specific reference product, it is necessary to identify the key scientific principles for consistent and efficient identification of BE methods. Availability of product quality matrices i.e. Q1 (qualitatively the same), Q2 (quantitatively the same) and Q3 (microstructure/ physical attributes of the topical dosage form) is critical to demonstrate that generic topical product is therapeutically equivalent.

Biography:

Dr Prachi Chetankumar Gajjar is a third year resident doctor in Department of Dermatology. She has a keen interest in dermoscopy as well as pediatric dermatology. She has acquired training in research methology organized by Indian council of medical research held at Chennai. Following which she has contributed as an author in few publications in national and international journals. She has also delivered talk on “Clinical trial registry of India” in post graduate orientation programme held in Government medical college, Bhavnagar and on “Mucocutaneous manifestations of connective tissue disease” in Rhematology CME at the same venue. She has also presented E posters and oral presentation in state and national conferences in India.

Abstract:

Biography:

Abstract:

Introduction: Low-dose thalidomide is an effective treatment option for chronic cutaneous lupus erythematosus(CCLE) in resistant cases.Rarely, it can cause thrombocytopenia.

Clinical Summary: A 39 year old female presented to Dermatology OPD with CCLE.She had history of repeated episodes for 21years. On examination,unsightly lesions with scarring were present over face and scalp.She was given topical and oral Corticosteroids ,hydroxychloroquine etc.Thalidomide was then considered as disease was not responding to conventional therapy.

She was initially given Thalidomide 100mgBD for 2 weeks to which she responded well.It was later omitted by patient.One month later, she presented with exacerbation of LE and Thalidomide was restarted. However, after single dose of Thalidomide, she developed complaints of gradually progressing purpuric lesions over scalp and face.She also had complaint of menorrhagia. She was not on any other medications.On examination ,multiple purpuric lesions were present over preexisting CCLE plaques over forehead, malar area of face and scalp.Tablet Thalidomide was omitted.Investigation showed thrombocytopenia with platelet count of 4000/cumm and deranged coagulation profile with increased prothrombin time and decreased aPTT. The patient was hospitalized and  administered 1 unit Packed Cell Volume of blood.She was followed up with daily haemogram.

An increasing trend in platelet count after cessation of Thalidomide, in absence of any other cause, was suggestive of Thalidomide induced thrombocytopenia,a rare,yet reported adverse effect.

Discussion: Thalidomide induced thrombocytopenia and neutropenia has been reported in cases of multiple myeloma.However,its occurrence in CCLE has not been observed.

Conclusion: Awareness about rare but fatal ADRs can save the life of patient.

Biography:

Dr. Somil Singhal has completed his Bachelor Of Medicine and Surgery ( MBBS) at the age of 25 years of age from Beijing Medical University, China and Post Doctoral Studies in Doctor Of Medicine In Pathology from Ragiv Gandhi University Of Health Sciences, Bangalore, India. Currently he is working as Pathologist in the Haematology Departrment at Maharaja Agresen Group Of Hospitals , NewDelhi, India. He has attended various Conferences, CME’s and published Case studies , Dessertation in reputed journals like IJLSSR, Index Copernicus, Poland Journal Of Dermatology and is the life member of Indian Medical Association and Allahabad Medical Association. Besides this he had worked as a resident in AIIMS Trauma Center in the department of emergency medicine, Cardiac resident at Fortis Hospital Okhla, Delhi and attended various ITO and blood bank camps for service to hthe society.

Abstract:

The World Health Organization (WHO) defines anemia as a hemoglobin <13 g/dl (hematocrit <39%) for adult males and <12 g/dl (hematocrit <36%) for adult non-pregnant females  The most commonly encountered disorders with hypochromic anemia are iron deficiency anemia and beta thalassemia trait. Other disorders to consider includes anemia of chronic disease, lead toxicity and sideroblastic anemia Iron deficiency anaemia is the most common microcytic hypochromic anemia worldwide resulting from lack of sufficient iron to synthesize hemoglobin  Iron deficiency anemia in adults is caused by loss of blood, while in childhood faulty diet is to blame. It is a severe stage of iron shortage in which hemoglobin (or haematocrit) falls below normal range .  Affected individuals show RBC morphological change of microcytosis, hypochromia, anisocytosis and poikilocytosis Beta thalassemia trait (BTT) is an important differential diagnosis of iron deficiency anemia Thalassemia is one of the main autosomal recessive hereditary hemoglobinopathies established within the world population mainly in Mediterranean belt, Far eastern and South East Asian international locations.

Thalassemias are a collection of hemoglobinopathy due to genetic mutations of the hemoglobin (Hb) genes, ensuing in reduced production or total absence of 1 or more globin chains.

Thalassemia includes two main classes, alpha thalassemia and beta thalassemia by the way of their clinical manifestations and genetic background.  Beta thalassemia is the most frequent type of thalassemia which may be categorised in addition into 3 forms: β thalassemia major , β thalassemia intermediate and β thalassemia minor / β thalassemia trait. In developing countries like india where resources are limited, thalassemia is a major health burden. Earlier studies have shown that the overall prevalence of β-thalassemia is 3–4 % with an estimate of around 8,000 to 10,000 new births with major disease each year.  Affected individuals show increased RBC count with morphological change of microcytic hypochromic with no polychromasia and presence of target cells . In the Indian population where the incidence of the beta thalassemia gene is 3-15% depending on the region, it is important to detect the thalassemia carrier and offer genetic counseling and screening of the spouse to prevent the birth of children with beta thalassemia major ^.Anemia of chronic disorders is a type of anemia associated with a variety of chronic inflammatory, infectious or neoplastic disorders. There is decreased red cells survival, inadequate marrow response, impaired iron mobilization and iron uptake by erythroid cells . The affected individual show RBC morphological change of normocytic normochromic or microcytic hypochromic red cells and the reticulocyte count is decreased. The Sideroblastic Anemia is a refractory anemia with microcytic hypochromic red cells due to a defect in heme synthesis and the inability of mitochondria of developing red cells to incorporate iron into the heme molecule. There is a defect in heme synthesis and the iron transported to the mitochondria gets accumulated. The affected individual shows high degree of anemia with RBC morphological change of marked anisocytosis and poikilocytosis with appearance of microcytes, normocytic normochromic and target cells.Therefore, anemia is adults is a complex problem owing to variations in various haemaological parameters. A complete physical examination should be done in case of anemia as failure to respond to iron therapy means that the person has another cause of anemia. Hence, this neccessity need to take up the study on haematological profile of hypochromic anemia.