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preparation application evaluation polyclonal monoclonal antibody monoclonal antibody cosmetics formulation challenges herbal cosmetics active transporters drug distribution permeability solubility modeling techniques drug disposition therapeutics oligonucleotide based therapeutics nucleoside nucleotide oligonucleotide dna proton hydrogen nmr nmr coupling constant coupling spin-spin coupling micro emulsion emulsion drug delivery system self micro-emulsifying drug delivery smedds medicines ans healthcare regulatory agency cdsco therapeutic good administration approval market authorization ema tga mhra european union regulatory affairs regulatory requirements tablet layout pharmaceutical building layout of building gmp cgmp medicinal product dossier investigation of medicinal product dossier impd himal spectroscopy atomic absorption spectroscopy flame emission spectroscopy chemistry manufacture control medical devices combination product regulations post approval cmc