energetics as per pci syllabus ip-ii industrial pharmacy-ii pattern of inheritance genetic protein synthesis genes and dna chromosomes introduction to genetics: pregnancy and parturition oogenesis spermatogenesis fertilization physiology of menstruation sex hormones functions male and female reproductive s thymus and their disorders. pineal gland pancreas adrenal gland parathyroid gland thyroid gland pituitary gland mechanism of hormone action classification of hormones endocrine system disorders of kidney. role of ras in kidney role of kidneys in acid base b micturition reflex physiology of urine formation anatomy of kidney and nephrons anatomy of urinary tract urinary system resuscitation methods. artificial respiration lung volume regulation of respiration mechanism of respiration anatomy of respiratory system respiratory system human anatomy and physiology b. pharm. sem-ii bmr creatinine phosphate atp energetics formation and role nutrients and disorders of git movements of git pancreas and liver salivary glands large intestine stomach small intestine as per pci syllabus. sem:-ii. b. pharm. first year bp 201t. hap-ii unit-ii: digestive system classification and properties neuroglia neuron organization of nervous b. pharm.-sem:- ii hap-ii nervous system nose and tongue and their disorders. ear special senses structure and functions of eye lymph circulation and functions of lymphatic syste lymphatic vessels lymphatic system lymphatic organs and tissues reticulo endothelial system. its significance and disorders of blood transfusion rh factors blood grouping mechanisms of coagulation anemia formation of hemoglobin hemopoeisis composition and functions of blood body fluids and blood  body fluids types of joints movements and its articulation structural and functional classification neuromuscular junction physiology of muscle contraction salient features and functions of bones of axial a types of bone skeletal system divisions of skeletal system muscular and nervous and connective tissues. location and functions of epithelial structure tissue level of organization classification of tis chapter-1-integumentary system. as per pci syllabu unit ii integumentary system structure and functions of sk forms of intracellular signaling: a) contact-depen intracellular signaling pathway activation by extr cell junctions. general principles of cell communi cell division transport across cell membrane cellular level of organization structure and funct chapter-2 cellular level of organization. unit i sem-i b. pharm. i basic anatomical terminology. homeostasis basic life processes levels of structural organization and body systems introduction to human body definition and scope of bp101t. human anatomy and physiology-i as per b. pharm. sem-i syllabus tbse / sidbi bcil tifac nrdc tt agencies in india - apctd commercialization - practical aspects and problems approved regulatory bodies and agencies analytical method transfer quality control qualification and validation premises and equipments packaging materials) documentation finished products excipients granularity of tt process (api packaging and cleaning) transfer from r & d to production (process quality risk management technology transfer protocol technology development and transfer: who guideline purple book code of federal regulatory federal register orange book laws and acts regulations guidelines guidance regulatory concepts basic terminology pharmacovigilance - safetymonitoring in clinical t managing and monitoring clinical trials sponsors & monitors gcp obligations of investigators informed consent process and procedures institutional review board / independent ethics co clinical trials developing clinical trial protocol asean common technical document (actd)research. document (ectd) electronic common technical common technical document (ctd) drug master files (dmf) technical documentation registration of indian drug product in overseas ma canada (organization structure and types of applic japan australia european union united states overview of regulatory authorities of india abbreviated new drug application (anda). changes t new drug application (nda) approval processes and timelines involved in inves generic drug product development. concept of generics innovator and generics clinical studies non-clinical activities pre-clinical studies drug development process stages of drug discovery regulatory requirements and approval procedures fo certificate of pharmaceutical product (copp) responsibilities central drug standard control organization (cdsco) indian regulatory requirements glp nabl iso 14000 introduction to iso 9000 series of quality systems change control out of specifications (oos) six sigma concept quality by design (qbd) total quality management quality management & certifications: concept of qu quality management systems management of clinical studies. data presentation for fda submissions biostatistics in pharmaceutical product developmen clinical research protocols clinical research / be studies investigator’s brochure (ib) and new drug applicat general considerations of investigational new drug drug metabolism and toxicology pharmacology non-clinical drug development drug development teams regulatory requirements for drug approval responsibility of regulatory affairs professionals role of regulatory affairs department regulatory authorities historical overview of regulatory affairs introduction ra regulatory affairs pilot plant scale up techniques 2019-2020 sem-vii b. pharm. final year cranial nerves spinal nerves synapsis angioplasty pulmonary circuit hypertension heart attack heart cardiovascular system
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