JNTUK B.Tech Regulatory Affairs, IPR & Patents gives you detail information of Regulatory Affairs, IPR & Patents R13 syllabus It will be help full to understand you complete curriculum of the year.
Unit-I : Preformulations and Formulation Development – Regulatory requirements in Preformulations and Formulation Development of Solid, liquid and Semisolid dosage.
LO : To understand preformulations – protocols – regulatory – requirements – Formulation Development of Solid, liquid and Semisolid dosage.
Unit-II : Manufacturing- Regulatory requirements related to manufacturing-manufacturing formula,Records, Validations involved-GMP Validations: Types- Validation of Process and Equipment – Raw materials, Excipients and solvents.
LO : To understand regulatory requirements related to manufacturing, validation – types, Validation of process, equipment, raw materials, excipients.
Unit-III : Regulatory requirements of packaging materials– Evaluation of Packaging materials. Stability – Regulation for Stability testing of API, Solid and liquid dosage form as per ICH guidelines.
LO : To understand regulatory requirements of packaging materials, evaluation of packaging materials, stability testing as per ICH.
Unit – IV : Clinical Trials : Phase –I, II, III & IV studies – Regulations involved
LO : To understand regulatory requirements of Clinical Trials, Phase –I, II, III & IV studies.
Unit- V : A Study of Intellectual Property Rights : Definitions – Guidelines – National and international – Examples.
LO : To understand IPR with examples .
Unit- VI : Patents: patenting laws and Regulations – Procedures for obtaining and writing a patent – Examples.
LO : To understand patents, patent laws, procedures with examples.
References
- Quality Assurance guide by organization of Pharmaceutical Procedures of India
- Drug formulation manual by D.P.S.Kohli and D.H.Shah. Eastern Publishers, New Delhi.
- How to Practice GMPs By P.P.Sharma, Vandhana Publications, Agra.
- Pharmaceutical Process Validation by FRA.R.Berry and Robert.A.Nash.
- Pharmaceutical Preformulations by J.J.Wells.
- Applied Production and Operations management by Evans, Anderson, Sweeny and Williams.
- Basic principles of Clinical Research and methodology by Guptha.
- Biopharmaceutics and Clinical Pharmacokinetics – An Introduction ; 4th Edition, Revised and Expanded by Robert E. Notary, Marcel Dekker incm, New york and Basel, 1987.
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