FORENSIC PHARMACY (PHARMACEUTICAL JURISPRUDENCE)

1. Evolution of Pharmaceutical and Drug Legislation in India. 

2. The Pharmacy Act 1948. 

3. Code of Pharmaceutical Ethics. 

4. Consumer protection Act 1986. 

5. Narcotic and Psychotropic substances Act 1985. 

Drugs and Cosmetics Act 1940 and Drugs & Cosmetic Rules 1945 (also amendments). 

 1. Administration of the Act – The controlling and licensing regulation at state level and central level (the organisation, function and duties of state and central drug control authorities). 

 2. Drugs & Cosmetic Act Rules – the provisions related to  

 a. The manufacture of drugs (other than homeopathic) including schedule C, C(1), F, F(1) and X drugs and cosmetics. 

 b. The sale and distribution of drugs (other than homeopathic) including schedule C, C(1), F, F(1) and X drugs and cosmetics. 

Drugs & Cosmetics Act Rules  

1. (i.) The import and export of drugs & cosmetics. 

    (ii) Labelling and packing requirements for all categories of drugs & cosmetics. 

2.  (i.)  List of schedules to the Drugs & Cosmetics Rules. 

     (ii.) Detailed study of schedule M (new), U and Y. 

3.  Medicinal & Toilet preparations (Excise Duties) Act 1955. 

 1. Drugs and magic Remedies (Objectionable Advertisments) Act 1954. 

 2. Prevention of Food Adulteration Act 1954 (salient features) 

 3. The Factories Act 1948 and the Amendment (salient features.). 

IPR’s and Patent Laws  

 1. Intellectual Property Rights – a brief introduction to various IPR’s. 

 2. Indian Patent Act 1970 and the Amendments to the Act (upto date with reference to WTO Agreement) 

 a. Introduction & Objectives 

 b. Inventions and Not inventions according to the Act. 

 c. Procedure of obtaining patent for drugs and pharmaceuticals. 

 3. Drug Price Control Order (Latest). 

 4. Pharmaceutical Policy 2002. 

BIOSTATISTICS (PHARMACOSTATISTICS)

Definition and determination of terms Mean, Median, Mode, relation between mean, median, and mode. Standard deviation, histogram, Coefficient of correlation, regression analysis, curve fitting, theory of probability. 

 

Nature and Scope of Statistical methods and their limitations, compilation, classification, tabulation and applications in pharma and life sciences; Graphical representation; Measures of Average Stem and Leaf Plots; Box and Whisker Plots, Co-plots; Introduction to Probability Theory and Distributions (Concepts without Derivations), Binomial, Poisson & Normal Distributions (Only definition and Problems) 

  

Sampling Methods: Simple, Random, stratified, Systematic and Cluster Sampling Procedures; Data Collection, Data Organization and Data Representation; Bar, Pie, 2-D and 3-D Diagrams; Sampling and Non-Sampling Errors; Sampling Distributions; measure of dispertion.

 

Interference Concerning Means: Point Estimation - Interval estimation - Bayesians estimation - Tests of Hypothesis; Common Parametric and Non parametric tests employed in testing of significance in biological/pharmaceutical experiments.   

Tests of significance - T -test, chi-square test, analysis of variance, elements of Anova (one way and two way). Principles of scientific experiments; concept of CRD, RBD and Latin square diagrams. 

BIOPHARMACEUTICS AND PHARMACOKINETICS

Biopharmaceutics 

Introduction & their role in formulation development & clinical settings, fate of drugs after administration. 

Drug absorption: drug absorption mechanisms, factors affecting drug absorption (physiochemical, biological, metabolic, formulations and dosage form considerations). 

Drug distribution & protein binding of drugs 

Distribution of drug through organ /tissue - factors affecting distribution 

(Physicochemical properties of drugs, organ/tissue size, blood flow to the organ, physiological barriers  to the distribution of drugs, drug binding blood / tissue / macromolecules). 

Protein /tissue binding of drugs- factors affecting protein binding of drugs, significance and kinetics, tissue binding of drugs. 

Drug metabolism & excretion of drugs 

Biotransformation of drugs- drug metabolizing enzymes & organs, phase I & phase II reactions, factors affecting biotransformation, drug metabolism significance, extrahepatic metabolism, pharmacological activity of metabolite, deposition of metabolite. 

Excretion of drugs - renal excretion of drug, factors affecting renal excretion of drugs, nonrenal routes of excretion of drug & factors affecting them, enterohepatic circulation. 

Pharmacokinetics 

Introduction, basic concepts- rate processes in biological systems, pharmacokinetics parmneters- Cmax, tmax, AUC, biological half life, apparent volume of distribution, clearance (hepatic, renal, organ, metabolite). 

Pharmacokinetics drug interaction and their significance in combination therapy. 

Clinical pharmacokinetics: dosage adjustment in patient with and without renal and hepatic failure. 

Compartment models 

Basic concepts, one & two compartment models- pharmacokinetics of drug absorption, distribution and elimination under following conditions: 

 i) Intravenous bolus injection 

ii) Intravenous infusion 

iii) Oral single dose 

Application of pharmacokinetic principles & computation of parameters by graphical approach. 

PHARMACEUTICAL ANALYSIS – II (INSTRUMENTAL METHODS OF ANALYSIS)

UV /Visible Spectroscopy 

Regions of Electromagnetic spectrum, properties of EMR, atomic and molecular spectra, Beer - Lambert's law and deviations from Beer's law Principles and theoretical aspects of UVN/Visible Spectroscopy, electronic transition, effect of conjugation, concept of chromophore and auxochrome, bathochromic, hypsochromic, hyperchromic and hypochromic shifts Instrumentation - components of spectrophotometer, types of spectrophotometers, Solvents and sample handling, Applications - Qualitative and quantitative analysis - single component 

IR spectroscopy 

Principles and theoretical aspects - Molecular vibrations, Hook’s Law, Intensity and position of IR bands, Measurement of IR spectrum, finger print region and characteristic absorption of various functional groups. 

Instrumentation - Spectrophotometer components, Sample preparation and handling Application - Interpretation of IR spectra of simple organic compounds, quantitative applications. 

i)NMR - A brief introduction to the principle and instrumentation, chemical shift, spin-spin interaction, shielding and de shielding. 

ii)MS - A brief introduction to the principle and instrumentation, various methods of ion production and fragmentation rules. 

iii)Fluorescence spectroscopy - Fundamentals, radiative and non radiative process, mirror image relation ship, fluorescence and molecular structure, properties of fluorescence. Instrumentation - components of spectrofluorimeter and applications 

Electrochemical methods 

i) Amperometric titrations 

ii) Potentiometry - principles and theoretical aspects - electrodes, measurement of cell potential, end point evaluation methods, potentiometric titrations, Null point potentiometry and application. 

iii) Conductometry - principles and theoretical aspects, conductance, equivalent and molar conductance, effect of dilution on conductance, conductivity water, cell constant, conductivity cell, measurement of conductivity, conductimetric titrations and applications. Other analytical techniques - Principle, Instrumentation and application of following instrumental methods of analysis nephelometry, turbidometry, flame photometryand differential thermal analysis 

Chromatography: Principle, instrumentation and experimental details and applications of paper chromatography, TLC, column chromatography, gas chromatography, HPLC and HPTLC. 

Electrophoresis : Principle, instrumentation, experimental details and applications of paper and gel electrophoresis . 

MEDICINAL CHEMISTRY-II

Local Anesthetics - (Lidocaine and Bupivacaine). 

Narcotic analgesics - (Pethidine and Fentenyl), Narcotic antagonists - (Nalaxone), 

Peripheral analgesics, Antipyretics & Anti-inflammatory agents - (Aspirin, Paracetamol, Piroxicam, Ibuprofen and Diclofenac Sodium). 

Anti-neoplastic agents - (Chlorambucil, Busulfan, Fluorouracil, Methotrexate and Tamoxifen), 

Chemotherapeutic agents, Sulfonamides - (Sulphamethoxazole and Sulphadioxine) Antibiotics - General Classification of Antibiotics; Beta-Iactam antibiotics - (Penethicillin, Ampicillin, Cloxacillin); Cephalosporins - (Cephalexin); Tetracyclines - (Chlortetracycline, Oxytetracycline), Quinolones - (Norfloxacin and Ciprofloxacin); Aminoglycosides, Macrolides, Polypeptides; Miscellaneous - (Chloromphenicol and Novobiocin). 

Antituberular drugs - (INH, PAS, Ethambutol); Antileprotic drugs - (Dapsone); Antifungal drugs - (Ketoconazole and Fluconazole); Antiviral drugs - (Zidovodine ); Antimalarial drugs - (Chloroquine, Pyrimethamine, Primaquine); Anthelmentic drugs - (Diethyl carbamazine citrate, Albendazole, Niclosamide, Pyrantel formate and Piperazine citrate); Antiprotozoal drugs - (Metronidazole, Tinidazole). 

Drugs acting on CNS: CNS stimulants and psychotropic agents - (Imipramine and Amiryptiline ), 

General Anesthetics - (Halothane, Ketamine, Enflurane), 

Sedative & Hyponotics - (Phenobarbitone, Glutethimide, Zolpiclone), Anxiolytics - (Diazepam, Medazolam, Buspirone). 

Antipsychotic (Tranquilizing) agents: (Chlorpromazine, Thiothixene, Haloperidol and Pimozide) 

Anticonvulsants - (Phenytoin, Carbamazepine, Ethosuximide), 

Antiparkinsonism drugs - (Benztropine and Carbidopa).